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The ACPMP Research Foundation attempts to keep this list as updated and complete as possible. Please note, however, that the primary public sources from which this list is compiled do not always reflect the most recent changes to enrollment status, and there may be changes to the enrollment status or new trials added that are not yet reflected in the periodic updates provided. Nevertheless, the below list of clinical trials, and the contact information provided for each, is intended to provide sufficient baseline information for use by any individual interested in further exploring potential eligibility and participation.
For more information on clinical trials for appendix cancer and/or pseudomyxoma peritonei or to update any of the information below, please contact Deborah Shelton.
CLINICAL TRIALS OVERVIEW
Clinical studies (often also commonly referred to as clinical trials or clinical research) can have many different objectives, depending on the specific study. Such objectives may include, for example, developing new treatments, identifying causes of a disease or condition, studying trends, and evaluating ways in which genetics may be related to a disease or condition.
Typically, a new therapy or procedure is first tested in the laboratory and in animal studies, and, if the results merit further investigation, it is then moved into a clinical trial (ie., tested in humans). The clinical trial testing is conducted in phases (generally Phase 1, 2, and 3, each of which is briefly explained below). Depending on the particular phase, clinical trials are designed to obtain more detailed information about the investigational therapy, including its safety profile, risks, and effectiveness.
Sometimes a patient decides to participate in a clinical trial because none of the treatments otherwise available have worked, or they find them to have side effects that are not tolerable. In this way, clinical trials can sometimes provide another option when standard therapies have failed. Other patients participate in a clinical trial because they want to contribute to the advancement of medical knowledge. Often, an individual that decides to participate in a clinical trial does so with both goals in mind.
The study of an investigational drug in humans proceeds in phases, with the information learned from each phase used to build upon the next: generally Phase 1, 2, and 3.
Clinical trials – particularly for new cancer therapies – are sometimes collapsed. In other words, some researchers design these trials to combine to phases into a single study protocol (e.g., Phase 1/2, or Phase 2/3). The reason for this type of design is to help facilitate a more seamless transition between phases, potentially allowing research questions to be answered more quickly or with fewer patients.
The National Cancer Institute (NCI) provides the following examples of benefits and risks of participating in a clinical trial that should be considered in deciding whether a clinical trial may be right for you:
Potential Benefits: may include having access to a new therapy that is not otherwise available; close monitoring by the clinical research team; being among the first to benefit from a therapy that is determined to be more effective than the standard treatment; and helping researchers learn more about your type of cancer; and benefitting the larger patient population in the future.
Potential Risks: may include the investigational treatment may be inferior to the standard treatment, or may not work for the individual patient at all; there may be unanticipated side effects or worse side effects than the standard treatment; increased doctors visits and associated expenses, including travel and logistical support; extra tests may be required that may be both time-consuming and uncomfortable; and a patient’s health insurance may not cover all patient costs in a clinical trial.
For additional information, see NIH's Clinical Trials Information for Patients and Caregivers and our helpful links page under Clinical Trials
A phase 1 study is early testing in humans. Its purpose is to determine dosing, safety and tolerance of an investigational drug and to gather information about its biological activity within the body.
Once an acceptable margin of safety is established for the investigational drug, Phase 2 begins. A Phase 2 study is generally the first study in which primary measurements will be made to determine efficacy of the investigational drug. In terms of the a study’s objectives, though, the line between a Phase 1 and Phase 2 study can sometimes be somewhat blurred, particularly in the case of oncology trials where there is a small study population and interest in expediting development process while appropriately safeguarding patient safety.
A Phase 3 study is a large, pivotal safety and effectiveness trial. Information gathered during this stage includes additional evidence of safety and efficacy, long-term tolerance, drug interactions, etc.
CURRENT CLINICAL TRIALS
The compilation of clinical-trial information provided is organized as follows: (1) the name of the clinical trial, and the study identifier and link to the clinicaltrials.gov registry providing more detailed information; (2) a brief summary of the protocol/objectives of the trial, (3) key baseline eligibility criteria, and (4) study contact information. Please note that the eligibility criteria for any given clinical trial are typically extensive, and thus not detailed in the list of clinical trials provided here. All of the inclusion and exclusion criteria can be accessed, however, through the clinicaltrials.gov link provided for that particular trial and should be discussed further with your physician and/or the contact person listed for that clinical trial. Examples of common eligibility for a clinical study of a new investigational cancer drug include (a) having a specific type or stage of cancer; (b) having received or not received a certain kind of prior therapy; (c) having specific genetic changes in your tumor; (d) medical history; and (e) current health status.
Each clinical trial is assigned a specific identifier; the identifier is referred to formally as the NCT number in the U.S. and is the registry number as provided in the listing for that trial at ClinicalTrials.gov. The NCT number and the corresponding link to the full listing on ClinicalTrials.gov is provided for each clinical trial listed here where applicable.
The following is a list of current clinical trials but may be of interest to AC/PMP patients. This list is organized by (1) phase of trial, and then (2) within each phase, the type of trial (i.e., (A) Appendix Cancer-Specific; (B) Specific Tumor Mutations/Characteristics; and (C) Solid Tumors Generally). For your additional information, each of these types of trials is described briefly below:
Appendix Cancer-Specific:
These trials are focused, at least in part, directly on Appendix Cancer and PMP.
Specific Tumor Mutations/Characteristics:
Specific Tumor Mutations/Characteristics clinical trials focus on the study of what is sometimes referred to as tumor-agnostic treatments. Tumor-agnostic treatments are drugs that are used to treat any type of cancer, regardless of the organ or type of tissue from which the cancer originally developed. Instead of the primary site of tumor origin, a tumor-agnostic treatment focuses on the tumor’s genetic make-up, including specific mutations or biomarkers. In other words, this type of therapy can be used when a person’s tumor has a very specific molecular alteration that is targeted by the drug or predicts that the drug is likely to work.
Solid Tumors Generally:
Although some of the trials listed below are so-called tumor-agnostic trials, some of the trials listed below involve solid tumors generally rather than appendix cancer specifically or tumors with specific mutations. We call these trials “other non-specific tumor” clinical trials.
Temporarily Suspended:
Clinical trials that are not enrolling at this time. They are currently suspended, pending the Sponsors' analysis of results from the dose-escalation phase (Part 1) to establish the eligibility criteria for the dose-expansion phase (Part 2). We will try to monitor and update with any changes.
The first group of tumor-agnostic (and other non-specific tumor) trials listed below are Phase 2 trials. The second group of tumor-agnostic listed beneath those are Phase 1/2 trials.
PHASE 1 CLINICAL TRIALS
Appendix Cancer-Specific
Trials in U.S.
Location(s): City of Hope (Duarte, California); Northwell Cancer Institute (New York, New York); and Mayo Clinic (Jacksonville, Florida)
Brief Description: This is a Phase 1 study of the side of effects of pressurized intraperitoneal aerosol chemotherapy (PIPAC) in treating patients with cancer that has spread to the lining of the abdominal cavity (i.e., peritoneal carcinomatosis). PIPAC is administered via laparoscopy. The pressurization of the liquid chemotherapy through the study device (a nebulizer) results in aerosolization (a fine mist or spray) of the chemotherapy introduced into the abdomen. Giving chemotherapy through PIPC may reduce the amount of chemotherapy needed to achieve acceptable drug concentration, therefore potentially reducing side effects and toxicities.
The chemotherapy agents to be administered to appendiceal cancer patients participating in this study are cisplatin and doxorubicin.
Baseline Eligibility Criteria include but are not limited to:
- Histologically confirmed appendiceal cancer with peritoneal metastases
- No contraindication for laparoscopic procedure
- No evidence of impending bowel obstruction and no current bowel obstruction requiring NG tube, gastrostomy or exclusive TPN
- Less than 5 liters of ascites (ie, room for aerosol therapy)
- Not a candidate for HIPEC
Contact(s): City of Hope: Dr. Thanh Dellinger – tdellinger@coh.org; 626-218-1379; Northwell Cancer Institute: Dr. Richard Whelan – rwhelan1@northwell.edu; 212-434-4860; Mayo Clinic: Dr. Amit Merchea - Merchea.Amit@mayo.edu; 904-953-2596
Location: National Institutes of Health Clinical Center, Bethesda, Maryland
Brief Description: This is a Phase 1 clinical trial to determine if HIPEC (heated intraperitoneal chemotherapy) can be improved by testing different chemotherapy drugs, using a model called the SMART (Sample Microenvironment of Resected Metastatic Tumor) System. Approximately 60 patients will be enrolled across all cancer types, including appendiceal, that are subject of this study (see title for full listing)
Baseline Eligibility Criteria (as applies to appendix cancer):
- Confirmation, by the National Cancer Institute Laboratory of Pathology of peritoneal carcinomatosis from appendix cancer
- Assessed as being able to undergo complete cytoreduction with PCI (peritoneal carcinomatosis index) score of 30 or greater based at the time of laparoscopy
- No known extra-abdominal metastatic disease
- No history of allergic reactions to platinum-containing compounds
- No history of dihydropyrimidine dehydrogenase deficiency
Contact: Audra Satterwhite, R.N. at 240-858-3552 (telephone) or audra.satterwhite@nih.gov (e-mail)
Individualized Dose Escalation of 5-FU for Gastrointestinal Cancer (NCT05780684)
Location: Dartmouth-Hitchcock Medical Center (Lebanon, New Hampshire)
Brief description: This is a Phase I study, evaluating the feasibility and effectiveness of a chemotherapy regimen adaptive, individualized dose escalation of 5-FU chemotherapy for patients who have good tolerance of the initial dose. Study participants will also receive oxaliplatin chemotherapy together with 5-FU, at standard doses. Approximately 36 participants will be enrolled.
Baseline Eligibility Criteria include, but are not limited to:
- Diagnosis of metastatic or locally advanced/inoperable colorectal cancer or non-colorectal gastrointestinal cancer (including cancers appendix)
- No prior receipt of oxaliplatin or fluoropyrimidine chemotherapy (other than radiation-sensitizing fluoropyrimidine chemotherapy)
- No known mismatch repair deficiency or microsatellite instability-high disease
- No known dihydropyrimidine dehydrogenase (DPD) deficiency
Contact: Study Contact: Research Nurse at 603-653-3637 (telephone) or cancer.research.nurse@hitchcock.org (email); Med Center Contact: Gabriel A Brooks, MD, PI, at 603-650-9474 (telephone) or gabriel.a.brooks@hitchcock.org (email)
Trials Outside of U.S.
Location: Ghent, East-Flanders, Belgium (Ghent University Hospital)
Brief description: The Phase I study is designed to examine the maximal tolerated dose of an nanoliposomal irinotecan (Nal-IRI) administered with repeated pressurized intraperitoneal aerosol chemotherapy (PIPAC). Approximately 45 participants will be enrolled.
Baseline Eligibility Criteria include, but are not limited to:
- Biopsy proven cancer of the appendix with extensive or non-resectable peritoneal carcinomatosis
- No concomitant systemic (IV) treatment with irinotecan (either as monotherapy or as part of a combination regimen such as FOLFIRI, CAPIRI, or FOLFOXIRI)
- No significant amount of ascites detectable (exceeding 3l in volume)
- No intestinal or urinary tract obstruction
- No known use of CYP3A4 inducers and inhibitors of CYP3A4 or UGT1A1
Contact: Hospital Contacts: Wim P Ceelen, MD, PhD, Prof, at +3293326251 (telephone) or wim.ceelen@ugent.be (email); Wouter Willaert, MD, PhD, Prof, at +3293328950 (telephone) or wouter.willaert@ugent.be (email)
Specific Tumor Mutations/Characteristics
TP53
Trials in U.S.
Location: Multiple U.S. sites (CA, MA, NJ, OR, TX). To view specific sites, click here.
Brief Description: This is a Phase 1 study to evaluate the safety and preliminary anti-tumor activity of NT-175, an autologous T cell therapy investigational product, in Human Leukocyte Antigen-A*02:01-Positive adult subjects with unresectable, advanced and/or metastatic solid tumors that are positive for the TP53 R175H mutation. Approximately 24 participants will be enrolled.
Baseline Eligibility Criteria include, but are not limited to:
- Diagnosed with a solid tumor
- Tumors must harbor a TP53 R175H variant mutation and subject must be HLA-A*02:01 positive (at least 1 allele)
- Has advanced solid cancer, defined as unresectable, advanced, and/or metastatic disease (Stage III or IV) after at least 1 line of approved systemic standard of care (SOC) treatment regimen and for which there are no available curative treatment options *
- At least 1 measurable lesion *
Contact: Study Contact: Neogene Medical Affairs at (310) 742-9929 (telephone) or MedicalAffairs@neogene.com (email); To view specific contact information for each site, click here.
Trials Outside of U.S.
Combination of CAR-DC Vaccine and ICIs in Malignant Tumors (NCT05631886)
Location: Biotherapeutic Department of Chinese PLA General Hospital (Beijing, China)
Brief description: This is a Phase I study of subjects with local advanced/metastatic solid tumors or relapsed/refractory (R/R) lymphomas to determine the safety, efficacy and immune response of autologous EphA2-targeting CAR-DC vaccine loaded with TP53 mutant peptide (TP53-EphA-2-CAR-DC) in combination with ICIs. Approximately 10 participants will be enrolled.
Baseline Eligibility Criteria include, but are not limited to:
- Local advanced/metastatic solid tumors or R/R lymphomas confirmed by histopathology or cytology with documentation of tumor EphA2 positive (≥20%) and TP53 mutation (R273H or R175H or R248Q or R249S). The second malignancy is allowed.
- No clinical response to standard frontline therapy or no standard therapy exists for solid tumors. Relapse after treatment with ≥2 lines systemic therapy or refractory disease for lymphomas. Patients who have declined standard therapy or have no access to standard therapy may be enrolled and the reasons for a lack of access need to be documented. Previous treatment with anti-PD-1/PD-L1 antibodies or anti-CTLA4 antibody are allowed, regardless of the level of PD-1/PD-L1 expression, dMMR and TMB.
- At least one measurable lesion at baseline per RECIST version 1.1 or Lugano response criteria 2014 *
- No TP53 (R273H or R175H or R248Q or R249S) germline mutation.
- No previous treatment involving TP53 mutant (R273H or R175H or R248Q or R249S) and EphA2
Contact: Study and Hospital Contact: Weidong Han, Ph.D, at 010-66937231 ext +86 (telephone) or 86-010-66937463 (telephone) or hanwdrsw69@yahoo.com (email) or hanwdrsw@sina.com (email); Study Contact Backup: Yang Liu, M.D, at 010-66939460 ext +86 (telephone) or liuyang301blood@163.com (email)
KRAS
Trials in U.S.
NEROFE and Doxorubicin in KRAS-mutated ST2-positive Solid Tumors (NCT05661201)
Location: Georgetown Lombardi Comprehensive Cancer Center (District of Columbia, WA)
Brief Description: This is a Phase I study, assessing the safety and efficacy of a combination of an investigational drug combination (NEROFE, a peptide) and doxorubicin in patients with advanced/unresectable or metastatic solid KRAS-mutated ST-positive solid tumors. The primary objective is to determine the recommended dose and schedule for administering. Approximately 24 participants will be enrolled.
Baseline Eligibility Criteria include, but are not limited to:
- Advanced/unresectable or metastatic solid tumor with a pathogenic KRAS mutation
- Presence of tumor ST2 expression
- Progression or intolerance to all standard therapies, patient may decline standard therapies and retain eligibility (patients must not have available curative options)
- Have measurable disease by RECIST v. 1.1 *
- Suitable, stable venous access to allow for all study-related blood sampling
- No prior exposure to anthracycline chemotherapy
- Not receiving any active anti-cancer therapy while on study treatment
- No concurrent use of an aromatase inhibitor
Contact: Jennifer Montcalm at 202-687-8974 (telephone) or jem257@georgetown.edu (email)
Location: Cincinnati, OH (Lindner Center at the Christ Hospital); Houston, TX (MD Anderson); Salt Lake City, UT (Huntsman Cancer Institute)
Brief Description: This is a Phase I study to evaluate the safety, tolerability, pharmacokinetics and preliminary anti-tumor activity of an investigational drug (Pan-RAS Inhibitor YL-1723)1 in patients with advanced solid tumors harboring mutations in KRAS, HRAS, or NRAS. Approximately 60 participants will be enrolled.
Baseline Eligibility Criteria include, but are not limited to:
- Unresectable or metastatic advanced solid tumors with no standard therapies, or having progressed on or intolerable to standard therapies.
- Advanced solid tumors harboring mutations in KRAS, HRAS or NRAS
- Measurable disease with at least one lesion amenable to response assessment per RECIST 1.1 *
- No concurrent chemotherapy, immunotherapy, or biologic or hormonal therapy for cancer treatment.
- No condition that impairs a patient's ability to swallow whole pills.
- No presence of an active gastrointestinal disease or other condition that will interfere significantly with the absorption, distribution, metabolism, or excretion of YL-17231
Contact: Study & MD Anderson Contact: David S. Hong, MD, at (713) 563-1930 (telephone) or dshong@mdanderson.org (email); Lindner Center Contact: Alexander Starodub at 513-321-4333 (telephone); Hunstman Contact: Ignacio Garrido-Laguna at 801-585-0255 (telephone)
QTX3034 in Patients With KRAS G12D Mutation (NCT06227377)
Location: South TX Accelerated Research Therapeutics (San Antonio, TX); Huntsman Cancer Center (Salt Lake City, UT); Next Oncology VA (Fairfax, VA)
Brief Description: This is a Phase I study evaluating the safety and efficacy of an investigational drug (QTX3034) as a single agent, and in combination with cetuximab, in patients with solid tumors with KRASG12D mutation. Approximately 250 participants will be enrolled.
Baseline Eligibility Criteria include, but are not limited to:
- Pathologically documented, locally advanced or metastatic malignancy with KRAS G12D mutation
- No prior treatment with a KRAS inhibitor
- [Part 1]: Advanced solid tumors with at least 1 prior systemic therapy AND Evaluable or Measurable disease per RECIST 1.1 *
- [Parts 2 & 3]: Measurable disease per RECIST 1.1 *
Contact: Study Contact: Quanta Therapeutics Clinical Trials, at 415-599-3892 (telephone) or clinicaltrials@quantatx.com (email); TX Contact: Isabel Jimenez, RN, MSN, at 210-593-5265 (telephone) or isabel.jimenez@startsa.com (email); UT Contact: Susan Sharry, at 801-585-3453 (telephone) or susan.sharry@hci.utah.edu (email); VA Contact: Blake Patterson, at 703-783-4505 (telephone) or bpatterson@nextoncology.com (email)
Location: Multiple U.S. sites (CA, FL, MI, MO, and OH). One location in Rio Piedras, Puerto Rico. To view specific sites, click here.
Brief Description: A Phase 1 dose escalation study in patients with advanced malignant solid tumors harboring KRAS G12C mutation to determine the maximum tolerated dose and recommended Phase II dose of an oral investigational drug (KRAS G12C inhibitor: HBI-2438) and characterize its pharmacokinetic profile. Approximately 44 participants will be enrolled.
Baseline Eligibility Criteria include, but are not limited to:
- Advanced malignant solid tumors with KRAS G12C mutation
- Failed or refused standard of care therapy, are not eligible for standard of care therapy, or cannot benefit from standard of care therapy
- At least 1 measurable target lesion that meets the definition of RECIST v1.1 *
- Able to swallow oral medications and must not have gastrointestinal abnormalities that significantly affect drug absorption
- No prior treatment with any KRAS G12C inhibitors
Contact: Study Contact: John Ning, MD,PhD,FAIC, at 858-280-1866 (telephone) or jning@huyabio.com (email); To view specific contact information for each site, click here.
Location: Multiple U.S. sites (CA, MO, NY, TN). To view specific locations, click here.
Brief Description: This is a Phase I study to evaluate the safety and preliminary anti-tumor activity of an autologous, engineered T-cell therapy (NT-112) in Human Leukocyte Antigen-C*08:02-positive adult subjects with unresectable, advanced, and/or metastatic solid tumors that are positive for the KRAS G12D Mutation. Approximately 24 participants will be enrolled.
Baseline Eligibility Criteria include, but are not limited to:
- Diagnosed with a solid tumor
- Tumors must harbor a KRAS G12D variant mutation and subject must be HLA-C*08:02 positive
- Subject has advanced solid cancer, defined as unresectable, advanced, and/or metastatic disease (Stage III or IV) after at least 1 line of approved systemic standard of care (SOC) treatment regimen and for which there are no available curative treatment options.
- At least 1 measurable lesion per RECIST v1.1 *
Contact: Neogene Medical Affairs, Study Contact, at (310) 742-9929 (telephone) or MedicalAffairs@neogene.com (email); To view specific contact information for each site, click here.
A Study of ASP3082 in Adults With Previously Treated Solid Tumors (NCT05382559)
Location: Multiple sites in the U.S. and Japan. To view specific locations, click here.
Brief Description: This is a Phase I study of an investigational drug (ASP3082) as a single agent and in combination with either cetuximab or chemotherapy in participants with previously treated locally advanced or metastatic solid tumor malignancies with KRAS G12D mutation. Approximately 541 participants will be enrolled.
Baseline Eligibility Criteria include, but are not limited to:
- Locally advanced (unresectable) or metastatic solid tumor malignancy with documented KRAS G12D mutation and has received prior standard therapy and the investigator does not see any further clinical benefit from continuing such targeted therapy, or is ineligible to receive or has refused standard approved therapies (no limit to the number of prior treatment regimens).
- No prior treatment with a specific KRAS G12D inhibitor/degrader or pan-RAS inhibitor/degrader targeting KRAS G12D
- At least 1 measurable lesion per RECIST v1.1. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions. *
- Participant agrees not to participate in another interventional study while receiving study intervention (Participants who are currently in the follow-up period of an interventional clinical trial are allowed).
- Not expected to require another form of antineoplastic therapy while on study treatment.
- [ASP3082 Alone Escalation Cohorts]: participants with solid tumor malignancies are allowed to be enrolled.
- [ASP3082 and Cetuximab Cohorts]: Participants who received prior treatment with a KRAS G12D inhibitor/degrader are eligible
Contact: Astellas Pharma Inc. at 800-888-7704 (telephone) or astellas.registration@astellas.com (email)
Location: National Institutes of Health Clinical Center (Bethesda, Maryland)
Brief Description: This is a Phase Ib study to evaluate the administration of autologous T-cells genetically engineered to express receptors reactive against KRAS mutations in conjunction with a vaccine directed against these antigens in participants with metastatic solid cancer. Approximately 210 participants will be enrolled.
Baseline Eligibility Criteria include, but are not limited to:
- Participants with an appropriate HLA match for available Surgery Branch KRAS TCRs with evaluable metastatic solid cancer (e.g., gastrointestinal and other solid cancers) with known KRAS G12V or G12D mutation.
- Confirmation of diagnosis of cancer by the NCI Laboratory of Pathology.
- Participants with solid tumors must have received at least one prior line of systemic treatment or have declined standard treatment.
- No form of secondary immunosuppression.
- No history of severe immediate hypersensitivity reaction to cyclophosphamide, fludarabine, aldesleukin or vaccines.
Contact: NCI SB Immunotherapy Recruitment Center, Study Contact, at (866) 820-4505 (telephone) or irc@nih.gov (email); Steven A Rosenberg, M.D., Study Contact Backup, at (240) 858-3080 (telephone) or sar@mail.nih.gov (email)
A Study to Find a Suitable Dose of ASP4396 in Adults With Solid Tumors (NCT06364696)
Location: START Midwest (Grand Rapids, MI); NEXT Oncology Dallas (Irving, TX); START Mountain Region (West Valley City, UT); NEXT Oncology VA (Fairfax, VA)
Brief Description: This is a Phase 1 study of an investigational drug (ASP4396) in participants with locally advanced (unresectable) or metastatic solid tumor malignancies with KRAS G12D mutation. This study consists of a dose escalation and expansion. Approximately 175 participants will be enrolled.
Baseline Eligibility Criteria include, but are not limited to:
- Locally advanced (unresectable) or metastatic solid tumor malignancy with documented KRAS G12D mutation and received prior standard therapy.
- At least 1 measurable lesion per RECIST v1.1 *
- Participants with asymptomatic and treated and stable CNS metastases are eligible.
- No other required form of anticancer therapy while on study intervention.
Contact: Astellas Pharma Inc. at 800-888-7704 (telephone) or astellas.registration@astellas.com (email)
Location: Multiple sites in the U.S. and other countries with various recruitment statuses. To view specific locations, click here.
Brief Description: This is a Phase Ia/Ib dose-escalation and dose-expansion study evaluating the safety, pharmacokinetics, and preliminary activity of an investigational drug (GDC-6036) alone and in combination with other anti-cancer therapies (Atezolizumab; Cetuximab; Bevacizumab; Erlotinib; investigational drug GDC-197; Inavolisib) in patients with advanced or metastatic solid tumors with a KRAS G12C mutation. Approximately 498 participants will be enrolled.
Baseline Eligibility Criteria include, but are not limited to:
- Histologically documented advanced or metastatic solid tumor with KRAS G12C mutation.
- No malabsorption or other condition that interferes with enteral absorption.
Contact: Reference Study ID Number: GO42144 https://forpatients.roche.com/; 888-662-6728 (U.S. and Canada telephone); global-roche-genentech-trials@gene.com (email)
Study of RMC-9805 in Participants With KRAS G12D-Mutant Solid Tumors (NCT06040541)
Location: Multiple U.S. sites. To view specific locations, click here.
Brief Description: This is a Phase I/Ib study to evaluate the safety and tolerability of an oral investigational drug (KRAS G12D(ON) inhibitor: RMC-9805) alone and in combination with another investigational drug (RMC-6236) in in adults with advanced KRAS G12D-mutant solid tumors. Approximately 444 participants will be enrolled.
Baseline Eligibility Criteria include, but are not limited to:
- Pathologically documented, locally advanced or metastatic solid tumor with a KRAS G12D-mutations
- Received and progressed or been intolerant to prior standard therapy (including targeted therapy) appropriate for tumor type and stage
- No known or suspected impairment of gastrointestinal function that may prohibit ability to swallow or absorb an oral medication
- Not previously treated with an investigational KRAS G12D inhibitor, pan- or multi-RAS inhibitor, or had prior therapy with any direct RAS-targeted therapy (eg, degraders and inhibitors)
Contact: Revolution Medicines, Inc. at (650) 779-2300 (telephone) or CT-inquiries@RevMed.com (email)
A Study of MK-1084 in KRAS Mutant Advanced Solid Tumors (MK-1084-001) (NCT05067283)
Location: Multiple sites in the U.S. and other countries. To view specific locations, click here.
Brief Description: This is a Phase I study evaluating the safety, pharmacokinetics, and efficacy of an investigational drug (MK-1084) alone and with therapies (Pembrolizumab; carboplatin; pemetrexed; cetuximab; oxaliplatin; leucovorin; 5-fluorouracil) in participants with advanced solid tumors with an identified KRAS G12C mutation. Approximately 830 participants will be enrolled.
Baseline Eligibility Criteria include, but are not limited to:
- Measurable disease by RECIST 1.1 criteria *
- [Arm 1]: Has locally advanced unresectable or metastatic solid-tumor malignancy with histologically OR blood-based confirmation of KRAS G12C mutation who has received at least 1 line of therapy for systemic disease
- [Arm 3; Group B]: Has locally advanced unresectable or metastatic solid-tumor malignancy, excluding non-small cell lung cancer or colorectal cancer, with histologically or blood- based confirmation of KRAS G12C mutation who has received at least 1 line of therapy for systemic disease
Contact: Toll Free Number at 1-888-577-8839 (telephone) or Trialsites@merck.com (email); To view specific contact information for each site, click here.
Location: Multiple U.S. sites. One location in San Juan, Puerto Rico. To view specific locations, click here.
Brief description: This is a Phase 1b study of two investigational drugs (RMC-6291 and RMC-6236) in combination in participants with advanced KRAS G12C-mutated solid tumors. This study will identify the maximum tolerated dose, the recommended Phase 2 dose and schedule, along with a preliminary assessment of the antitumor activity of RMC-6291. Approximately 210 participants will be enrolled.
Baseline Eligibility Criteria include, but are not limited to:
- Histology: pathologically documented, KRAS G12C-mutated, advanced or metastatic solid tumors not amendable to curative therapy
- [Part 1.Dose Escalation]: Solid tumors, previously treated
- [For Part 2.iv Dose Expansion]: Solid tumors, previously treated, naïve to KRAS G12C (OFF) inhibitors
- No known impairment of GI function that would alter the absorption
Contact: Revolution Medicines, Inc. at 650-779-2300 (telephone) or CT-inquiries@RevMed.com (email)
Location: Multiple U.S. sites. To view specific locations, click here.
Brief description: The main purpose of the study is to assess whether the study drug is safe and tolerable when administered to participants with locally advanced or metastatic solid tumors with certain KRAS mutations. The study drug will be given alone or in combination with other treatments. The study will have 2 parts: monotherapy dose escalation and dose optimization. The study is expected to last up to approximately 5 years.
Baseline Eligibility Criteria include, but are not limited to:
- Have evidence of KRAS G12C, G12D, G12V, G12A, G12S, or G13D mutation in tumor tissue or circulating tumor DNA
- Histological or cytologically proven diagnosis of a locally advanced, unresectable, and/or metastatic solid tumor cancer
- Have measurable disease per RECIST 1.1*
- Have an ECOG performance status of ≤1
Contact: Eli Lilly and Company at 317-615-4559 (telephone) or clinical_inquiry_hub@lilly.
QTX3544 in Patients with Advanced Solid Tumors with KRAS G12V Mutations (NCT06715124)
Location: Multiple U.S. sites. To view specific locations, click here.
Brief description: Phase 1 study to determine the safety, tolerability, and anti-tumor activity of QTX3544 as a single agent or in combination with cetuximab.
Baseline Eligibility Criteria include, but are not limited to:
- Pathologically documented, locally advanced or metastatic malignancy with KRAS G12V mutations.
- Part 1: Advanced solid tumors with at least one prior systemic therapy.
- Evaluable and measurable disease per RECIST v1.1.*
- Part 2 and 3: Measurable disease per RECIST v1.1.*
Contact: Quanta Therapeutics Clinical Trials at 415-599-3892 (telephone) or clinicaltrials@quantatx.com
Trials Outside of U.S.
Location: Multiple sites in Australia, Belgium, Canada, France, Italy, and Spain. To view specific sites, click here.
Brief Description:
This is a Phase I study, conducted to determine the safety and tolerability of an investigational drug (INCB161734) as a single agent or in combinations with cetuximab and retifanlimab in participants with advanced or metastatic solid tumors with KRAS G12D Mutation. Approximately 322 participants will be enrolled.
Baseline Eligibility Criteria include, but are not limited to:
- Locally-advanced or metastatic solid tumor with KRAS G12D mutation
- Disease progression on prior standard treatment, intolerance to or ineligibility for standard treatment, or no available standard treatment to improve the disease outcome
- Histologically or cytologically confirmed malignant solid tumor of any tissue origin
- Diagnosis of advanced solid tumor
- No prior treatment with any KRAS G12D inhibitor
Contact: Study Contact: Incyte Corporation Call Center (US), at 1.855.463.3463 (telephone) or medinfo@incyte.com (email); Study Contact Backup: Incyte Corporation Call Center (ex-US), at +800 00027423 (telephone) or eumedinfo@incyte.com (email)
CAR-DC Vaccine and ICIs in Local Advanced/Metastatic Solid Tumors (NCT05631899)
Location: Biotherapeutic Department of Chinese PLA General Hospital (Beijing, China)
Brief Description: This is a Phase I study for subjects with local advanced/metastatic solid tumors to determine the safety, efficacy and immune response of autologous EphA2-targeting CAR-DC vaccine loaded with KRAS mutant peptide (KRAS-EphA-2-CAR-DC) in combination with ICIs. It aims to assess the safety and antitumor effects of KRAS-EphA-2-CAR-DC vaccine and detect T cell response against KRAS mutant peptide and tumor neoepitopes after the treatment with KRAS-EphA-2-CAR-DC vaccine and ICIs. Approximately 15 participants will be enrolled.
Baseline Eligibility Criteria include, but are not limited to:
- Local advanced/metastatic solid tumors confirmed by histopathology or cytology with documentation of tumor EphA2 positive (≥20%) and KRAS mutation (G12V or G12D or G12C) within 6 months prior to screening. The second malignancy is allowed
- No clinical response to standard frontline therapy, or no standard therapy exists. Patients who have declined standard therapy or have no access to standard therapy may be enrolled and the reasons for lack of access need to be documented
- Previous treatment with anti-PD-1/PD-L1 antibodies or anti-CTLA4 antibody are allowed, regardless of the level of PD-1/PD-L1 expression, dMMR and TMB
- At least one measurable lesion at baseline per RECIST version 1.1 *
- No KRAS (G12V or G12D or G12C) germline mutation.
- No previous treatment involving KRAS mutant (G12V or G12D or G12C) and EphA2.
Contact: Study Contact: Weidong Han, Ph.D, at 010-66937231 ext +86 (telephone) or hanwdrsw@sina.com (email); Study Contact Backup: Yang Liu, M.D, at 010-66939460 ext +86 (telephone) or liuyang301blood@163.com (email)
Location: Xiangya Hospital of Central South University (Changsha, Hunan, China)
Brief Description: This is Phase I study, to evaluate the efficacy of an oral investigational drug (BEBT-607 tablets) in the treatment of patients with advanced or metastatic solid tumors with KRAS G12C mutation, and to determine the recommended dose for Phase II trials. Phase Ia is the dose escalation phase and phase Ib is the dose expansion phase. Approximately 126 participants will be enrolled.
Baseline Eligibility Criteria include, but are not limited to:
- Histologically confirmed locally advanced or metastatic solid tumors who have failed standard therapy, are intolerant to standard therapy, or have no standard therapy.
- Received at least systemic therapy and treatment failure
- Patients with stage I b are required to have at least one measurable lesion as defined by RECIST1.1 *
- For patients with KRAS G12C mutation, previously confirmed genomic KRAS GI2C mutation results
- No difficulty swallowing, suffering from malabsorption syndrome, impairment of gastrointestinal (GI) function, Gl diseases, or other diseases that may significantly affect the absorption through the intestine or metabolism of oral drugs
Contact: Study Contact: Kegang Jiang, Master, at +86-18664786382 (telephone) or kjiang@bebettermed.com (email); Study Contact Backup: Heli Liu, Ph.D, +86-13874967285 (telephone) or heliliu@csu.edu.cn (email); Hospital Contact (PI): Zhenhua Liu, at +86-18922136143 (telephone) or zhliu@bebettermed.com (email)
A Study of YL-17231 in Patients With Advanced Solid Tumors (NCT06078800)
Location: Sun Yat-sen University Cancer Center (Guangzhou, Guangdong, China)
Brief Description: This is a Phase I study to evaluate the maximum tolerance, safety, tolerance and pharmacokinetics of an oral investigational drug (YL-17231) in patients with advanced solid tumors with KRAS mutation, so as to confirm the recommended phase 2 dose and obtain the preliminary efficacy information of patients with advanced solid tumors with KRAS mutation. Approximately 80 participants will be enrolled.
Baseline Eligibility Criteria include, but are not limited to:
- Locally advanced or metastatic solid tumors diagnosed histologically and genomically confirmed with KRAS mutation
- At least one prior systemic treatment
- [Dose Escalation Phase]: measurable or non-measurable tumor lesions are acceptable based on RECIST1.1 criteria *
- [Dose Expansion Phase]: at least one measurable tumor lesion *
- No grade 3 or 4 gastrointestinal bleeding or variceal bleeding requiring transfusion, endoscopy, or surgical intervention within the past 3 months.
- No inability to swallow, chronic diarrhea, or intestinal obstruction that could affect medication intake and absorption.
Contact: Xu Ruihua, PhD, at 13922206676 (telephone) or xurh@sysucc.org.cn (email)
Location: Shanghai Pulmonary Hospital (Shanghai, China)
Brief Description: This is a Phase I study to evaluate the safety and tolerability of an investigational drug (HRS-4642) in patients with advanced solid tumors harboring KRAS G12D Mutation. This involves estimating the maximum tolerated dose and the recommended phase 2 dose. Approximately 108 participants will be enrolled.
Baseline Eligibility Criteria include, but are not limited to:
- Histologically confirmed diagnosis of advanced solid tumor harboring with KRAS G12D mutation
- Have at least one measurable lesion *
- Have not previously received KRAS G12D inhibitors
Contact: Study Contact: Wei Shi, at +021-61053363 (telephone) or Wei.shi@hengrui.com (email); Hospital Contact, (PI): Caicun Zhou, PhD, at 13301825532 (telephone) or caicunzhoudr@163.com (email)
Location: Shanghai Pulmonary Hospital (Shanghai, China)
Brief Description: This is a Phase I, Dose-escalation/Dose-expansion study to evaluate the safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity of an investigational drug (SY-5933 tablets) in patients with advanced KRAS p.G12C mutant solid tumors. Approximately 50 participants will be enrolled.
Baseline Eligibility Criteria include, but are not limited to:
- No severe gastrointestinal disease of clinical significance as determined by the investigator
- Dose-Escalation Phase:
- Histologically or cytologically confirmed advanced solid tumors harboring the KRAS p.G12C mutation and have progressed after standard therapy, or standard therapy is inappropriate or unavailable.
- At least one assessable lesion per RECIST version 1.1 *
- No known driver alterations other than KRAS p.G12C
- Dose-Expansion Phase [Cohort B]:
- Histologically or cytologically confirmed advanced KRAS p.G12C mutant solid tumors and have progressed after standard therapy, or standard therapy is inappropriate or unavailable
- One measurable lesion per RECIST version 1.1 *
- No prior use of selective KRAS inhibitors
Contact: Study Contact: Yinghui Sun, PhD, at 86-10-88858616 (telephone) or yhsun@centaurusbio.com (email); Hospital Contact: Caicun Zhou, PhD, at 13301825532 (telephone) or caicunzhoudr@163.com (email)
A Phase I Clinical Study of QLC1101 in Patients With Advanced Solid Tumors (NCT06403735)
Location: Sites in Guangdong, Heilongjiang, Jiangxi, Shanghai, and Yunnan, China in various statuses of recruitment. To view specific locations, click here.
Brief Description: This is a Phase I study to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of an investigational drug (QLC1101) in the treatment of patients with advanced solid tumors harboring a KRAS G12D Mutation. Approximately 250 participants will be enrolled.
Baseline Eligibility Criteria include, but are not limited to:
- Histologically confirmed advanced (metastatic or unresectable) solid tumors harboring a KRAS G12D mutation
- Failed or are unable to tolerate standard treatment, lack standard treatment, or refuse to receive standard treatment
- Able to swallow and retain oral medication and must not have any clinically significant gastrointestinal abnormality that may alter absorption
- At least one measurable lesion per the RECIST v1.1 criteria *
- Not previously treated with inhibitors against KRAS G12D mutation
- No clinically significant gastrointestinal disorders or other conditions that seriously interfere with drug absorption
Contact: To view specific contact information for each site, click here.
Clinical Trials Not Yet Recruiting
A Phase I Clinical Study of HRS-7058 in Patients With Advanced Malignant Tumour (NCT06383871) (NOT YET RECRUITING)
Location: No location data yet
Brief Description: This a Phase I study of safety, tolerability, pharmacokinetics, and efficacy of an investigational drug (HRS-7058) in patients with advanced solid tumours with the KRAS G12C mutation. This includes a dose escalation, dose extension, and efficacy extension. Approximately 151 participants will be enrolled.
Baseline Eligibility Criteria include, but are not limited to:
- Subjects with locally advanced or metastatic solid tumour confirmed by histopathology;
- Having at least one evaluable or measurable lesion according to the solid tumour response Evaluation Criteria (RECIST 1.1) *
- Able to ingest drugs
- No refractory nausea, vomiting, or other gastrointestinal disorders that affect the use of oral medications;
Contact: Study Contact: Liang Cao at +0518-81220121 (telephone) or liang.cao@hengrui.com (email); Study Contact Backup: Huan Li at +0518-81220121 (telephone) or huan.li@hengrui.com (email)
Mutant KRAS G12V-specific TCR Transduced T Cell Therapy for Advanced Solid Tumor (NCT05933668) (NOT YET RECRUITING)
Location: Department of GI Oncology, Peking University Cancer Hospital (Beijing, China)
Brief Description: This is a Phase I dose increasing study. The purpose of this study is to evaluate the safety and efficacy of a treatment (YK0901 TCR-T cell immunotherapy) in the treatment of patients with advanced solid tumor whose tumor antigen KRAS G12V expression is positive (HLA-A * 11:01). Approximately 11 participants will be enrolled.
Baseline Eligibility Criteria include, but are not limited to:
- Failure on or intolerance to systemic therapy for unresectable advanced cancer.
- At least one measurable lesion defined by RECIST 1.1 *
- HLA-A * 11:01 and KRAS G12V positive
Contact: Lin Shen, PhD, at (86)10-88196561 (telephone) or linshenpku@163.com (email)
RE002 T Cell Injection for the Treatment of KRAS G12D Mutated Solid Tumors (NCT06546150) (NOT YET RECRUITING)
Location: Henan Cancer Hospital (Zhengzhou, Henan, China)
Brief description: This is a Phase I dose-increasing study of safety and tolerance of a RE002 TCR-T cell treatment. It is planned to recruit 30 patients with advanced malignant solid tumor with KRASG12D mutation.
Baseline Eligibility Criteria include, but are not limited to:
- Advanced malignant solid tumors with clear pathological diagnosis
- Standard therapies failed or cannot be tolerated or lacks effective treatments
- Have at least one measurable lesion *
- HLA-A* 11:01 positive; Tumor gene testing carries KRAS G12V mutation;
- No previous use of drugs targeting KRAS G12V mutations, including previous participation in cell therapy with similar targets Cellular testing and small molecule inhibitors targeting KRAS G12V mutations
- Patients with a previous history of symptomatic brain metastasis and stable symptoms after local treatment were enrolled in the group who did not need antiepileptic drugs and steroids at least 14 days before lymphocyte clearance
- Subjects with asymptomatic brain metastasis without tumor-related brain edema, displacement, steroids or antiepileptic drugs can be enrolled.
Contact: Study Contact: Zi B Wang at +8637165588219 (telephone) or zlyywzb2118@zzu.edu.cn (email)
KRAS and EGFR Mutations
Trials in U.S.
Location: Multiple U.S. sites (CA, FL, OH, TX, and VA). One location in Rio Piedras, Puerto Rico. To view specific locations, click here.
Brief Description: This is a Phase 1 dose escalation study in patients with advanced malignant solid tumors harboring KRAS or EGFR mutations to determine the maximum tolerated dose and recommended Phase II dose of an investigational oral monotherapy (SHP2 Inhibitor: HBI-2376) and characterize its pharmacokinetic profile. Approximately 42 participants will be enrolled.
Baseline Eligibility Criteria include, but are not limited to:
- Advanced malignant solid tumors with KRAS or EGFR mutations diagnosed by histology or cytology
- Relapsed or refractory to, or intolerant of, or refuse approved or standard of care established therapy known to provide clinical benefit for disease
- At least 1 measurable target lesion that meets the definition of RECIST v1.1 *
- Able to swallow oral medications and must not have gastrointestinal abnormalities that significantly affect drug absorption
- No prior treatment with any SHP2 inhibitors
Contact: John Ning, MD, PhD, FAIC, Study Contact, at 858-280-1866 (telephone) or jning@huyabio.com (email); To view specific contact information for each site, click here.
KRAS and Other RAS Mutations
Trials in U.S.
Location: : Multiple U.S. sites (CA, MD, MA, NY, OH, TN, TX, UT, and VA). To view specific sites, click here.
Brief Description: This is a Phase I study of an investigational drug (RMC-6236) in patients with advanced solid tumors harboring specific mutations in RAS. This includes a dose escalation and also finding the maximum tolerable dose and the recommended phase 2 dose. Approximately 474 participants will be enrolled.
Baseline Eligibility Criteria include, but are not limited to:
- Histologically confirmed advanced solid tumor with specific KRAS G12 mutations [Dose Escalation] or RAS mutations [Dose Optimization/Expansion]
- Received prior standard therapy appropriate for tumor type and stage
- No known or suspected impairment of gastrointestinal function that may prohibit ability to swallow or absorb an oral medication
Contact: Revolution Medicines, Inc. at (650) 779-2300 (telephone) or rmc-6236_ct-inquiry@revmed.com (email)
Location: Multiple U.S. sites. To view specific locations, click here.
Brief Description: This is a Phase I study. It includes a dose expansion phase currently evaluating ompenaclid and bevacizumab in combination with FOLFIRI in patients with advanced (i.e., locally advanced and unresectable, or metastatic) previously treated colorectal adenocarcinoma. This trial includes patients with appendiceal adenocarcinoma per note below. A new dose escalation and expansion stage will evaluate ompenaclid in combination with FOLFOX and bevacizumab in patients with metastatic CRC. It is anticipated that a total of 30 patients will be enrolled in this new dose escalation and expansion stage of the study. Approximately 108 participants will be enrolled.
NOTE: “We accept patients with adenocarcinoma of the appendix to the RGX 202-001 study (Conducted in the US) and to the RGX 202 -002 study (Conducted in the EU)” - Clarification provided by Naftali Bechar MD at naftali.bechar@inspirna.com
Baseline Eligibility Criteria include, but are not limited to:
- Histologic or cytologic evidence of a RAS colorectal cancer of adenocarcinoma (or appendiceal adenocarcinoma per note above) or poorly differentiated histology and must have disease that is resistant to or relapsed following available standard systemic therapy or for which there is no standard systemic therapy or reasonable therapy likely to result in clinical benefit or if such therapy has been refused by the patient.
- The patient must have advanced disease, defined as cancer that is either metastatic or locally advanced and unresectable (and for which additional radiation therapy or other locoregional therapies are not considered feasible).
- Pathologically documented adenocarcinoma or poorly differentiated locally advanced/metastatic colorectal cancer
- At least 1 measurable lesion per RECIST version 1.1 *
- No condition that limits swallowing multiple pills or has a history of non-adherence to oral therapies
- No malabsorption condition, such as short bowel syndrome, impaired GI function or GI disease that may significantly alter absorption
- No known DPD deficiency or is on treatment with DPD inhibitors
- [RGX-202-01 plus FOLFIRI and bevacizumab expansion stages]:
- Received only one prior standard of care oxaliplatin-containing regimen for locally advanced/metastatic colorectal cancer
- Must have received prior treatment with pembrolizumab or an FDA approved PD-1/L1 inhibitor as well, if the patient has dMMR/MSI-H colorectal cancer
- May have received prior treatment with bevacizumab, cetuximab, or panitumumab, or an FDA approved biosimilar.
- No known homozygous or heterozygous for UGT1A(1*28, 1*6, or 9*1) ABCG2 allele
- No treatment with strong CYP3A4 inhibitors or strong UGT1A1 inhibitors
- Have not been previously treated with FOLFIRI or other irinotecan regimens
- [FOLFOX/Bevacizumab Combination]
- Must have previously untreated metastatic colorectal adenocarcinoma (or appendiceal adenocarcinoma per above confirmation), defined as cancer that is metastatic and for which additional radiation therapy or other locoregional therapies in curative intent are not considered feasible or beneficial. Note that patients who have had previous systemic anticancer therapy as neoadjuvant or adjuvant therapy and had a metastatic recurrence at least 12 months after the last dose of adjuvant oxaliplatin will also be eligible.
- The patient must have disease that is measurable by standard imaging techniques by RECIST version 1.1 or by physical examination methods (ruler or calipers). For patients with prior radiation therapy, measurable lesions must be outside of any prior radiation field(s), unless disease progression has been documented at that disease site subsequent to radiation. *
Contact: Study Contact: Steve Kaesshaefer at 1-973-715-2917 (telephone) or steve.kaesshaefer@inspirna.com (email); RGX-202 Medical Monitor: Naftali Bechar, MD, Appendix Cancer Clarification Provider, at naftali.bechar@inspirna.com (email); To view specific contact information for each site, click here.
KRAS or BRAF Mutations
Trials in U.S.
Study of IK-595 in RAS- or RAF-altered Advanced Tumors (NCT06270082)
Location: Multiple U.S. sites (MI, PA, TN, TX, and VA). To view specific sites, click here.
Brief Description: This is a Phase 1 Dose Escalation and Dose Expansion study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics effects, and preliminary antitumor activity of an oral investigational drug (IK-595, a MEK/RAF molecular glue) in patients with advanced solid tumors with gene alterations in the RAS- MAPK pathway. Approximately 150 participants will be enrolled.
Baseline Eligibility Criteria include, but are not limited to:
- Able to swallow or retain oral medication.
- Dose Escalation
- Histologically or cytologically confirmed solid tumor malignancies that are advanced and unresectable, or metastatic with no available therapy known to confer clinical benefit. There is no upper limit on the number of prior lines of anticancer therapy received. Tumors must have confirmed RAS/RAF gene alterations
- KRASmut solid tumors
- BRAFmut Class I/II/ III or BRAF fusions solid tumors
- Patients who have measurable or evaluable disease by RECIST 1.1 criteria
- Histologically or cytologically confirmed solid tumor malignancies that are advanced and unresectable, or metastatic with no available therapy known to confer clinical benefit. There is no upper limit on the number of prior lines of anticancer therapy received. Tumors must have confirmed RAS/RAF gene alterations
- Dose Expansion
- Histological diagnosis of an advanced, unresectable, locally recurrent, or metastatic disease with no available therapy known to confer clinical benefit. There is no upper limit on the number of prior lines of anticancer therapy received.
- [Cohort 4]: Any solid tumors with molecularly confirmed pathogenic BRAF non-V600X mutations or fusions
- Histological diagnosis of an advanced, unresectable, locally recurrent, or metastatic disease with no available therapy known to confer clinical benefit. There is no upper limit on the number of prior lines of anticancer therapy received.
- ≥ 1 measurable lesion per RECIST 1.1 criteria as assessed by the Investigator/local radiologist. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions. Exceptionally, patients with tumors that are evaluable but non-measurable per RECIST 1.1 criteria can be enrolled *
Contact: Study Contact: Trupti Lingaraj at 6033618939 (telephone) or tlingaraj@ikenaoncology.com (email); Study Contact Backup: David Damphousse at 617-513-9825 (telephone) or ddamphousse@ikenaoncology.com (email); To view specific contact information for each site, click here.
BRAF
Trials Outside of U.S.
A Phase I Study of HL-085 Plus Vemurafenib in Solid Tumor With BRAF V600 Mutation (NCT03781219)
Location: Multiple sites in Beijing, Henan, and Zhejiang, China. To view specific sites, click here.
Brief Description: This is a Phase I Dose Escalation study to evaluate safety, pharmacokinetics and preliminary efficacy of an investigational drug (HL-085) in combination with vemurafenib in patients with BRAF V600 mutant advanced solid tumors. Approximately 45 participants will be enrolled.
Baseline Eligibility Criteria include, but are not limited to:
- BRAF V600 mutation in solid tumor.
- One measurable lesion as defined by RECIST 1.1 criteria for solid tumors *
- Able to take the medicine orally.
- No prior therapy with MEK-inhibitor.
Contact: Jin Ma, Bachelor at 86 13810268600 (telephone) or maj@kechowpharma.com (email)
Location: Sun Yat-sen University Cancer Center (Guangzhou, China)
Brief Description: This is a Phase I study evaluating the safety, tolerability, pharmacokinetics, and initial efficacy of an investigational drug (HLX208) in combination with trametinib in patients with advanced solid tumors. Approximately 220 participants will be enrolled.
Baseline Eligibility Criteria include, but are not limited to:
- Metastatic/recurrent advanced BRAF+ solid tumors that have been diagnosed histologically and have failed standard treatment
- Previous failure to standard treatment, intolerance to standard treatment, absence of standard treatment, or insuitability for standard treatment at this stage.
- No previous treatment with BRAF inhibitors or MEK inhibitors
Contact: Leading PI: Li Zhang at zhangli@sysucc.org.cn (email); Study Contact Backup: Ye Guo at pattrickguo@gmail.com (email)
Phase I Study of HSK42360 in Solid Tumors With BRAF V600 Mutation (NCT06536400)
Location: Multiple sites in China. To view specific locations, click here.
Brief description: This is a Phase I dose-escalation and expansion study to evaluate the safety, tolerability, PK and PD of HSK42360 when given orally in patients with active BRAF V600 mutation locally advanced or metastatic solid tumors. Approximately 316 participants will be enrolled.
Baseline Eligibility Criteria include, but are not limited to:
- Locally advanced or metastatic solid tumors confirmed by histology or cytology, who have failed standard treatment (disease progression after treatment or intolerable treatment)
- Patients who have previously received BRAF and/or MEK inhibitor therapy are allowed to be included in this study.
- Positive BRAF V600 mutation result confirmed prior to the administration of HSK42360.
- Measurable or non-measurable disease by RECIST 1.1 or RANO criteria.
- Patients with rain metastasis with inactive CNS lesions; Original intracranial tumor patient with inactive CNS lesions, or patients treated with ≤4mg/day corticosteroid and without convulsion for ≥2 weeks are eligible
- No disease which would preclude drug absorption, metabolism or pharmacokinetics, e.g. active peptic ulcer or chronic gastroesophageal reflux disease.
Contact: To view contact information for each site, click here.
PIK3CA
Trials in U.S.
Location: Multiple sites in the U.S., France, Italy, and Spain. To view specific sites, click here.
Brief Description: This is a Phase I study designed to evaluate the maximum tolerated dose, recommended Phase 2 dose, safety, tolerability, PK, pharmacodynamics, and preliminary antineoplastic activity of an investigational drug (RLY-2608), in advanced solid tumor patients with a Phosphatidylinositol-4,5-bisphosphate-3 kinase, catalytic subunit alpha (PIK3CA) mutation in blood and/or tumor. This arm will have 2 parts: a dose escalation (Part 1) and a dose expansion (Part 2). Approximately 400 participants will be enrolled.
Baseline Eligibility Criteria include, but are not limited to:
- One or more documented primary oncogenic PIK3CA mutation(s) in blood and/or tumor
- Other potentially oncogenic PIK3CA mutations may be considered but must be approved by Sponsor
- Disease that is refractory to standard therapy, intolerant to standard therapy, or has declined standard therapy
- No prior treatment with PI3Kα, AKT, or mTOR inhibitors
- Part 1
- Histologically or cytologically confirmed diagnosis of unresectable or metastatic solid tumor
- Evaluable disease per RECIST v1.1 *
- Part 2
- Measurable disease per RECIST v1.1 *
- Unresectable or metastatic solid tumor with PIK3CA mutation(s) and one of the following tumor types:
- Group 4: other solid tumors
- Group 5: unresectable or metastatic solid tumors with PIK3CA double mutations
Contact: Relay Therapeutics Inc at 617-322-0731 (telephone) or ClinicalTrials@relaytx.com (email)
Other Mutations/Characteristics
Trials in U.S.
PAS-004 in Patients With Advanced Solid Tumors (NCT06299839)
Location: NEXT Oncology (Austin, Irving, and San Antonio, TX) (Fairfax, VA)
Brief Description: This is a Phase 1 study to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of an investigational drug (PAS-004) in patients with MAPK pathway-driven advanced solid tumors with a documented RAS, NF1, or RAF mutation or patients who have failed BRAF/MEK inhibition. Approximately 42 participants will be enrolled.
Baseline Eligibility Criteria include, but are not limited to:
- Patient must be able to swallow oral medication
- Patient with histologically or cytologically diagnosed mitogen-activated protein kinase (MAPK) pathway driven advanced solid tumors with all of the following characteristics:
- Tumor cannot be surgically resected
- Patient has failed or is ineligible for standard of care therapy
- Patient has no available treatment options with known clinical benefit
- Documented evidence of rat sarcoma virus (RAS), neurofibromatosis type I (NF1), and/or rapidly accelerated fibrosarcoma (RAF) mutations. Patients with RAF mutations must have previously failed v-Raf murine sarcoma viral oncogene homolog B (BRAF) / MEK inhibition.
- No Active dysphagia, digestive system disease, malabsorption syndrome, or other conditions affecting PAS-004 absorption.
Contact: Austin and Irving Contact: Erica Torres at 210-610-5205 (telephone) or etorres@nextoncology.com (email); San Antonio Contact: Carmen Gonzalez at 210-580-9521 (telephone) or cgonzalez@nextoncology.com (email); VA Contact: Blake Patterson at 703-783-4505 (telephone) or BPatterson@nextoncology.com (email)
JAB-2485 Activity in Adult Patients With Advanced Solid Tumors (NCT05490472)
Location: Multiple sites in the U.S. (Recruiting) and China (Not Yet Recruiting). To view specific sites, click here.
Brief Description: This is a Phase I/IIa study to evaluate the safety and tolerability of an investigational drug (JAB-2485) in adult participants with AT-rich interaction domain 1A (ARID1A) mutant advanced solid tumors. It will determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) during the Dose Escalation phase then further evaluate preliminary antitumor activity at the RP2D in the Dose Expansion phase. Approximately 102 participants will be enrolled.
Baseline Eligibility Criteria include, but are not limited to:
- Histologically or cytologically confirmed metastatic or locally advanced AT-rich interaction domain 1A (ARID1A) mutant solid tumor
- Refractory to or become intolerant of existing therapy(ies) known to provide clinical benefit for their condition
- At least 1 measurable lesion per RECIST v1.1 *
- Able to swallow and retain orally administered medication
Contact: Study Contact: Jacobio Pharmaceuticals at (781) 918-6670 (telephone) or clinicaltrials@jacobiopharma.com (email); Study Contact Backupz: Zhiwen He at Zhiwen.he@jacobiopharma.com (email)
Location: Multiple U.S. sites. To view specific sites, click here.
Brief Description: This is a Phase I/II Dose-Escalation and Dose-Expansion study of an investigational drug (BBI-355) alone and in combinations with erlotinib or futibatinib in subjects with locally advanced or metastatic solid tumors with oncogene amplifications. Approximately 150 participants are enrolled.
Baseline Eligibility Criteria include, but are not limited to:
- Locally advanced or metastatic non-resectable solid tumors, whose disease has progressed despite all standard therapies or for whom no further standard or clinically acceptable therapy exists
- BBI-355 alone arm: Evidence of oncogene amplification
- BBI-355 with Futibatinib arm: Evidence of amplification of wildtype FGFR1-4 and no prior exposure of FGFR inhibitors
- BBI-355 with Erlotinib arm: Evidence of amplification of wildtype EGFR and no prior exposure to EGFR inhibitors
- Measurable disease as defined by RECIST Version 1.1 *
- No well-known tumor activating oncogene mutations or fusions
- No prior exposure to CHK1 inhibitors
Contact: Study Contact: Sara Weymer or Rebecca Reynolds, at 16198211090 (telephone) or ClinicalDevelopment@boundlessbio.com (email)
Combination Therapy in Cancers With Mutations in DNA Repair Genes (NCT05694715)
Location: University of California (San Francisco, California)
Brief Description: This is a Phase Ib dose finding study of niraparib and irinotecan in combination therapy. For this study, individuals with metastatic solid tumor malignancies harboring various mutations (ATM included) will be enrolled with specific tumors of interest including gastrointestinal cancers. It will assess the safety, tolerability, and preliminary efficacy and find the MTD and recommended phase II dose. Approximately 24 participants will be enrolled.
Baseline Eligibility Criteria include, but are not limited to:
- Solid tumors where topoisomerase I inhibitors have shown efficacy, including gastrointestinal tumors with one or more of the following DNA repair defects:
- BRCA1-2, ATM, and/or PALB2
- Presence of at least one lesion with measurable disease as defined by RECIST 1.1 criteria for response assessment *
- Advanced solid tumor malignancy without curative options
- Must be able to take oral medications
- No history of a malabsorption syndrome or uncontrolled nausea, vomiting, or diarrhea that may interfere with the absorption of oral study medication in the opinion of the investigator
- No individuals with homozygous or compound heterozygous UGT1A1 polymorphisms (e.g., alleles *28/*28, *6/*6, or *6/*28) predicted to be associated with medium-to-high risk of irinotecan-related toxicity
Contact: Study Contact: Early Phase Cancer Clinical Trials Recruitment at 877-827-3222 or EarlyPhaseClinicalTrials@ucsf.edu (email); cancertrials@ucsf.edu (email); Principal Investigator: Pamela Munster, MD at Pamela.Munster@ucsf.edu (email)
Location: University of California (San Francisco)
Brief Description: This is a Phase I/Ib study evaluating the combination of Olaparib with an investigational drug (ASTX727). The study population consists of adults with advanced/metastatic solid tumor malignancies with germline or somatic mutations in the HRR pathway, including, but not limited to, the ATM gene. Approximately 18 participants will be enrolled.
Baseline Eligibility Criteria include, but are not limited to:
- Histologically or cytologically confirmed advanced solid tumors (any solid tumor type) with:
- Phase I, Dose Escalation: Germline and/or somatic mutation in ATM
- Phase Ib, Dose Expansion:
- Expansion Cohort A (n=6): Germline mutation (with or without accompanying somatic mutation) in ATM
- Expansion Cohort B (n=6): Germline and/or somatic mutation in ATM,
- Has measurable disease per RECIST 1.1* as assessed by the investigator.
- Participants may have received any lines of prior therapy and is refractory or intolerant to therapy approved for their condition or unwilling to receive currently approved therapy.
- Prior PARP inhibitors are allowed, provided the following two criteria are met:
- Participant has NOT required toxicity related dose reductions or dose delays during prior PARP inhibitor treatment; and
- Participant has NOT experienced any allergic reaction to PARP inhibitors.
- Ability to swallow oral medications
Contact: Study Contact: Early Phase Cancer Clinical Trials at 877-827-3222 (telephone) or EarlyPhaseClinicalTrials@ucsf.edu (email); cancertrials@ucsf.edu (email); Principal Investigator: Pamela Munster, MD
Trials Outside of U.S.
Location: Multiple sites in Australia. To view specific locations, click here.
Brief Description: This is a Phase I study to investigate the safety and efficacy of an oral tablet investigational drug (Pan-RAF/MEK Glue NST-628) in subjects with solid tumors harboring genetic alterations in the MAPK pathway and with other solid tumors. The study includes a dose escalation part followed by a dose expansion. Approximately 230 participants will be enrolled.
Baseline Eligibility Criteria include, but are not limited to:
- Subjects who have a histologically or cytologically documented metastatic or locally advanced solid tumor, for which standard of care (SoC) therapy does not exist, no longer provides benefit, or is not tolerated by the subject, or the subject has been assessed by the Investigator as not being suitable for SoC therapy
- No conditions interfering with oral intake of NST-628
- No conditions interfering with intestinal absorption of an orally administered drug
- No prior treatment with any MEK or BRAF inhibitor
- [Part A]: Any solid tumor with genetic alteration of or evidence of tumor dependence upon the RAS/MAPK pathway (subject to additional restrictions specified in the study protocol)
- [Part B.ii Non-Melanoma Cohort]: Solid tumors with NRAS/KRAS activating mutations and select BRAF alterations
- Measurable disease as defined by RECIST Version 1.1 or by other disease assessment tool standard *
- No prior treatment with any MEK or BRAF inhibitor
Contact: Study Contact: CMO, at 617-468-4292 (telephone) or info@nestedtx.com (email); Study Contact Backup: Ann Marie Kennedy, at 919-427-4225 (telephone) or amkennedy@nestedtx.com (email); To view specific contact information for each site, click here.
Location: Institut Curie (Paris and Saint-Cloud, France)
Brief Description: A Phase I study of Tuvusertib in combination with an investigational drug (PLX038) with dose expansion cohorts in patients with advanced solid tumors. Approximately 92 participants will be enrolled.
Baseline Eligibility Criteria include, but are not limited to:
- Locally advanced or metastatic solid cancer that is not amenable to curative treatment.
- ATM-mutated solid cancers: Inactivating mutation of ATM (presence of truncating mutation or R337/R3008 missense mutation of ATM mono and/or biallelic)
- Measurable disease (per RECIST version 1.1) *
- Received a minimum of one and a maximum of six prior cytotoxic chemotherapy regimens for locally advanced or metastatic cancer.
- No patients with chronic inflammatory bowel disease and/or bowel obstruction.
Contact: Study Contact: Fouzia Azzouz at 0147112366 (telephone) or fouzia.azzouz@curie.fr (email); Study Contact Backup: François-Clément Bidard, Study Principal Investigator, at francois-clement.bidard@curie.fr (email)
Solid Tumors Generally (Appendix cancer, including mucinous, is considered a solid tumor.)
Trials in U.S.
AOH1996 for the Treatment of Refractory Solid Tumors (NCT05227326)
Location: City of Hope Medical Center, Duarte, CaliforniaBrief Description: This phase I trial studies the side effects and best dose of AOH1996 in treating patients with solid tumors that do not respond to treatment (refractory). AOH1996 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Inclusion Criteria:
- Life expectancy of > 3 months
- Concomitant medications/therapies
- Dietary/herbal supplements
- Other investigational products
- Warfarin
- Current or planned use of agents contraindicated for use with strong CYP3A4 inducers
- Strong inhibitors or inducers of CYP2C9
- Strong inhibitors or inducers of CYP3A
- Issues with tolerating oral medication (e.g. inability to swallow pills, malabsorption issues, ongoing nausea or vomiting)
- Women who are or are planning to become pregnant or breastfeed
- Known allergy to any of the components within the study agents and/or their excipients
- No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated Stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for three years
- Intercurrent or historic medical condition that increases subject risk in the opinion of the Investigator. Eligibility may be revisited for intercurrent medical conditions once resolution/recovery is deemed adequate by the investigator (e.g. recovery from major surgery, completion of treatment for severe infection)
- Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)
Location: Multiple sites throughout U.S.
Brief description: This is a Phase 1 study to evaluate the safety and tolerability of an investigational drug, TAK-676 as a single agent and in combination with KEYTRUDA (pembrolizumab). Approximately 76 participants will be enrolled.
Baseline Eligibility Criteria include, but are not limited to:
- Have locally advanced or metastatic solid tumor that has no standard therapeutic options or the patient is intolerable to those standard therapeutic options.
Contact: Takeda (study sponsor) at 1-877-825-3327 (phone) or medinfous@takeda.com OR go to above-referenced NCT link at clinicaltrials.gov and scroll down to the location of interest to view contact information specific to it.
Location: Multiple U.S. sites. To view specific locations, click here.
Brief description: This is a multicenter, open-label, Phase 1 study of orally administered VMD-928 in adult subjects with advanced solid tumors or lymphoma that have progressed or are non responsive to available therapies and for which no standard or available curative therapy exists.
Baseline Eligibility Criteria include, but are not limited to:
- Histologically or cytologically confirmed diagnosis of any type of solid tumor malignancy or lymphoma that is not responsive to standard therapies or had progressed following standard therapy and for which there is no approved or curative therapy. Additionally, patients must not be candidates for or have exhausted regimens known to provide clinical benefit, including hematopoietic stem cell transplantation in lymphoma patients if they are deemed transplant eligible.
- Able to swallow and retain oral medication.
- Subjects must either have available archival tumor tissue samples, or consent to tumor tissue sampling prior to the first dose, that is sufficient for IHC analysis of TrkA expression, except with prior documented NTRK+.
- Subjects must have a tumor:
- Adequate organ system function as defined as follows:
- Absolute neutrophil count ≥1.5x10^9/L
- Hemoglobin ≥9g/dL
- Platelets ≥100x10^9/L
- PT/INR, PTT ≤1.5xULN
- Total bilirubin ≤1.5x ULN
- AST, ALT ≤2.5xULN
- Creatinine ≤1.2xULN for age, weight
- Calculated creatinine clearance or 24h urine creatinine clearance ≥60mL/min
Location: Participating sites throughout the U.S. (CT, FL, KY, MA, NE, NJ, PA, TN, TX). To view the specific sites and contact information for each of those sites, please click on the NCT identifier listed above for this trial and go to “Locations” heading.
Brief description: This is a Phase 1 dose escalation and expansion study to determine the safety, tolerability and recommended Phase 2 dose of TTX-080 alone (HLA-G inhibitor) and in combination with either pembrolizumab (PD-1 inhibitor) or cetuximab (EGFR inhibitor) in patients with advanced refractory/resistant solid tumors. This study will enroll approximately 200 patients.
Baseline Eligibility Criteria include, but are not limited to:
- Diagnosis of advanced/metastatic cancer
- Must not have a history of severe autoimmune disease.
Temporarily Suspended
Trials in U.S.
Location: Multiple U.S. locations (AZ, CA, MA, TX). To view specific sites and contact information, click on the above listed NCT, then scroll down to “Location” tab.
Brief description: This is a Phase 1 study that will include a dose escalation and a dose expansion phase. There will be 3 separate groups of patients enrolled, one of which includes patients with a BRAF V600-mutated metastatic solid tumor. Approximately 42 patients are expected to be enrolled in the JSI-1187 monotherapy dose-escalation phase, 24 patients are expected to be enrolled in the JSI-1187 plus dabrafenib dose-escalation phase, and a total of 58 patients are expected to be enrolled in the JSI-1187 plus dabrafenib expansion phase..
Baseline Eligibility Criteria include, but are not limited to:
- For JSI-1187 monotherapy dose escalation phase, a confirmed MAPK pathway mutation, including, e.g., BRAF, MEK, RAS-GAP, RAS-GEF, refractory to or relapsed on prior therapy, and have received all available therapy known to confer clinical benefit.
- For JSI-1187 plus dabrafenib combination dose escalation phase, a confirmed BRAF V600-mutated locally advanced or metastatic solid tumor, refractory to, or relapsed on, prior therapy, and have received all available therapy known to confer clinical benefit.
- For JSI-1187 plus dabrafenib expansion phase, BRAF V600E solid tumor cohort, must have a BRAF V600 mutated metastatic solid tumor, after 1 or 2 therapies.
- Must not have gastrointestinal (GI) conditions that could impair absorption of study drug(s)
- Must be able to swallow and retain orally-administered medication and not have any clinically significant gastrointestinal abnormalities that may alter absorption such as malabsorption syndrome or major resection of the stomach or bowels.
Contact: Contact persons listed for specific site of interest (found under the Locations tab for this trial), OR can also contact: Georgine Price (tel. 301-610-4990; e-mail – georgineprice@westat.com) or Marsha Johnson (tel. 202-669-2954; e-mail marshajohnson@westat.com))
PHASE 1/2 CLINICAL TRIALS
Appendix Cancer-Specific
Trials in U.S.
A Study to Investigate APL-5125 in Adults With Advanced Solid Tumors (NCT06399757)
Location: N/A
Brief description: This is a Phase I/II study to determine the safety, tolerability, and efficacy of an investigational drug (APL-5125) for the treatment of selected locally advanced or metastatic solid tumors with particular focus on Colorectal carcinoma. Approximately 100 participants will be enrolled.
Baseline Eligibility Criteria include, but are not limited to:
- Histologically confirmed locally advanced, inoperable, or metastatic tumor; Colorectal carcinoma, Cholangiocarcinoma, Appendiceal adenocarcinoma.
- [Phase 1 sub-studies]: Appendiceal adenocarcinoma, etc.
- [Phase 2]: Colorectal carcinoma
- No available standard of care therapy or participant is ineligible for standard of care therapy
Contact: Apollo Therapeutics at 781-479-226 (telephone) or AP10@apollotx.com (email)
Location: MD Anderson Cancer Center, Houston, Texas.
Brief description: To find the recommended dose of the drug paclitaxel that can be given intraperitoneally (given directly into the abdominal cavity) to participants with metastatic appendiceal adenocarcinoma.
Baseline Eligibility Criteria include, but are not limited to:
- Participants must have histologically confirmed diagnosis of unresectable locally metastatic appendiceal adenocarcinoma
- Metastatic disease in the peritoneal cavity and not a candidate for cytoreductive surgery
- Participants with metastases outside the peritoneal cavity are not eligible for enrollment
Contact Person(s): Beth Helmink, MD, (832) 696-5784, bhelmink@mdanderson.org
Specific Tumor Mutations/Characteristics
TP53
Trials in U.S.
JAB-30355 in Patients With Advanced Solid Tumors Harboring TP53 Y220C Mutation (NCT06386146)
Location: Multiples sites in the U.S. and China. To view specific locations, click here.
Brief Description: This is Phase I/IIa study to evaluate the safety, tolerability, pharmacokinetics, and preliminary evidence of antitumor activity of an investigational drug (JAB-30355) in adult patients with advanced solid tumors harboring TP53 Y220C mutation. This study consists of two parts: Dose Escalation Phase (Phase 1) and Dose Expansion Phase (Phase 2a). Approximately 144 participants will be enrolled.
Baseline Eligibility Criteria include, but are not limited to:
- Has been treated with at least one line of systemic therapy for that tumor type and stage.
- Documentation of confirmed TP53 Y220C mutation
- At least 1 measurable lesion per RECIST v1.1 *
- Able to swallow and retain orally administered medication
Contact: Study Contact: Jacobio Pharmaceuticals at 781-918-6670 (telephone) or clinicaltrials@jacobiopharma.com
Location: Multiple sites in the U.S. and other countries. To view specific sites, click here.
Brief Description: This is a Phase I/II study to assess the safety, tolerability, pharmacokinetics, and efficacy of an investigational drug (PC14586 (rezatapopt)) alone and in combination with pembrolizumab in patients with locally advanced or metastatic solid tumors harboring a TP53 Y220C mutation (PYNNACLE). Approximately 230 participants will be enrolled. The Phase 1 goal is to find the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of PC14586 (rezatapopt). The Phase 1b goal is to establish the MTD/RP2D of PC14586 (rezatapopt) when administered in combination with pembrolizumab. Finally, the Phase 2 goal is to evaluate the efficacy of PC14586 (rezatapopt) at the RP2D
Baseline Eligibility Criteria include, but are not limited to:
- Advanced solid malignancy with a TP53 Y220C mutation
- Previously treated with one or more lines of anticancer therapy and progressive disease
- No history of gastrointestinal (GI) disease that may interfere with absorption of study drug or patients unable to take oral medication
- Phase 1b (PC14586 (INN: rezatapopt) + pembrolizumab)
- Anti-PD-1/PD-L1 naive or must have progressed on treatment
- Measurable disease *
- Not received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor and discontinued from that treatment due to a Grade 3 or higher immune-related AE (irAE)
- Not previously received PC14586 (rezatapopt)
- Phase 2 (PC14586 monotherapy)
- Measurable disease per RECIST v1.1 *
- No known KRAS mutation, defined as a single nucleotide variant
Contact: PMV Pharma Clinical Study Information Center at (609) 235-4038 (telephone) or clinicaltrials@pmvpharma.com (emails); To view specific contact information for each site, click here.
KRAS
Trials in U.S.
Location: National Institutes of Health Clinical Center (Bethesda, Maryland)
Brief Description: This is a Phase I/II study of peripheral blood lymphocytes (PBL) transduced with anti-KRAS G12D murine T-cell receptors (TCR) in HLA-A*11:01 positive patients with advanced solid tumors expressing G12D mutated RAS. Phase I: Determine the safety of administering PBL transduced with anti-KRAS G12D mTCR in concert with preparative lymphodepletion and high-dose interleukin-2 (IL-2; aldesleukin). Phase II: Determine if anti-KRAS G12D mTCR-transduced PBL can mediate the regression of tumors harboring the RAS G12D mutation. Approximately 70 participants will be enrolled.
Baseline Eligibility Criteria include, but are not limited to:
- HLA-A*11:01 positive
- Measurable (per RECIST v1.1 criteria), metastatic, or unresectable malignancy expressing G12D mutated (K/N/H)RAS which has progressed after standard therapy (if available) *
- Previously received standard systemic therapy for their advanced cancer and have been either non-responders or have recurred or declined standard treatment.
- Not receiving any other investigational agents.
Contact: NCI SB Immunotherapy Recruitment Center at (866) 820-4505 (telephone) or irc@nih.gov (email); Study Contact Backup: James C Yang, M.D., at (240) 760-6223 (telephone) or jamesyang@mail.nih.gov (email)
Location: Mayo Clinic: Not Recruiting (Jacksonville, FL and Phoenix & Scottsdale, AZ); University of Utah: Recruiting (Salt Lake City, UT)
Brief Description: A Phase I/II study to evaluate the safety and tolerability of an investigational drug (KRAS G12C inhibitor: JAB-21822) alone to determine the Maximum Tolerable Dose and the Recommended Phase 2 Dose during the Dose Escalation phase along with the preliminary antitumor activity. This drug will then be administered in combination with cetuximab during the Dose Expansion phase in adult participants with advanced solid tumors harboring KRAS G12C mutation. Approximately 100 participants will be enrolled.
Baseline Eligibility Criteria include, but are not limited to:
- Histologically or cytologically confirmed solid tumors with KRAS G12C mutation
- At least 1 prior standard therapy
- At least 1 measurable lesion per RECIST v1.1 *
- Be able to swallow and retain orally administered medication
Contact: Study Contact: Huiqiang Wang, PhD, at 86 10 56315466 (telephone) or Huiqiang.wang@jacobiopharma.com (email); Study Contact Backup: Ramina Mikailova at ramina.mikailova@jacobiopharma.com (email)
Location: South TX Accelerated Research Therapeutics (San Antonio, TX); START Mountain Region (West Valley City, UT); VA Cancer Specialists (Fairfax, VA)
Brief Description: This is a Phase I/II Dose Escalation, Dose Expansion and Cohort Expansion study evaluating the safety and activity of an investigational drug (FMC-376) in participants with KRAS G12C mutated locally advanced unresectable or metastatic solid tumors. Approximately 403 participants will be enrolled.
Baseline Eligibility Criteria include, but are not limited to:
- Histologically or cytologically confirmed locally advanced unresectable or metastatic solid tumors with KRAS G12C mutation
- Received and progressed or been intolerant to prior standard therapy OR standard therapy is considered inappropriate OR an investigational agent is considered standard of care
- Must not be a participant in another interventional study while receiving study drug
- No condition that would interfere with study drug absorption
Contact: Study Contact: Andrew Krivoshik, MD, PhD, at +1 (650) 457-1005 (telephone) or andrew.krivoshik@frontiermeds.com (email); To view specific contact information for each site, click here.
Location: MD Anderson Cancer Center (Houston, TX); NEXT Oncology (San Antonio, TX); NEXT Virginia (Fairfax, VA)
Brief Description: The is a Phase I/II study with a phase 1 dose escalation part and phase 2 dose expansion part. It will assess an investigational drug (TSN1611) in subjects with KRAS G12D mutant advanced solid tumors. Approximately 150 participants will be enrolled.
Baseline Eligibility Criteria include, but are not limited to:
- Subjects with histologically or cytologically confirmed locally advanced or metastatic solid tumor harboring KRAS G12D mutation; subjects must be refractory or intolerable to standard treatment, or have no standard treatment available, etc.
- No prior treatment with KRAS G12D targeted therapy.
Contact: Study Contact: Tyligand Clinical Trial Info at at +86 021-50720081 (telephone) or clinical_trial@tyligand.com (email); Study Official: Cindy Li, at li_jing_cindy@tyligand.com (email); To view specific contact information for each site, click here.
A Phase 1/2 Study of MRTX0902 in Solid Tumors With Mutations in the KRAS MAPK Pathway (NCT05578092)
Location: Multiple U.S. sites (CA, CT, MD, OH, OR, TN, TX, VA, and WA). One location in Rio Piedras, Puerto Rico. To view specific locations, click here.
Brief Description: This is a Phase I/II, evaluating the safety and anti-tumor activity of an investigational drug (MRTX0902) alone and in combination with adagrasib ((MRTX849) in patients with advanced solid tumor malignancy harboring mutations in the KRAS-MAPK pathways. Approximately 228 participants will be enrolled.
Baseline Eligibility Criteria include, but are not limited to:
- Histologically confirmed diagnosis of a solid tumor malignancy with any of the following oncogenic mutations
- [MRTX0902 monotherapy]: known KRAS mutations, known annotated recurrent activating SOS1, PTPN11, class III BRAF, or EGFR mutation, or known annotated recurrent inactivating NF1 mutation;
- [MRTX0902 and adagrasib combination therapy]: KRAS G12C mutation.
- Unresectable or metastatic disease
- No available treatment with curative intent; standard treatment is not available or patient declines
- [Phase 1 Dose Escalation]: RECIST 1.1 measurable or evaluable disease *
- [Phase 1b and Phase 2 Cohorts]: RECIST 1.1 measurable disease * AND no prior treatment with a KRAS G12C inhibitor
- Presence of a tumor lesion amenable to mandatory biopsy for pharmacodynamic evaluation at baseline and on-study unless sponsor-confirmed as medically unsafe or infeasible.
- No history of intestinal disease, inflammatory bowel disease, major gastric surgery, or other gastrointestinal conditions likely to alter absorption of study treatment or result in inability to swallow oral medications
Contact: Study Contact: Mirati Therapeutics Study Locator Services, at 1-844-893-5530 (telephone) or miratistudylocator@careboxhealth.com (email); To view specific contact information for each site, click here.
Location: Multiple locations in U.S. and other countries. To view specific locations, click here.
Brief Description: This is a Phase Ib/II study, evaluating the safety and efficacy of sotorasib alone and in combination with other anti-cancer therapies (Click here, and scroll to the Intervention/Treatment section) in subjects with advanced solid tumors with KRAS p.G12C Mutation. Approximately 1126 participants will be enrolled.
Baseline Eligibility Criteria include, but are not limited to:
- Pathologically documented, locally-advanced or metastatic malignancy with, KRAS p.G12C mutation identified through molecular testing
- No gastrointestinal (GI) tract disease causing the inability to take oral medication.
Contact: Study Contact: Amgen Call Center at 866-572-6436 (telephone) or medinfo@amgen.com
Location: Multiple locations in U.S. and other countries. To view specific locations, click here.
Brief Description: This is a Phase Ib/II study, evaluating the safety and efficacy of sotorasib alone and in combination with other anti-cancer therapies (Click here, and scroll to the Intervention/Treatment section) in subjects with advanced solid tumors with KRAS p.G12C Mutation. Approximately 1126 participants will be enrolled.
Baseline Eligibility Criteria include, but are not limited to:
- Pathologically documented, locally-advanced or metastatic malignancy with, KRAS p.G12C mutation identified through molecular testing
- No gastrointestinal (GI) tract disease causing the inability to take oral medication.
Contact: Study Contact: Amgen Call Center at 866-572-6436 (telephone) or medinfo@amgen.com (email)
Study of LY3537982 in Cancer Patients With a Specific Genetic Mutation (KRAS G12C) (NCT04956640)
Location: Multiple sites in the U.S., Australia, Canada, France, Japan, and South Korea. To view specific locations, click here.
Brief Description: This is a Phase I/II study to evaluate safety, tolerability, and preliminary efficacy of an oral investigational drug (LY3537982) in patients with KRAS G12C-mutant advanced solid tumors. This includes: Phase 1a dose escalation, Phase 1b dose expansion and dose optimization, and Phase 2. Approximately 550 participants will be enrolled.
Baseline Eligibility Criteria include, but are not limited to:
- Measurable disease per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) *
- Disease with evidence of KRAS G12C mutation in tumor tissue or circulating tumor DNA
- Histological or a cytologically proven diagnosis of locally advanced, unresectable, and/or metastatic cancer and meet cohort-specific criteria.
- Able to swallow capsule/tablet.
- No disease suitable for local therapy administered with curative intent.
- No prior treatment with any KRAS G12C small molecule inhibitor, except in certain scenarios where such prior therapy is allowed as per protocol
Contact: Patient Advocacy at 855-569-6305 (telephone) or clinicaltrials@loxooncology.com (email); To view specific contact information at each site, click here.
Location: Multiple sites in the U.S., Australia, China, and South Korea. To view specific locations, click here.
Brief Description: This is a Phase I/II Dose-escalation and Dose-expansion study, evaluating the safety and efficacy of an investigational drug (D3S 001) alone or combination therapy with other investigational drugs (Pembrolizumab; Cisplatin; Carboplatin; Pemetrexed; Cetuximab) in subjects with advanced solid tumors with a KRAS p.G12C mutation. Approximately 352 participants will be enrolled.
Baseline Eligibility Criteria include, but are not limited to:
- Histologically or cytologically confirmed metastatic or locally advanced solid tumor which is progressing.
- Subject must have measurable disease per RECIST v1.1 *
- No active gastrointestinal disease or other that could interfere significantly with the absorption, distribution, metabolism, or excretion of oral therapy.
- No concurrent participation in any clinical research study involving treatment with any investigational drug, radiotherapy, or surgery, except for the nontreatment phases of these studies (e.g., follow-up phase).
Contact: Medical Director of D3 Bio Investigative Site at +86 21 61635900 (telephone) or D3bio_CT@d3bio.com (email)
Location: Multiple locations in U.S. and other countries. To view specific locations, click here.
Brief Description: This is a Phase Ib/II study, evaluating the safety and efficacy of sotorasib alone and in combination with other anti-cancer therapies (Click here, and scroll to the Intervention/Treatment section) in subjects with advanced solid tumors with KRAS p.G12C Mutation. Approximately 1126 participants will be enrolled.
Baseline Eligibility Criteria include, but are not limited to:
- Pathologically documented, locally-advanced or metastatic malignancy with, KRAS p.G12C mutation identified through molecular testing
- No gastrointestinal (GI) tract disease causing the inability to take oral medication.
Contact: Study Contact: Amgen Call Center at 866-572-6436 (telephone) or medinfo@amgen.com (email)
A Phase 1/2 Multiple Expansion Cohort Trial of MRTX849 in Patients With Advanced Solid Tumors With KRAS G12C Mutation KRYSTAL-1 (NCT03785249)
Location: Multiple sites in the US. One location in San Juan, Puerto Rico. To view specific locations, click here.
Brief Description: A Phase I/II multiple expansion cohort study of adagrasib (MRTX849) in patients with advanced solid tumors with KRAS G12C Mutation KRYSTAL-1. Approximately 822 participants will be enrolled. It will also be used in combination with other anticancer treatments (Pembrolizumab; Cetuximab; Afatinib).
Baseline Eligibility Criteria include, but are not limited to:
- Histologically confirmed diagnosis of a solid tumor malignancy with KRAS G12C mutation
- Unresectable or metastatic disease
- Standard treatment is not available or patient declines
- No history of intestinal disease or major gastric surgery or inability to swallow oral medications
Contact: Mirati Therapeutics Study Locator Services at 1-844-893-5530 (telephone) or miratistudylocator@emergingmed.com (email)
Trials Outside of U.S.
A Study of ZG2001 in Participants With KRAS Mutated Advanced Solid Tumours (NCT06237413)
Location: Chinese PLA General Hospital (Beijing, China)
Brief Description: A Phase I/II Dose escalation study to evaluate the tolerability, safety, efficacy, and pharmacokinetics of an investigational drug (ZG2001 Tosilate Tablets) in participants with KRAS mutated advanced solid tumours. Approximately 110 participants will be enrolled.
Baseline Eligibility Criteria include, but are not limited to:
- Participants with a KRAS mutant solid tumor should have progressed on or are ineligible for all therapy(ies) known to confer clinical benefit.
- Have not received any SOS1 inhibitors;
Contact: Study Contact: Cheng Wei, at +86-0512-57309965 (telephone) or weic@zelgen.com (email); Hospital Contact: Jianming Xu at jmxu2003@163.com (email)
A Study of ZG19018 in Patients With KRAS G12C Mutant Advanced Solid Tumors (NCT06237400)
Location: Chinese PLA General Hospital (Beijing, China)
Brief Description: A Phase I/II Dose Escalation and Expansion Study to evaluate the tolerability, safety, efficacy, and pharmacokinetics of an investigational drug (ZG19018) in patients with KRAS G12C mutant advanced solid tumors. Approximately 110 participants will be enrolled.
Baseline Eligibility Criteria include, but are not limited to:
- Have not received any treatment with inhibitors against KRAS G12C mutation at any time
Contact: Study Contact: Cheng Wei at +86-0512-57309965 (telephone) or weic@zelgen.com (email); Hospital Contact: Jianming Xu at jmxu2003@163.com (email)
A Study to Evaluate the Safety and Efficacy of D-1553 Combined With IN10018 in KRAS G12C Mutant Solid Tumors (NCT06166836)
Location: Multiple sites in China. To view specific locations, click here.
Brief Description: A Phase 1b/II study to evaluate the safety, tolerability, pharmacokinetics and efficacy of an investigational drug (D-1553) combined with ifebemtinib (IN10018)) in subjects with locally advanced or metastatic solid tumors with KRAS G12C mutation. This includes 2 phases: Phase Ib-Dose Escalation and Phase II-Dose Expansion. Approximately 140 participants will be enrolled.
Baseline Eligibility Criteria include, but are not limited to:
- Subjects with pathologically confirmed locally advanced or metastatic solid tumors.
- Confirmed positive KRAS G12C mutation in tumor tissue or other biospecimens (only for phase1b) containing cancer cells or DNA
- [Phase 1b]: subjects with locally advanced or metastatic solid tumors who have progressed on or failed in standard therapy, and no standard treatment is available
- [Phase II; Cohort C]: subjects with other locally advanced or metastatic solid tumors
- Has measurable lesions at baseline according to RECIST 1.1 criteria *
- No prior KRAS G12C inhibitors treatment
Contact: Study Contact: Shu Fang at 86-15933968623 (telephone) or shu.fang@inxmed.com (email); Study Contact Backup: Lily Li at 86-13911551669 (telephone) or lily.li@inxmed.com (email); To view specific contact information for each site, click here.
Location: Multiple sites in China
Brief Description: This is a Phase I/IIa study to evaluate the safety, tolerability, pharmacokinetics and antitumor activity of an investigational drug (JAB-21822) in combination with another investigational drug (JAB-3312) in patients with advanced solid tumors harboring KRAS p.G12C mutation. This involves dose escalation, dose expansion, and finding the recommended phase 2 dose. Approximately 124 participants will be enrolled.
Baseline Eligibility Criteria include, but are not limited to:
- Histologically or cytologically confirmed locally advanced or metastatic advanced solid tumors who have failed or lack standard-of-care (SOC) or are unwilling to undergo or intolerant to SOC; those with solid tumors harboring KRAS p.G12C mutation are preferred
- At least one measurable lesion as defined by RECIST v1.1. If no measurable lesion untreated with radiation is selected as the target lesion, a lesion treated with radiation ≥ 4 weeks before the first dose and with progression conformed by radiography may be selected as the target lesion *
- Able to swallow oral medications without gastrointestinal abnormalities that significantly affect drug absorption
Contact: Jacobio Pharmaceuticals at 86 10 56315466 (telephone) or clinicaltrials@jacobiopharma.com (email)
Contact: Study Contact: Shu Fang at 86-15933968623 (telephone) or shu.fang@inxmed.com (email); Study Contact Backup: Lily Li at 86-13911551669 (telephone) or lily.li@inxmed.com (email); To view specific contact information for each site, click here.
A Study of GFH375 in Patients With Advanced Solid Tumors With KRAS G12D Mutations (NCT06500676)
Location: Shanghai Chest Hospital (Shanghai, China)
Brief Description: This is a Phase I/II study to explore the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of an investigational drug (GFH375) in patients with advanced solid tumors harboring a KRAS G12D mutation. Approximately 290 participants will be enrolled.
Baseline Eligibility Criteria include, but are not limited to:
- With histologically or cytologically confirmed advanced or metastatic solid tumors harboring KRAS G12D mutation
- Have at least one measurable lesion according to RECIST1.1, and the phase Ia allows no measurable lesion *
- No prior treatment with a KRAS G12D inhibitor
Contact: Study Contact: Yolanda Zeng at +86 21 6882 1388 (telephone) or yaozeng@genfleet.com (email); Hospital Contact: Shun Lu, MD
Clinical Trials Not Yet Recruiting
GH21 Combined With D-1553 in KRAS G12C Mutant Advanced Solid Tumors (NCT06435455) (NOT YET RECRUITING)
Location: No location data yet.
Brief Description: This is a Phase Ib/II study to evaluate the safety, tolerability, pharmacokinetics, and efficacy of an investigational capsule drug (GH21) combined with another investigational drug tablet (D-1553) in patients with advanced or metastatic solid tumors harboring KRAS G12C mutation. This study includes 2 parts: dose escalation(Phase Ib) and dose expansion (Phase II) finding and evaluating the recommended phase II dose. Approximately 126 participants will be enrolled.
Baseline Eligibility Criteria include, but are not limited to:
- KRAS G12C mutant advanced solid tumor;
- At least one measurable lesion as defined by RECIST 1.1 *
Contact: Study Contact: Jieqi Tang, bachelor at +8613311557758 (telephone) or tangjieqi@genhousebio.com (email); Study Contact Backup: Zhengbo Song, Doctorate at +8613857153345 (telephone) or zjccgcp_phase1@126.com (email)
GH21 Combined With D-1553 in KRAS G12C Mutant Advanced Solid Tumors (NCT06435455) (NOT YET RECRUITING)
Location: No location data yet.
Brief Description: This is a Phase Ib/II study to evaluate the safety, tolerability, pharmacokinetics, and efficacy of an investigational capsule drug (GH21) combined with another investigational drug tablet (D-1553) in patients with advanced or metastatic solid tumors harboring KRAS G12C mutation. This study includes 2 parts: dose escalation(Phase Ib) and dose expansion (Phase II) finding and evaluating the recommended phase II dose. Approximately 126 participants will be enrolled.
Baseline Eligibility Criteria include, but are not limited to:
- KRAS G12C mutant advanced solid tumor;
- At least one measurable lesion as defined by RECIST 1.1 *
Contact: Study Contact: Jieqi Tang, bachelor at +8613311557758 (telephone) or tangjieqi@genhousebio.com (email); Study Contact Backup: Zhengbo Song, Doctorate at +8613857153345 (telephone) or zjccgcp_phase1@126.com (email)
KRAS and BRAF mutations
Trials in U.S.
Location: Multiple U.S. sites (CA, CO, FL, TN, TX, VA). To view specific locations, click here.
Brief Description: This is a Phase I/II study to evaluate an investigational drug (DCC-3084) alone or in combination with other cancer therapies in participants with advanced cancers. Module A will enroll participants with solid tumors. Each module will be conducted in two parts. Approximately 140 participants will be enrolled.
Baseline Eligibility Criteria include, but are not limited to:
- Able to take oral medication
- No prior treatment with certain BRAF dimer inhibitors
- No malabsorption syndrome or other illness that could affect oral absorption
- ModA Part 1: Dose Escalation Phase
- Pathologically confirmed diagnosis of solid cancer and documentation of Kirsten rat sarcoma (KRAS) or v-raf murine sarcoma viral oncogene homolog B1 (BRAF) mutation
- Exhausted all available standard of care therapies that are known to provide benefit for the participant's condition
- ModA Part 2: Dose Expansion Phase
- Documented BRAF gene mutation
- Pathologically confirmed diagnosis with PD after at least one prior line of therapy in the advanced or metastatic setting
- No known co-occurring mutation of KRAS, HRAS, NRAS, NF1, epidermal growth factor receptor, PI3KCA, or PTEN
Contact: Clinical Team at 785-830-2100 (telephone) or clinicaltrials@deciphera.com (email); To view specific contact information for each site, click here.
K or N/RAS Mutations
Trials in U.S.
Location: Virginia Commonwealth University Massey Cancer Center, Richmond, Virginia.
Brief description: This is a Phase 1/2 clinical study to determine the recommended phase 2 dose of neratinib (brand name NERLYNX) and sodium valproate when given in combination to patients with advanced solid tumors in 28-day cycles. The Phase 2 portion of the study will evaluate the combination at the recommended dose in 3 cohorts of RAS-mutated tumors: KRAS mutant colorectal cancer, KRAS mutant pancreatic cancer, and K or N RAS mutant solid tumors. Approximately 81 participants will be enrolled.
Baseline Eligibility Criteria include, but are not limited to:
- advanced K or N-RAS mutant tumor that has progressed during or after treatment with approved therapies or for which there is no standard effective therapy available
- able to swallow oral medication
- no prior therapy with neratinib
- no uncontrolled diarrhea leading to dehydration or electrolyte disturbances not easily controlled with oral repletion
- no known or suspected malabsorption condition or obstruction
Contact Person: Dr. Andrew Poklepovic at 804-628-2321 (tel.) or Andrew.poklepovic@vcuhealth.org (e-mail); Massey SIIT Team at 804-628-9238 (tel.) or masseysiit@vcu.edu (e-mail); Kristen Bodine, RN at 804-628-5273 (tel.) or klbodine@vcu.edu (e-mail)
RAS and RAF Mutations
Trials in U.S.
A Study of IMM-6-415 in RAS/RAF Mutant Solid Tumors (NCT06208124)
Location: Multiple U.S. sites (AZ, CA, CO, MA, and TX) in various recruitment statuses. To view specific locations, click here.
Brief Description: This is a phase I/IIa study to characterize the safety, tolerability, optimal dose and preliminary anti-tumor activity of an investigational drug (IMM-6-415) in participants with advanced or metastatic solid tumors harboring RAS or RAF oncogenic mutations. Phase I dose escalation will find the recommended Phase 2 dose and phase 2a will include a dose expansion. Approximately 240 participants will be enrolled.
Baseline Eligibility Criteria include, but are not limited to:
-
- [Part 1]: Histologically or cytologically confirmed diagnosis of a locally advanced unresectable or metastatic solid tumor malignancy harboring RAS (NRAS, KRAS, or HRAS)- or RAF- (ARAF, BRAF, RAF1) activating mutations
- [Part 2]: Histologically or cytologically confirmed diagnosis of one of the following locally advanced unresectable or metastatic solid tumor malignancies: …. other RAS-mutated GI cancers (aside from CRC) or any other RAF-mutated solid tumor
- Please note for Part 2, there could be future protocol changes that may impact tumor types allowed
- Received at least 1 line of systemic standard-of-care treatment for their advanced or metastatic disease and in the assessment of the Investigator, would be unlikely to tolerate or derive clinically meaningful benefit from other treatment options
- KRASG12C mutant participants must have received prior treatment with a KRASG12C inhibitor for any approved indication
- Measurable disease (i.e., at least 1 target lesion) according to RECIST 1.1 criteria *
- Ability to swallow oral medications.
Contact: Study Contact: IMM-6-415 Study Team at (860) 321-1302 or clinicaltrials@immuneering.com (email); To view specific contact information for each site, click here.
Other Mutations/Characteristics
Trials in U.S.
JAB-2485 Activity in Adult Patients With Advanced Solid Tumors (NCT05490472)
Location: Multiple sites in the U.S. (Recruiting) and China (Not Yet Recruiting). To view specific sites, click here.
Brief Description: This is a Phase I/IIa study to evaluate the safety and tolerability of an investigational drug (JAB-2485) in adult participants with AT-rich interaction domain 1A (ARID1A) mutant advanced solid tumors. It will determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) during the Dose Escalation phase then further evaluate preliminary antitumor activity at the RP2D in the Dose Expansion phase. Approximately 102 participants will be enrolled.
Baseline Eligibility Criteria include, but are not limited to:
- Histologically or cytologically confirmed metastatic or locally advanced AT-rich interaction domain 1A (ARID1A) mutant solid tumor
- Refractory to or become intolerant of existing therapy(ies) known to provide clinical benefit for their condition
- At least 1 measurable lesion per RECIST v1.1 *
- Able to swallow and retain orally administered medication
Contact: Study Contact: Jacobio Pharmaceuticals at (781) 918-6670 (telephone) or clinicaltrials@jacobiopharma.com (email); Study Contact Backupz: Zhiwen He at Zhiwen.he@jacobiopharma.com (email)
Location: Multiple locations in U.S.
Brief Description: This is a Phase 1/2 study of an investigational drug (APL-101, a c-MET inhibitor) in patients with c-MET dysregulation advanced solid tumors. Approximately 145 participants will be enrolled.
Baseline Eligibility Criteria include, but are not limited to:
- histologically and/or cytological confirmed locally advanced, recurrent or relapsed or metastatic incurable solid malignancy
- tumor with c-Met high amplification or c-Met fusions
- local/archival result (tissue and/or plasma) of a positive c-Met dysregulation
- must not have known mutation/gene rearrangement of EGFR, ALK, ROS1, RET, NTRK, KRAS, BRAF or other driver mutation/gene rearrangement apart from MET
- impairment of GI function or GI disease that may significantly alter drug absorption (e.g., Crohn’s, ulcerative colitis, active inflammatory bowel disease, uncontrolled nausea, vomiting, diarrhea, or malabsorption syndrome)
Contact: Lynn Manlapaz-Espiritu 650-209-4055 (phone) or Lenilyn.Espiritu@apollomicsinc.com (email), or Gavin Choy, 650-209-4055 (phone) or gavin.choy@apollomicsinc.com (e-mail)
Location: Multiple locations in U.S., as well as Australia, Singapore and Korea
Brief Description: This is a Phase 1/2 study of an investigational drug, repotrectinib (TPX-0005), in patients with locally advanced or metastatic solid tumor that harbors an ALK, ROS1, NTRK1, NTRK2, or NTRK3 gene rearrangement by protocol-specified tests. Approximately 450 participants will be enrolled.
Baseline Eligibility Criteria include, but are not limited to:
- cocumented ROS1, ALK or NTRK1-3 gene fusion that has been identified by local testing and that has been prospectively confirmed by a central diagnostic laboratory selected by the clinical trial Sponsor to determine molecular eligibility prior to enrollment
- capability to swallow capsules intact (without chewing, crushing, or opening)
- must not have gastrointestinal disease (e.g., Crohn’s disease, ulcerative colitis, or short gut syndrome) or other malabsorption syndromes that would impact drug absorption
Contact: Dr. Shanna Stopatschinskaja at (858) 276-0000 (telephone) or clinical@tptherapeutics.com (email)
Trials Outside of U.S.
Location: Beijing Cancer Hospital (Beijing, China) and ZhongShan Hospital (Shanghai, China)
Brief Description: This is a Phase I/II study evaluating the safety, tolerability, efficacy, pharmacokinetics, and pharmacodynamics of an investigational drug (3HP-2827) in the treatment of unresectable or metastatic solid tumors with FGFR2 alterations. Approximately 130 participants.
Baseline Eligibility Criteria include, but are not limited to:
- Histologically or cytologically confirmed surgically unresectable, locally advanced, metastatic solid tumor
- Evaluable or measurable disease per RECIST v1.1 *
- No failure to swallow, chronic diarrhea, or presence of other factors affecting drug absorption
Solid Tumors Generally (Appendix cancer, including mucinous, is considered a solid tumor.)
Trials in U.S.
Study of RP1 Monotherapy and RP1 in Combination with Nivolumab (NCT03767348)
Location: Participating sites throughout U.S. and the UK. For specific sites, go to link above for this clinical trial and scroll down to “Contacts and Locations” list.
Brief description: This is a Phase 1/2 clinical study of an investigational drug (RP1) alone and in combination with nivolumab (brand name OPDIVO) in participants with advanced and/or refractory tumors determine the maximum tolerated dose and recommended Phase 2 dose, as well as to evaluate preliminary efficacy. The study will include a dose escalation phase for single agent RP1, an expansion phase with a combination of RP1 and nivolumab and a Phase 2 portion in specified tumor types for the combination therapy. Approximately 168 participants will be enrolled.
Baseline Eligibility Criteria for the cohort for which AC/PMP patients may be eligible, include, but are not limited to:
- diagnosis of a tumor that is microsatellite stability high (MSI-H) or (dMMR) for whom anti PD-1 therapy is indicated, or have refused, become intolerant to or have no further therapy options available
Contact Person: Gail Iodice at 857-701-2235 (tel.) or RPL-001-16@replimune.com (e-mail). Additional contacts also listed for each participating site. To obtain that contact information, click on the clinical trials link above for this trial and scroll down to the “Contacts and Locations” information.
Location: Multiple sites in the U.S. View them here.
Brief description: This clinical trial is a Phase 1-2, open-label, sequential-group, dose-escalation and cohort-expansion study evaluating the safety, pharmacokinetics (PK), pharmacodynamics, and antitumor activity of Zotatifin (eFT226) in subjects with selected advanced solid tumor malignancies.
Baseline Eligibility Criteria include, but are not limited to:
- Parts 1a and 1b (Dose Escalation + Fulvestrant):
- Patient has histological or cytological confirmation of breast cancer.
- Patient has metastatic disease or locoregionally recurrent disease which is refractory or intolerant to existing therapy(ies) known to provide clinical benefit.
- Patient has had prior chemotherapy, endocrine therapy, or other therapy as follows:
- Minimum of one prior line of therapy for advanced/metastatic disease.
- Maximum of five prior lines of therapy for advanced/metastatic disease.
- Recurrence or progression on at least one line of endocrine therapy in the advanced/metastatic disease setting.
- Prior treatment has included a CDK4/6 inhibitor.
- Tumor is ER+ (defined as ER IHC staining > 0%).
Contact: Mark Densel, at 858-925-8215 (telephone) or clinicaltrials@effector.com (email)
Location: National Institutes of Health Clinical Center (Bethesda, Maryland)
Brief description: This is a Phase I/II study To find a safe dose of entinostat in combination with an investigational drug (NHS-IL12) and bintrafusp alfa and to see if this treatment will cause tumors to shrink. Patients who have a cancer that may be associated with HPV infection or microsatellite stable small bowel or colorectal cancer are eligible. Approximately 107 participants will be enrolled.
Baseline Eligibility Criteria include, but are not limited to:
“patients with primary appendix cancer are considered to be colorectal cancers and are eligible to participate, since the appendix is technically a part of the colon” - NCIinfo@nih.gov
- Phase I: Subjects with cytologically or histologically confirmed locally advanced or metastatic HPV associated malignancies or MSS small bowel or colorectal cancer (Cohort 1).
- Phase II: Subjects with cytologically or histologically confirmed locally advanced or metastatic checkpoint refractory HPV associated malignancies (Cohort 2), or MSS small bowel or colorectal cancer (Cohort 3).
- Subjects with MSS colorectal or small bowel cancer must have received two prior lines of systemic chemotherapy.
- Subjects with HPV associated malignancies must have received one prior line of systemic chemotherapy as well as checkpoint therapy if checkpoint therapy is FDA approved for that specific tumor type.
- Prior checkpoint therapy is not needed where checkpoint therapy has not been FDA approved for that specific tumor type.
- Exceptions to the above include participant who are not eligible to receive the above therapies or who decline these standard treatment options after appropriate counseling has been provided.
- Participants with checkpoint refractory HPV associated malignancies (Cohort 2) must have progressed on prior anti PD-1(L1) therapy.
- Participants in Cohort 1 and 3 can be checkpoint naive or check point refractory.
- Subjects must have measurable disease, per RECIST 1.1 ***
- Participants serologically positive for HIV, Hep B, Hep C are eligible as long as the viral loads are undetectable by quantitative PCR
- CNS Eligibility includes:
- Repeat CNS imaging at least a month after definitive treatment showing CNS disease that has not progressed.
- Not progressed at least a month after definitive treatment and continued on <=10 mg of prednisone (or equivalent) for treatment of brain or central nervous system metastasis are eligible to enroll in this study.
- Participants with evidence of intratumoral or peritumoral hemorrhage on baseline imaging if the hemorrhage is grade <= 1 and has been shown to be stable on two consecutive imaging scans.
Contact: Study Contact: National Cancer Institute Referral Office at (888) 624-1937 (telephone) or ncimo_referrals@nih.gov (email); Maryland Contact: National Cancer Institute Medical Oncology Referral Office at 888-624-1937 (telephone)
PHASE 2 CLINICAL TRIALS
Appendix Cancer-Specific
Trials in U.S.
Location: Sacramento, California (University of California, Davis)
Brief description: This is a Phase II study that evaluates the clinical benefit of continuing systemic therapy with the addition of locally ablative therapies for oligo-progressive solid tumors. The primary endpoint is disease control at 3 months, defined as continuation in systemic cancer therapy without any changes or permanent discontinuation for 3 months following first day of ablative local therapy. Participants will be assigned stereotactic ablative radiotherapy (SABR) or interventional radiology (IR) ablation therapy. Approximately 300 participants will be enrolled.
Baseline Eligibility Criteria include, but are not limited to:
- Histologically and/or biochemically appendiceal cancer
- Currently on systemic therapy and a candidate to continue their current line of systemic therapy
- ≥ 1 line of systemic therapy for metastatic disease with ≥ 3 months of clinical benefit on most recent line of systemic therapy prior to the development of new metastatic lesions.
- ≤ 5 progressing or new metastatic lesions.
Contact: Study and University Contact: Selina Laqui, MD, PhD, at 916-734-0565 (telephone) or sblaqui@ucdavis.edu (email)
Flat Dose vs. Weight-based IP Chemotherapy for CRS/HIPEC (NCT04779554)
Location: Lexington, Kentucky (University of Kentucky)
Brief description: This is a Phase II Trial comparing the effectiveness of flat dose versus weight-based dose Mitomycin C of intra-peritoneal chemotherapy for patients undergoing cytoreductive surgery and heated intra-peritoneal chemotherapy (CRS/HIPEC) for advanced gastrointestinal malignancy. Approximately 100 participants will be enrolled.
Baseline Eligibility Criteria include, but are not limited to:
- Diagnosed with low-grade appendiceal mucinous neoplasm or appendiceal cancer with peritoneal carcinomatosis
- Candidate for grossly complete cytoreductive surgery
- Not currently receiving any other investigational therapeutic agents
Contact: Study and University Contact: Prakash Pandalai, MD, at 859-323-8920 (telephone) or Prakash.Pandalai@uky.edu (email)
Location: The University of Kansas Medical Center (Westwood, Kansas)
Brief description: This is a Phase II trial comparing morbidity of cytoreductive surgery and hyperthermic intraperitoneal chemotherapy (CRS-HIPEC) using mitomycin-C versus melphalan for colorectal peritoneal carcinomatosis. Approximately 100 participants will be enrolled.
Baseline Eligibility Criteria include, but are not limited to:
- Peritoneal Surface Disease (PSD) due to High-Grade Appendiceal Cancer
- No clear evidence of systemic metastases
- No prior CRS-HIPEC treatment
- Patient has a planned CC0 (Complete Macroscopic Cytoreduction (visual))
- Recorded ASA (American Society of Anesthesiologist Classification) classification
- Able to undergo complex major abdominal surgery and receive systemic chemotherapy
- No current or anticipated use of other investigational agents while in this study.
- No history/currently has non-peritoneal surface metastatic disease in addition to peritoneal surface malignancy.
Contact: Study Contact: Mazin Al-kasspooles, MD at 913-588-6568 (telephone) or mal-kasspooles@kumc.edu (email); Study Contact Backup: Ashley Shores at 913-588-1897 (telephone) or ashores@kumc.edu (email); Med Center Contact: Steve Williamson, MD at 913-588-3808 (telephone) or SWILLIAM@kumc.edu (email)
Trials Outside of U.S.
Location: Hôpital Maisonneuve-Rosemont (Montréal, Quebec, Canada,)
Brief description: The goal of this prospective phase II unicentric Canadian clinical trial is to clarify the feasibility of modified early post-operative intraperitoneal chemotherapy (mEPIC) following cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC) in the clinical context of peritoneal carcinomatosis from colorectal and appendicular neoplasms. Approximately 25 participants will be enrolled.
Baseline Eligibility Criteria include, but are not limited to:
- Histological diagnosis of appendicular or colorectal tumors with peritoneal carcinomatosis, either synchronous (< 12 months after primary diagnosis) or metachronous (>12 months after the primary diagnosis)
- Meets criteria for recommendation for cytoreductive surgery and hyperthermic intraperitoneal chemotherapy (CRS+HIPEC) followed by mEPIC
- Pre-cytoreductive surgery:
- No other malignancies other than appendicular and colorectal neoplasms with peritoneal involvement
- No known allergic reaction or major toxicity to Fluorouracil
- No contraindications to Fluorouracil, including history of coronary spasm and/or known dihydropyrimidine dehydrogenase deficiency
- Post-cytoreductive surgery:
- Patient deemed not medically suitable to receive mEPIC protocol
Contact: Mikael Soucisse, MD, FRCSC at 514-252-3400 ext 5766 (telephone) or mikael.lefebvre.soucisse@umontreal.ca (email)
Location: Guangzhou, Guangdong, China (The Sixth Affiliated Hospital of Sun Yat-sen University)
Brief description: This is a Phase II study, exploring the safety and success surufatinib and sintilimab in combination with capecitabine in patients with previously treated metastatic adenocarcinoma of small intestine or appendix carcinoma. The maximum tolerant dose of surufatinib will also be investigated with a fixed dose of sintilimab and capecitabine. Approximately 36 participants will be enrolled.
Baseline Eligibility Criteria include, but are not limited to:
- Histological or cytological documentation of appendix carcinoma.
- Failed at least one line of prior treatment
- Measurable or non measurable disease according to RECIST criteria, version 1.1 *
- Progression during or within 3 months following the last administration of approved standard therapies
- Subjects in an adjuvant setting should have progressed during or within 6 months of completion of adjuvant therapy
- Subjects who have withdrawn from standard treatment due to unacceptable toxicity warranting discontinuation of treatment and precluding retreatment with the same agent prior to progression of disease will also be allowed into the study
- Subjects may have received prior treatment with Avastin (bevacizumab)
- No prior treatment with surufatinib
- Have not received anti-programmed death-1 (PD-1) or its ligand (PD-L1) antibody, anti-cytotoxic T lymphocyte-associated antigen 4 (cytotoxic T- lymphocyte-associated Protein 4, CTLA-4) antibody or other drug/antibody that acts on T cell costimulation or checkpoint pathways.
Contact: Study and University Contact: Yanhong Deng, Ph.D, at 86-13925106525 (telephone) or 13925106525@163.com (email)
Clinical Trials Not Yet Recruiting
Intestinal & Multivisceral Transplantation for Unresectable Mucinous Carcinoma Peritonei (TRANSCAPE) (TRANSCAPE) (NCT06084780) (NOT YET RECRUITING)
Location: Cleveland Clinic Digestive Disease & Surgery Institute (DDSI), Case Comprehensive Cancer Center (Cleveland, OH)
Brief description: This is a Phase II study to assess the efficacy and safety of intestinal or multivisceral transplantation for participants with PMP not amenable to other curative-intent treatments. Participants will undergo intestinal/multivisceral transplantation. Participants will be followed for 12 months to assess efficacy and safety. Approximately 20 participants will be enrolled.
Baseline Eligibility Criteria include, but are not limited to:
- Subjects must have histologically confirmed pseudomyxoma peritonei (PMP)
- Both low-grade mucinous carcinoma peritonei (LMCP) or high-grade mucinous carcinoma (HMCP), with or without signet ring cells as well as primary or recurrent disease, will be eligible.
- PMP disease does not have any extra-abdominal metastases, with the exception of pulmonary involvement (nodal, parenchymal, and pleural).
- PMP disease is extensive and not amenable to operative management, with or without liver, pancreas, stomach, or abdominal wall involvement.
- Non-resectable PMP disease with the presence of at least one of the following conditions:
- Extensive small bowel serosa involvement, where it is not possible to preserve at least 1.5-2 m of small bowel
- Extensive infiltration of the pancreatic surface
- Mesenteric involvement causing retraction
- Need for complete gastric resection
- Urete1ic obstruction
- Liver disease with no chance to achieve R0 resection with liver remnant volume > 30%
- Recurrent disease not amenable to further resection
- No other available curative treatment options
- Subjects can have previous abdominal operations
- Exclusion Criteria:
- No receival of any other investigational agents.
- Subjects who are HIV-positive may be included in the study
Contact: Study Contact: Anil Vaidya, MD at 216-445-3041 (telephone) or VAIDYAA2@ccf.org (email)
Specific Tumor Mutations/Characteristics
KRAS
Trials in U.S.
Location: Multiple U.S. sites. To view specific locations, click here.
Brief Description: This Phase II ComboMATCH treatment trial tests how well sotorasib (AMG 510) works with and without panitumumab in treating patients with KRAS G12C mutant solid tumors that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced). Cohort 1 involves just sotorasib and Cohort 2 involves the two investigational drugs in combination. Approximately 105 participants are enrolled.
Baseline Eligibility Criteria include, but are not limited to:
- A KRAS G12C alteration as determined by the ComboMATCH screening assessment
- Cytologically/histologically confirmed advanced/metastatic solid tumor
- Patient must have progressed on at least one line of standard of care therapy in the advanced/metastatic setting
- Patients who have progressed on a prior human epidermal growth factor receptor (EGFR) inhibitor will meet this criterion
- At least one measurable lesion as defined by RECIST *
- Ability to retain oral medication and not have any clinically significant gastrointestinal abnormalities that might alter absorption
- [COHORT I]: Patient must not have been previously treated with a KRAS G12C inhibitor (might be eligible to move to COHORT II afterwards)
- [COHORT II]: Patient must have progressed after treatment at the recommended phase II dose (RP2D) of any KRAS G12C inhibitor AND HAVE NOT been previously treated with a KRAS G12C inhibitor in combination with an EGFR inhibitor
Contact: To view specific contact information for each site, click here.
Location: Multiple U.S. sites. To view specific locations, click here.
Brief Description: This is a Phase II study testing whether ZEN003694 (ZEN-3694; a BET bromodomain inhibitor) in combination with talazoparib works to shrink tumors in patients with solid tumors that are unlikely to be cured or controlled with treatment and that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced). Approximately 88 participants will be enrolled.
Baseline Eligibility Criteria include, but are not limited to:
- Histologically confirmed malignancy that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective
- Must have a tumor lesion that can be biopsied with 'low' or 'minimal' risk and at least one measurable disease site, as defined by (RECIST) version (v) 1.1 *
- Tumor lesions that are situated in a previously irradiated area may or may not be considered measurable
- Patients in cohorts 1, 2, and 4 should have at least one relevant mutation. Patients enrolled in cohorts 1-3 do not require that PARPi be the immediate prior therapy to be eligible for the trial. No variants of uncertain significance (VUS) will be allowed
- [Cohort 4]: Must have KRAS mutated advanced solid tumors. Prior treatments with KRAS inhibitors are permitted. Patients with KRAS G12C mutations must have already had KRAS G12C targeted therapy previously
- Patients must have received at least one line of systemic therapy in the advanced/metastatic setting. Subjects with diseases without known effective options, and subjects who have declined standard of care therapy prior to study introduction, are also eligible
- Not receiving any other investigational agents
- Not receiving any substances that are strong inhibitors or inducers of CYP3A4 or P-gp, strong inhibitors of BCRP, sensitive substrates of CYP1A2, proton-pump-inhibitors (H2 antagonists are allowed), and herbal medications/preparations (vitamins are allowed)
- No inability or unwilling to swallow pills
- No receiving any medications or substances that are factor Xa inhibitors and factor IIa inhibitors. Low molecular weight heparin is allowed
- No radiation to > 25% of the bone marrow
- Have not previously received ZENN003694 or an investigational BET inhibitor
- No impairment of gastrointestinal function that may significantly alter absorption
Contact: To view specific contact information for each site, click here.
Trials Outside of U.S.
Location: Department of Tumor Growth Biology, N.N. Petrov Institute of Oncology (Saint Petersburg, Russian Federation)
Brief Description: This is a Phase II study to evaluate the potential efficacy of leflunomide alone and a MEK inhibitor with either hydroxychloroquine or bevacizumab registered for the treatment of other diseases, which may also be able to affect various parts of the RAS pathway. Approximately 20 participants will be enrolled.
Baseline Eligibility Criteria include, but are not limited to:
- Histologically confirmed metastatic disease stage 4
- Documented RAS (KRAS, HRAS, NRAS) mutation identified within the last 5 years by a local test on tumor tissue
- More than 2 lines of standard drug antitumor therapy in the anamnesis
- Disease progression as defined by RECIST version 1.1 criteria *
- During the study, no progression according to RECIST 1.1 and IRECIST criteria or clinically significant (in the opinion of the physician) progression requiring a change in anticancer treatment *
Contact: Study Contact: Evgeny Imyanitov at +79013023707 (telephone) or evgeny@imyanitov.spb.ru (email); Study Contact Backup: Liliya Baboshkina at +79869932745 (telephone) or lilya_baboshkina@mail.ru (email)
BRAF
Trials in U.S.
Location: Multiple sites in the U.S. and other countries. To view specific locations, click here.
Brief Description: This is a Phase II study to evaluate the safety and efficacy of an investigational oral pan-RAF inhibitor DAY101 in pediatric, adolescent, and young adult patients with recurrent or progressive low-grade glioma or an advanced solid tumor harboring a known RAF alteration. Approximately 140 participants will be enrolled.
Baseline Eligibility Criteria include, but are not limited to:
-
- [Arm 3]: locally advanced or metastatic solid tumor with documented known or expected to be activating RAF fusion
- Age 6 months to 25 years
- Confirmation of histopathologic diagnosis of LGG and molecular diagnosis of activating BRAF alteration
- Must have received at least one line of systemic therapy and have evidence of radiographic progression
- Must have at least 1 measurable lesion as defined by RECIST v1.1 criteria *
- Tumor can’t have additional previously-known activating molecular alterations
- No symptoms of clinical progression in the absence of radiographic progression
- No known or suspected diagnosis of neurofibromatosis type 1 (NF-1)
Contact: Study Contact: Day One Biopharmaceuticals at 650-484-0899 (telephone) or firefly-1@dayonebio.com (email)
Baseline Eligibility Criteria include, but are not limited to:
- Histologically confirmed metastatic disease stage 4
- Documented RAS (KRAS, HRAS, NRAS) mutation identified within the last 5 years by a local test on tumor tissue
- More than 2 lines of standard drug antitumor therapy in the anamnesis
- Disease progression as defined by RECIST version 1.1 criteria *
- During the study, no progression according to RECIST 1.1 and IRECIST criteria or clinically significant (in the opinion of the physician) progression requiring a change in anticancer treatment *
Contact: Study Contact: Evgeny Imyanitov at +79013023707 (telephone) or evgeny@imyanitov.spb.ru (email); Study Contact Backup: Liliya Baboshkina at +79869932745 (telephone) or lilya_baboshkina@mail.ru (email)
Location: Multiple sites in the U.S. and other countries. To view specific sites, click here.
Brief Description: This is a Phase II study to evaluate the efficacy of Plixorafenib with Cobicistat in participants with locally advanced or metastatic solid tumors harboring BRAF fusions [Group A]. Approximately 135 participants will be enrolled.
Baseline Eligibility Criteria include, but are not limited to:
- Histologic diagnosis of a solid tumor
- Documentation of BRAF gene fusion in tumor and/or blood
- Received all available standard therapy, is intolerant to available therapies, or the investigator has determined that treatment with standard therapy is not appropriate.
- No current or planned participation in a study of an investigational agent or device.
- No impairment of gastrointestinal function or disease that may significantly alter absorption
- [N.B.: Read full description to identify eligibility criteria as applies to certain specific mutations and prior treatments]
Contact: Study Contact: Jessica Rine at 610-442-4517 (telephone) or jessica.rine@fore.bio (email); Study Contact Backup: Geri Bardelli at 978-835-2310 (telephone) or geraldine.bardelli@fore.bio (email); To view specific contacts for each site, click here.
Location: Northwestern University (Chicago, Illinois)
Brief description: This is a Phase II study of autophagy modulation using hydroxychloroquine in combination with encorafenib and cetuximab or panitumumab in metastatic BRAF-mutated colorectal cancer refractory to standard therapies. [N.B. per follow-up with clinical study team, inclusion of appendiceal cancer with BRAF V600E has been confirmed.]
Baseline Eligibility Criteria include, but are not limited to:
- hiistologically confirmed stage IV appendiceal cancer positive for BRAF V600E mutation and on at least 1 prior line of systemic therapy and have not had any previous BRAF inhibitor therapy
- Measurable disease as defined by RECIST 1.1 *
- Taking any type and number of prior anticancer therapies except BRAF or MEK inhibitors.
- Able to swallow and retain oral medication and must not have any clinically significant gastrointestinal abnormalities that may alter absorption.
Contact: Study Coordinator at 3126951301 (telephone) or cancer@northwestern.edu (email); Devalingam Mahalingam, MD, PhD at 312-695-1301 (telephone) or cancer@northwestern.edu (email) or mahalingam@northwestern.edu (email)
Trials Outside of U.S.
Location: Seoul St. Mary's Hospital, The Catholic University of Korea (Seoul, South Korea)
Brief Description: This is a Phase II study of dabrafenib in combination with trametinib in subjects with advanced solid tumors with BRAF V600E mutation or clinically actionable BRAF gene alterations. Approximately 30 participants will be enrolled.
Baseline Eligibility Criteria include, but are not limited to:
- Patients with BRAF V600 mutated advanced solid tumor
- Patients with other BRAF gene alterations that are regarded to be actionable by the KOSMOS MTB
- Disease progression after ≥ 1-prior line of systemic treatment and no standard treatment option
- Measurable or evaluable disease according to RECIST version 1.1 *
- Ability to take oral medications
- No prior treatment with a BRAF, MEK, or ERK inhibitor
Contact: Study and Hospital Contact: Se Jun Park, MD, PhD at 82-2-2258-6757 (telephone) or psj6936@naver.com (email)
TP53
Trials in U.S.
Locations: Multiple U.S. locations (AL, AZ, CA, CO, DE, FL, GA, HI, ID, IL, IA, KY, LA, ME, MD, MA, MN, MO, MT, NV, NJ, NM, NY, ND, OH, OK, OR, PA, PR, RI, SC, SD, TX, VA, WA, WV, WI). To view specific sites and contact information, use this link, click on the "Contacts and Locations" heading on left-side of full-study page.
Brief Description.
This Phase II ComboMATCH patient screening trial encompasses a coordinated set of clinical trials to study cancer treatment informed by genetic testing. Patients with solid tumors, including appendiceal, that have spread to nearby tissue or lymph nodes (locally advanced) or have spread to other places in the body (advanced) and have progressed on at least one line of standard systemic therapy or have no standard treatment that has been shown to prolong overall survival may be candidates for these trials.
Genetic tests look at the unique genetic material (genes) of patients' tumor cells. Patients with some genetic changes or abnormalities (mutations) may benefit from treatment that targets that particular genetic mutation.
ComboMATCH is designed to match patients to a treatment that may work to control their tumor and may help doctors plan better treatment for patients with locally advanced or advanced solid tumors.
Baseline Eligibility Criteria include but are not limited to:
- Patient must have measurable disease
- Patient must be deemed potentially eligible for a ComboMATCH Treatment Trial as assessed by the enrolling provider
- All patients must have sequencing results available from a National Cancer Institute (NCI) credentialed Designated Laboratory (DL)
- Patients must have locally advanced or advanced histologically documented solid tumors requiring therapy and meet one of the following criteria:
- Patients must have progressed on at least one line of standard systemic therapy OR
- Patients whose disease has no standard treatment that has been shown to prolong overall survival
- Patient must meet one of the following requirements:
- Patients 18 years and older who have tumor amenable to minimal risk image-guided or direct vision biopsy and must be willing and able to undergo a tumor biopsy to obtain samples for research if the patient is to enroll in a ComboMATCH treatment trial OR
- Patients 18 years and older who do not have disease that is biopsiable at minimal risk to the patient must confirm availability of an archival tumor tissue specimen for submission for research if the patient enrolls to a ComboMATCH Treatment Trial. This tumor tissue must meet the following criteria:
- Tissue must have been collected within 12 months prior to registration to the EAY191 Registration Trial
- Patient must not have had a Response Evaluation Criteria in Solid Tumors (RECIST) response (complete response [CR] or partial response [PR]) to any intervening therapy after collection of the tissue
- Formalin-fixed paraffin-embedded tumor tissue block(s) or slides must be available OR
- Patients under 18 years old must confirm availability of an archival tumor tissue specimen for submission for research if patient enrolls to a ComboMATCH Treatment Trial. This tumor tissue must meet the following criteria:
- Formalin-fixed paraffin-embedded tumor tissue block(s) or slides must be available
- NOTE: Each ComboMATCH Treatment Trial contains specific eligibility criteria. If patient is found to not be eligible for the assigned ComboMATCH Treatment Trial, indication of ineligibility will trigger re-evaluation and potential assignment to another Treatment Trial
Contact Information. View full study information, click on “Contacts and Locations” heading on left-side of full-study page to review all locations and contact information for each location of interest.
Location: Dana Farber Cancer Institute, Boston, Massachusetts
Brief description: This is a Phase 2 study of an investigational drug, Abemaciclib (a CDK inhibitor), as a possible treatment for cancer abnormality in one of the following genes: CCND1, CCND2, CCND3, CDK4, or CDK6. Approximately 38 participants will be enrolled.
Baseline Eligibility Criteria include, but are not limited to:
- Histologically or cytologically confirmed advanced solid tumor for which standard therapy proven to provide clinical benefit does not exist or is no longer effective
- Depending on treatment arm, either: (1) a confirmed CCND1, 2, or 3 high-level amplification, CCND1 mutation, or a CCND1 splice variant expected to lead to nuclear retention of cyclin D1 protein; or (2) a confirmed CDK4 or CDK6 high-level amplification
- Ability to swallow and retain oral medication
- Must not have received prior treatment with a CDK4/6 inhibitor
Contact:
Geoffrey Shapiro, MD, PhD at 617-632-4942 (telephone) or geoffrey_shapiro@dfci.harvard.edu (e-mail); or Andrew Wolanski, Nurse Practitioner, at 617-632-6623 (telephone) or andrew_wolanski@dfci.harvard.edu
Locations: Multiple sites in U.S. Go to Locations tab at NCT link provided above to review specific sites participating.
Brief description: This is a Phase 2 clinical trial that aims to describe the safety and efficacy of commercially available, targeted anticancer drugs prescribed for the treatment of patients with advanced cancer that have a potentially actionable genomic variant. This study will analyze FDA-approved targeted therapies that are contributed by collaborating pharmaceutical companies, catalogue the choice of molecular profiling test by clinical oncologists, and develop hypotheses for additional clinical trials. This study will include approximately 3,123 participants.
Baseline Eligibility Criteria include, but are not limited to:
- Histologically-proven locally advanced or metastatic solid tumor that is no longer benefiting from standard treatment or for whom, in the opinion of the treating physician, no such treatment is available or indicated
- Have a tumor genomic profile for which single agent treatment with one of the FDA-approved targeted anti-cancer drugs included in this study has potential clinical benefit based on the criteria described in the protocol. [Note: There are 19 different arms (i.e., groups or cohorts of participants) in this trial, each for a different set of tumor markers/mutations and drug/combination of drugs. To identify all these arms, go to the clinical trial link provided above (NCT02693535) and scroll down to “Arms and Interventions.”]
- Results must be available from a genomic test or immunohistochemistry (IHC) test for protein expression performed in a CLIA-certified and College of American Pathologists-accredited or New York State accredited (for labs offering services to residents of NY) laboratory that has registered the test with the NIH Genetic Test Registry or has established an integration with the TAPUR study platform. The genomic or IHC test used to qualify a patient for participation in this trial may have been performed on any specimen of the patient’s tumor obtained at any point during the patient’s care at the discretion of the patient’s treating physician. Genomic assays performed on cell-free DNA in plasma (“liquid biopsies”) will also be acceptable if the genomic analysis is performed in a laboratory that meets the criteria described above.
- Must not have a GI condition that might limit absorption of oral agents
Contact: Pam Mangat at pam.mangat@asco.org
Location: Rutgers Cancer Institute of New Jersey, New Brunswick, New Jersey
Brief description: This is Phase 2 study of how well pembrolizumab (brand name KEYTRUDA) works in treating participants with cancer that has spread to other place in the body, has come back or has spread to nearby tissues or lymph nodes. Approximately 40 participants will be enrolled.
Baseline Eligibility Criteria, include, but are not limited to:
- Diagnosis of a tumor with evidence of genomic instability on Clinical Laboratory Improvement Amendments (CLIA)-certified genomic testing, inclusive of mutations in POLE, POLD1 for arm 1 and in BRCA1 and BRCA2 for arm 2.
- Advanced cancer (metastatic, recurrent or locally advanced)
- Willing to provide archived tumor tissue; tissue from the most obtained core or excisional biopsy preferred; 20 unstained slides are referred but a minimum of 15 slides is acceptable; if adequate tissue is not present the patient may consent to a newly obtained biopsy
- Tumors harboring non-hotspot POLE or POLD1 mutations that show clear evidence of microstatellite instability (MSI) will be excluded
Contact Person: Janice M. Mehnert at 732-235-8945 (tel.) or mehnerja@cinj.rutgers.edu (e-mail)
[NOTE: All participating trial sites are in France.]
Location: Multiple cities in France. To find specific site and contacts, click on the NCT trial listed above, then go to Contacts and Locations tab
Brief description: This is a Phase 2 study to be conducted in two phases (induction period and a maintenance period) in patients with all types of progressive solid tumors after at least 1 systemic treatment regimen for advanced disease (in the absence of a validated second-line therapy). The main goal of this study is to evaluate the clinical benefit of a maintenance treatment in patients with stable disease after induction treatment with a selected therapy (Molecular Targeted Therapy or MTT) or with stable disease, partial response or complete response with immunotherapy.
For MTT, the induction phase of this trial will establish whether the identification of genomic alterations in genes encoding for “actionable” targets in the tumor cells, regardless of the histological subtype, can be used to select efficient treatment targeting the pathway activated by the mutation. For immunotherapy, the induction phase of this trial with durvalumab and tremelimumab is expected to be an innovative therapy for an efficient tumor control and may allow to identify types of cancer or molecular types of cancer that are more receptive to immunity.
The second phase of the trial (maintenance period) will use a randomized design to evaluate the clinical benefit of a maintenance treatment with the targeted therapy or immunotherapy selected based on tumor molecular profile in patients treated by MTT with stable disease and in patients treated with immunotherapy with stable disease, partial response or complete response.
Approximately 500 patients will be enrolled.
Baseline Eligibility Criteria include, but are not limited to:
- Metastatic or locally advanced and unresectable solid tumor of any type not amenable to curative treatment.
- At least one prior systemic treatment regimen for locally advanced or metastatic disease. Patients who are candidates for a validated second line treatment regimen are not eligible for the study.
- A multidisciplinary molecular board must have recommended one of the investigational MTT available for the study after review of a tumor molecular profiling previously established from a biopsied lesion and/or primitive tumor.
Other Mutations/Characteristics.
Trials in U.S.
Location: University of California (San Francisco, California)
Brief description: This is a Phase II study, examining how well Ataxia telangiectasia and Rad3-related (ATR) kinase inhibitor AZD6738 works alone or in combination with olaparib or durvalumab in treating participants with solid tumors that have spread to nearby tissue or lymph nodes or other parts of the body. Approximately 89 participants will be enrolled.
Baseline Eligibility Criteria include, but are not limited to:
- ARID1A Subgroup (N = 39):
- Histologically confirmed locally advanced or metastatic solid tumor malignancy with progression on at least one prior systemic therapy, including one of the following tumor types:
- Other solid tumors (Cohort D)
- Formalin-fixed paraffin embedded tumor tissue evaluable for BAF250a expression by ARID1A immunohistochemistry. Primary or metastatic tumor tissue is permissible. Patients without evaluable archival tissue may undergo optional tumor biopsy during Screening if other eligibility criteria have been met
- Measurable disease by RECIST 1.1 *
- Histologically confirmed locally advanced or metastatic solid tumor malignancy with progression on at least one prior systemic therapy, including one of the following tumor types:
- ATM Loss Subgroup (N = 20):
- Histologically confirmed locally advanced or metastatic solid tumor malignancy with progression on at least one prior systemic therapy, including one of the following tumor types:
- All other solid tumor malignancies (N = 10). Patients are required to have measurable soft tissue disease by RECIST 1.1 criteria *
- Archival tumor tissue evaluable for ATM expression by immunohistochemistry
- Evidence of ATM loss by either pathogenic ATM mutation in Chemiluminescent immunoassay (CLIA)-approved assay and/or loss of ATM expression by IHC (Ventana Ab). An interim analysis will be performed after 10 patients are enrolled. If less than 50% of tumors have absence of ATM expression by IHC, subsequent enrollment of the remaining 10 patients will be required to have evidence of both ATM mutation and loss of ATM expression (< 5% of tumor cells expressing ATM) using CLIA-certified IHC test (Ventana).
- Histologically confirmed locally advanced or metastatic solid tumor malignancy with progression on at least one prior systemic therapy, including one of the following tumor types:
- Evidence of clinical or radiographic progression prior to study entry
- No prior treatment with ATR inhibitor
- No clinically significant gastrointestinal abnormalities that may increase the risk of decreased absorption of medications
Contact: Study Contact: Early Phase Clinical Trials Recruitment at 877-827-3222 (telephone) or EarlyPhaseClinicalTrials@ucsf.edu (email) or cancertrials@ucsf.edu (email); Principal Investigator: Rahul Aggarwal, MD
Phase II Study of Tazemetostat in Solid Tumors Harboring an ARID1A Mutation (NCT05023655)
Location: Prisma Health Cancer Institute (Greenville, South Carolina)
Brief Description: This is a Phase II study of tazemetostat as monotherapy in solid tumors harboring an ARID1A mutation. Approximately 40 participants will be enrolled.
Baseline Eligibility Criteria include, but are not limited to:
- Histologically and/or cytologically confirmed advanced or metastatic solid tumor harboring ARID1A mutation
- Progression of disease following approved therapies or for which no standard therapy exists
- Have measurable disease as defined by RECIST 1.1 *
- No prior exposure to tazemetostat or other inhibitor(s) of EZH2.
- Not taking medications that are known potent CYP3A4 inducers/inhibitors
- Able to take oral medication
- Doesn’t have malabsorption syndrome or any other uncontrolled gastrointestinal condition that might impair absorption
Contact: Study Contact: Julie C Martin, DNP, at 864-455-3667 (telephone) or julie.martin@prismahealth.org (email); Study Contact Backup: Jan Kueber, MBA, at 864-455-3774 (telephone) or jan.kueber@prismahealth.org (email); Institute Contact: Lisa M Johnson, RN, at 864-455-3735 (telephone) or lisa.johnson@prismahealth.org (email); Institute Contact: Fiona Davidson, RN, at 864-455-3737 (telephone) or fiona.davidson@prismahealth.org (email)
Location: MD Anderson Cancer Center (Houston, Texas)
Brief Description: This is Phase II study to assess the effect of nivolumab in treating patients with solid tumors that have spread to other places in the body (metastatic) or cannot be removed by surgery (unresectable) with RID1A mutation and CXCL13 expression. Approximately 30 participants will be enrolled.
Baseline Eligibility Criteria include, but are not limited to:
- Patient will have a tumor harboring genomic mutation of ARID1A
- Histological or cytological evidence of metastatic or surgically unresectable disease harboring ARID1A mutation
- Measurable disease per RECIST 1.1 criteria *
- No prior treatment with an anti-PD-1, anti-PD-L1, anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways
Contact: Principal Investigator: Funda Meric-Bernstam at 713-563-1930 (telephone) or fmeric@mdanderson.org (email)
Location: Memorial Sloan Kettering Cancer Center (Sites in both NJ and NY)
Brief Description: This is a Phase II study to test whether reduced-dose radiotherapy is an effective treatment for metastatic tumors with an ATM mutation. The researchers want to find the lowest dose of radiation that would still be effective to treat these tumors. Approximately 29 participants will be enrolled.
Baseline Eligibility Criteria include, but are not limited to:
- Histologically confirmed malignancy with at least one metastatic lesion referred for palliative radiotherapy
- Pathogenic mutation in ATM (somatic and germline allowed)
- No previous radiotherapy to the intended treatment site that precludes developing a treatment plan that respects normal tissue tolerances.
Contact: Study Contact: Amy Xu, MD, PhD, at 646-888-6863 (telephone) or xua@mskcc.org (email); Study Contact Backup: Daniel Gomez, MD, at 212-639-2087 (telephone)
Niraparib and Dostarlimab in HRD Solid Tumors (DIDO) (NCT04983745)
Location: West Cancer Center (Germantown, Tennessee)
Brief description: This is an open-label, single-arm, Phase 2 study which will evaluate the efficacy and safety of niraparib and dostarlimab (TSR-042) combination in patients with metastatic, recurrent, or unresectable solid tumor with a pathogenic, or presumed pathogenic, somatic homologous recombination deficiency (HRD) gene mutation. Approximately 30 participants will be enrolled.
Baseline Eligibility Criteria include, but are not limited to:
- Metastatic, recurrent, or unresectable solid tumor with a pathogenic, or presumed pathogenic, somatic mutation of one of the following homologous recombination deficiency (HRD) gene mutations: BRCA1, BRCA2, ATM, etc.
- No participant must not be simultaneously enrolled in any interventional clinical trial
Contact: Study Contact: Robin Patterson, RN at 901-683-0055 ext 63019 (telephone) or rpatterson@westclinic.com (email); Study Contact Backup: Amanda Fletcher, RN at 901-683-0055 ext 61236 (telephone) or afletcher@westclinic.com (email); Location Contact: Ari VanderWalde, MD, MPH at 901-683-0055 ext 63015 (telephone) or avanderw@westclinic.com (email); Location Contact: Nibedita Chakraborty at 901-683-0055 ext 63023 (telephone) or nchakraborty@westclinic.com (email)
Location: Multiple sites in the U.S. and other countries. To view specific locations, click here.
Brief Description: This is a Phase II study designed to evaluate the safety and efficacy of targeted therapies or immunotherapy as single agents or in rational, specified combinations in participants with unresectable, locally advanced or metastatic solid tumors determined to harbor specific oncogenic genomic alterations or who are tumor mutational burden (TMB)-high as Participants will be treated with a drug or drug regimen tailored to them and will be assigned the appropriate cohort based on their genetic alteration(s). Approximately 920 participants will be enrolled.
Baseline Eligibility Criteria include, but are not limited to:
-
- Histologically or cytologically confirmed diagnosis of advanced and unresectable or metastatic solid malignancy
- Measurable disease as defined by RECIST v1.1, RANO, or INRC *
- Eligible for:
- [Cohort D]: TMB-high tumors
- [Cohort H]: PIK3CA multiple mutant-positive tumors
- [Cohort I]: BRAF class II mutant or fusion-positive tumors
- [Cohort J]: BRAF class III mutant-positive tumors
- [Cohort L]: KRAS G12C-positive tumors (excluding CRC)
- [Cohort M]: ATM Loss of Function tumors
- No current participation or enrollment in another therapeutic clinical trial
Contact: Reference Study ID Number: BO41932 https://forpatients.roche.com/ at 888-662-6728 (U.S. and Canada) (telephone) or Global-Roche-Genentech-Trials@gene.com (email)
Location: Multiple U.S. sites (CT, FL, NJ, NY, PA). To view specific locations, click here.
Brief Description: This is a Phase II study is to find out whether the study drug, TSR-042, followed by standard chemoradiotherapy (the chemotherapy drug capecitabine + radiation therapy) and standard surgery is an effective treatment for locally advanced mismatch repair deficient solid tumors. Approximately 200 participants will be enrolled.
Baseline Eligibility Criteria include, but are not limited to:
- Histologically confirmed locally advanced mismatch repair deficient solid tumor
- Solid tumors that in standard practice would be treated with neoadjuvant therapy
- No evidence of distant metastases: radiologically measurable or clinically evaluable disease
- No prior radiation therapy, chemotherapy, or surgery for tumor
- Tumor CAN’T cause symptomatic bowel obstruction
- No other invasive malignancy ≤ 5 years prior to registration. (Click here for exceptions)
- Not received prior therapy with an antibody or drug specifically targeting T- cell co-stimulation or checkpoint pathways.
- No other anticancer or experimental therapy while in the study
Contact: Study Contact: Andrea Cercek, MD, at 646-888-4189 (telephone) or cerceka@mskcc.org (email); Study Contact Backup: Neil Segal, MD, PhD, at 646-888-4187 (telephone); To view specific contact information for each site, click here.
Trials Outside of U.S.
Pemigatinib for FGF/FGFR Alterations Advanced Pan Solid Tumors (NCT06022289)
Location: Tianjin Medical University Second Hospital (Tianjin, China)
Brief Description: This is a Phase II study to demonstrate safety and efficacy of pemigatinib in the treatment of advanced pan solid tumor patients with FGF/FGFR alterations. Approximately 20 participants are enrolled.
Baseline Eligibility Criteria include, but are not limited to:
- Late stage, recurrent, or metastatic solid tumors confirmed by histology or cytology as unresectable by surgery
- According to RECIST v1.1, there is at least one measurable lesion *
- Histological confirmation of FGFR1-3 alterations, including but not limited to amplification, mutation, fusion/rearrangement, etc
- After standard treatment, the disease progresses, becomes intolerable, or standard treatment is ineffective, or there is no standard treatment plan
- Has not previously used small molecule multi target inhibitors targeting the FGFR pathway
- Able to swallow drug and not suffering from significant digestive system diseases that may interfere with absorption, metabolism, or excretion
Contact: Study Contact: PHaiTao Wang, Ph.D, PI, at +86-022-88326385 (telephone) or peterrock2000@126.com (email); Study Contact Backup: Jinhuan Wang, Ph.D, at +86-022-88326610 or wjhhappy2008@163.com (email)
Location: Multiple sites in China. To view specific locations, click here.
Brief Description: This is a Phase IIa study of infigratinib in subjects with locally advanced or metastatic gastric cancer or gastroesophageal junction adenocarcinoma with FGFR2 Amplification or other advanced solid tumors with other FGFR alterations. Approximately 80 participants are enrolled.
Baseline Eligibility Criteria include, but are not limited to:
- Eligible for Cohort 2
- Histologically or cytologically confirmed locally advanced or metastatic solid tumors
- Failed established standard medical anti-cancer therapies for a diagnosed tumor or have been intolerant to such therapy, or no standard therapy, or in the opinion of the Investigator have been considered ineligible for a particular form of standard therapy on medical grounds
- Previous documented proof of FGFR1-3 fusions/rearrangements and activating mutations
- Measurable disease by RECIST v1.1 *
- No previous or current treatment of a mitogen-activated protein kinase (MAPK-MEK) or selective FGFR inhibitor
Contact: Study Contact: Lei Mu, Master at 86 21 61329798 (telephone) or Lei.mu@lianbio.com (email); To view specific contact information for each site, click here.
Location: Multiple sites in China. Click here, for specific locations,
Brief Description: This is a Phase II trial to evaluate the efficacy and safety of an investigational drug (ICP-192) in treated patients with advanced solid tumors with FGF/FGFR Gene Alterations. Approximately 200 participants will be enrolled.
Baseline Eligibility Criteria include, but are not limited to:
- Part 2 (other solid tumor cohorts): Patients with other solid tumor who have failed or cannot tolerate standard therapy, and with FGF/FGFR gene alteration
- At least one measurable lesion as the target lesion at screening assessed according to RECIST V1.1 criteria *
- No prior treatment with selective FGFR inhibitors or FGFR antibodies.
Contact: Study Contact: Ye Guo at 13501678472 (telephone) or pattrickguo@gmail.com (email); To view specific contacts information for each site, click here.
Location: Multiple sites in Finland. To view specific locations, click here.
Brief description: This is a prospective non-randomized national clinical phase 2 trial that aims to determine the efficacy and toxicity of targeted anticancer drugs or combinations that are approved or under review by EMA, FDA or PMDA and are used for treatment of patients with advanced cancer with a potentially actionable variant as revealed by a genomic, RNA-molecular or protein expression test. Approximately 250 participants will be enrolled.
Baseline Eligibility Criteria include, but are not limited to:
- Histologically-confirmed locally advanced or metastatic cancer that is no longer benefiting from standard anti-cancer treatment or for whom no such treatment is available or indicated
- Evaluable or measurable disease (by physical or radiographic examination, according to RECIST v1.1, Lugano, IWG and ELN-AML, IMWG, RANO, GCIG, iRESIST or PCWG3
- For orally administered drugs, the patient must be able to swallow and tolerate oral medication and must have no known malabsorption syndrome
- Drug Alectinib: ALK
- Drug Cobimetinib: MEK1, MEK2
- Drug Trastuzumab+Pertuzumab: HER2
- Drug Entrectinib: NTRK/ ROS1, ALK
- Drug Atezolizumab: PD-L1
- Drug Vemurafenib: BRAF V600
- Drug Regorafenib: KIT/BRAF, RET
- Drug Dabrafenib: RAF
- Drug Dabrafenib+Trametinib: RAF, MEK1, MEK2
- Drug Pemigatinib: FGFR2
Contact: Study Contact: Tanja Juslin at +358405597415 (telephone) or tanja.juslin@hus.fi (email); To view specific contact information for each site, click here.
Location: Multiple sites in France. To view specific locations, click here.
Brief Description: This is a MOST Plus Phase II study conducted in patients with all types of progressive solid tumors after at least 1 prior systemic treatment regimen for advanced disease (in the absence of a validated second line therapy).The main goal is to evaluate the clinical benefit of a maintenance treatment in patients with stable disease (SD) after induction treatment with a selected therapy (Molecular Targeted Therapy (MTT) or with stable disease (SD), partial response (PR) or complete response (CR) with Immunotherapy (IT)). Approximately 900 participants will be enrolled.
Baseline Eligibility Criteria include, but are not limited to:
- Combination Product: Durvalumab + Tremelimumab
- Any molecular types of tumor (which are known to be immunogenic or with high mutation load), except patients who fulfill conditions to receive any other MTT of the MOST Plus study.
- Histologically or cytologically confirmed diagnosis of metastatic or locally advanced and unresectable solid tumor of any type
- Documented disease progression
- At least one prior systemic treatment regimen for locally advanced or metastatic disease
- No patients who are candidates for a validated second line treatment regimen
- Patient with measurable disease, defined as at least one lesion according to RECIST 1.1 *
- A multidisciplinary molecular board must have recommended one of the investigational MTT available in the study after review of a tumor or blood molecular profiling previously established from a biopsied lesion and/or primitive tumor, and/or from a liquid biopsy
- The MTT recommended by the multidisciplinary molecular board after the review of tumor or blood molecular profile is not approved and reimbursed in France for the disease affecting the patient in the same label.
- Affiliated to the French social security system.
- The recommended study treatment must have been approved by the medical staff of the Steering committee.
- Availability of a pre-treatment sample of primary tumor (only formalin-fixed paraffin-embedded (FFPE) block with sufficient material) and presence of at least one biopsiable tumor lesion for on-treatment biopsy
- Maximum of 2 prior lines of treatment at time of C1D1 for their metastatic or locally advanced.
- No previous treatment in advanced phase with an investigational therapy inhibiting the same target proteins as this recommended for the study.
- Palliative radiotherapy is authorized only if the irradiated field does not include target lesions.
- No condition that impairs their ability to swallow and retain tablets and may affect absorption
- No current treatment with drugs that could interfere with study drugs metabolism
- For IT: No patients who fulfill conditions to receive one of the investigational therapy of the study
Contact: Study Contact: Jean-Yves BLAY, MD at +33478785126 (telephone) or jean-yves.blay@lyon.unicancer.fr (email); Study Contact Backup: Olivier TREDAN, MD at +33478782828 (telephone) or olivier.tredan@lyon.unicancer.fr (email); To view specific contact information for each site, click here.
Location: Multiple sites in France. To view specific locations, click here.
Brief Description: This is a Phase II study evaluating the activity of anti-cancer treatments targeting tumor molecular alterations/characteristics in advanced/metastatic tumors. To view specific treatment drugs, click here and scroll to Intervention/Treatment. Approximately 455 participants will be enrolled.
Baseline Eligibility Criteria include, but are not limited to:
- Histologically confirmed diagnosis of metastatic disease or unresectable locally advanced malignancy that is resistant or refractory to standard therapies or for which standard therapies does not exist or is/are not considered appropriate by the investigator
- A multidisciplinary molecular board must have recommended the specific intervention based on the following documented actionable alterations:
- [Cohort Regoranib] : Activating mutation and/or amplification of BRAF (other than V600 mutations), CRAF, HRAS, FGFR1-2, and/or biallelic inactivation of SMAD4
- [Cohort Trametinib]: Activating mutation and/or amplification of KRAS (except all KRAS G12 mutations), NRAS, HRAS and/or MAP2K; and/or amplification or translocation of BRAF, and/or translocation RAF1
- [Cohort Trametinib + Dabrafenib]: BRAF V600 mutation.
- Previously treated by at least one prior line of treatment in the advanced/metastatic setting.
- Documented radiological disease progression as per RECIST v1.1 and presence of at least one measurable lesion according to RECIST 1.1 criteria *
- No patients amenable to therapy with curative intent
- No patients participating to another clinical trial with a medicinal product
- No patients previously treated with similar intervention meaning any agent targeting the same signaling pathways components
- No patients unable to swallow oral medication
Contact: Study Contact: Jean-Yves BLAY, MD at +33478785126 (telephone) or jean-yves.blay@lyon.unicancer.fr (email); Study Contact Backup: Olivier TREDAN, MD at +33478782828 (telephone) or olivier.tredan@lyon.unicancer.fr (email); To view specific contact information for each site, click here.
Location: Multiple sites in South Korea. To view specific locations, click here.
Brief Description: This is a Phase II study investigating the efficacy and safety of bevacizumab plus erlotinib in patients with locally advanced or metastatic solid tumors which harbor genomic alterations in the Krebs cycle (e.g. fumarate hydratase, isocitrate dehydrogenase, succinate dehydrogenase) and have had disease progression on standard systemic treatment and/or have no standard treatment option. Approximately 32 participants will be enrolled.
Baseline Eligibility Criteria include, but are not limited to:
- Histologically confirmed solid cancer
- Genetic alteration in genes related to Krebs cycle (fumarate hydratase, succinate dehydrogenase, isocitrate dehydrogenase, or maleate dehydrogenase 2). Only pathogenic and likely pathogenic variant in either germline or somatic gene will be permitted.
- Patients with locally advanced, recurrent, or metastatic disease not amenable to surgery, radiotherapy, or combined modality therapy with curative intent
- Disease progressed during or after standard treatment with no further treatment option, no standard treatment, patient's refusal to receive standard treatment, or unfit for standard treatment. If standard treatment contains bevacizumab and/or erlotinib, patient can be included according to treating physician's discretion
- Measurable disease according to RECIST v1.1 criteria *
- No previous treatment with a combination of vascular endothelial growth factor inhibitors and epithelial growth factor receptor inhibitors. Previous exposure to only one inhibitor, or sequential exposure to both agents can be included at the treating physician's discretion
- No previous radiotherapy to the only measurable lesion unless it’s the only measurable lesion
- No gastrointestinal disturbances.
Contact: Study Contact: Inkeun Park, M.D, Ph.D at +82-2-3010-3266 (telephone) or ikpark@amc.seoul.kr (email); To view specific contacts for each location, click here.
Location: Multiple sites around the world. To view specific locations, click here.
Brief description: The global objective of this Basket of Basket study is to evaluate the antitumor activity of each matched therapies that will be evaluated through the study in small molecularly selected populations. Approximately 1000 participants will be enrolled.
Baseline Eligibility Criteria include, but are not limited to:
- Subjects must have measurable disease according to RECIST 1.1 *
- Eligibilty Criteria (PART A – iPROFILER)
- Subjects must have histologically or cytologically confirmed malignancy that is metastatic or unresectable, who have progressed to standard therapy, who are receiving a standard anticancer treatment, but no subsequent approved treatment would be available upon progression, who are unable to receive standard therapy, or for whom standard therapy does not exist
- Subjects must have enough tumour tissue for molecular analysis
- No subjects with inability to swallow tablets or capsules or with known history of malabsorption
- Eligibilty Criteria (PART B - iBASKET)
- Subjects must have metastatic or unresectable malignant tumour, histologically or cytological confirmed and progressing to current therapy. Tumours must be refractory to standard therapy or for which standard therapy does not exist, or subjects may be unable to receive standard therapy.
- Participants who have received definitive radiation or surgical treatment for symptomatic or unstable brain metastases and have been clinically stable and asymptomatic for at least 2 weeks before enrolment are eligible, provided they have been either off corticosteroid treatment or are stable or tapering doses below 4 mg of dexamethasone.
- Experimental: Module 1 – Atezolizumab
- Arm 1D: hypermutated tumors
- Arm 1E: tumors with other mutations in DNA-repair genes
- Arm 1F: tumors with amplified PDL1
- Experimental: Module 2 – Futibatinib
- Arm 2A: Known pathogenic FGFR1-3 mutations
- Arm 2B: Variants of unknown significance in FGFR1-3 with functional relevance or pathogenic FGFR4 mutations.
- Arm 2C: Highly amplified FGFR1-3 with high FGFR1-3 mRNA
- Arm 2D: Highly amplifiedFGFR1-3 without high FGFR1-3 mRNA
- Experimental: Module 3 - Amivantamab
- Arm 3A: kinase domain mutations/ MET fusion-genes (including intragene exon skipping MET-MET fusions)
- Arm 3B: MET copy number gain (equivalent CNG ‚â•6) (exception: colorectal cancer)
- Arm 3C: EGFR mutations
Contact: Study Contact: Marta Carboneras at +34 686 187 838 (telephone) or mcarboneras@vhio.net (email); Study Contact Backup: Susana Muñoz at +34 934 893 000 ext 2432 (telephone) or smunoz@vhio.net (email); To view specific contact information for each site, click here.
Clinical Trials Not Yet Recruiting
Genome-Based Assessment of Niraparib (ZEJULA®) Efficacy in Advanced Solid TumorS With Homologous Recombination Deficiency (NCT06237205) (NOT YET RECRUITING)
Location: No location data
Brief description: This is a Phase II study examining patients with histologically confirmed and locally advanced, unresectable, or metastatic solid tumors having known or suspected deleterious mutations in genes involved in homologous recombination repair (HRR) or homologous recombination deficiency identified by whole genome sequencing. Approximately 33 participants will be enrolled.
Baseline Eligibility Criteria include, but are not limited to:
- Has a histologically- or cytologically-confirmed advanced (metastatic and/or unresectable) solid tumor.
- Has either known or suspected deleterious mutations in at least 1 of the genes involved in HRR or centrally confirmed HRD based on whole-genome sequencing (WGS).
- Has measurable disease per RECIST v1.1 as assessed by the local site investigator *
- No previous exposure to PARP inhibitor
- No impairment of gastrointestinal function or gastrointestinal disorders
Contact: Study Contact: soohyeon lee, phd at +82-2-920-6078 ext +82-2-920-6078 (telephone) or soohyeon_lee@korea.ac.kr (email); Study Contact Backup: chanju park, bs at +82-2-920-6078 ext +82-2-920-6078 (telephone) or ckswn4869@kumc.or.kr (email)
Solid Tumors Generally (Appendix cancer, including mucinous, is considered a solid tumor.)
Trials in U.S.
Locations: Memorial Sloan Kettering Cancer Center, NY, New York.
Brief description: This is a Phase 2 study to determine whether treatment with the investigational drug 131I-Omburtamab can prevent or delay the worsening of Desmoplastic Small Round Cell Tumors/DSRCT or other cancers of the peritoneum. This trial will enroll approximately 55 participants.
Baseline Eligibility Criteria for participants with a tumor type other than DSRCT (i.e., “Group C”) include, but are not limited to:
- Have the diagnosis of tumors other than DSRCT, confirmed at Memorial Sloan Kettering
- Have a tumor that involves the peritoneum
- Omburtamab reactivity must be confirmed by immunohistochemistry except for tumors with a reported incidence of B7H3 expression of greater than 70%
- Have a history of tumor progression or recurrence or failure to achieve complete remission after standard therapy
- Less than 20% chance of long-term disease-free survival
- Must not have clinically suspected dense intraperitoneal adhesions preventing adequate intraperitoneal distribution
Contact: Dr. Shakeel Modak at 212-639-7623 (tel.) or modaks@mskcc.org, or Dr. Emily Slotkin at 212-639-8856 (tel.) or slotkine@mskcc.org (email).
Location: National Cancer Institute Developmental Therapeutics Clinic, Bethesda, Maryland..
Brief description: This is a Phase 2 study of the side effects of durvalumab (brand name IMFINZI) when given together with chemotherapy in treating patients with advanced tumors. Giving chemotherapy with durvalumab may improve how immune cells respond and attack tumor cells. The primary outcome measure of this trial is the incidence of adverse events. Other outcome measures include changes in the microenvironment, immunotherapy response of tumor-infiltrating and circulating T-cells, and the immune status of the tumor and overall tumor mutational load. Approximately 115 participants will be enrolled.
Baseline Eligibility Criteria include, but are not limited to:
- metastatic or locally advanced (not amenable to surgery) tumors that have progressed following at least one line of standard therapy and/or no standard of treatment exists that has been shown to prolong survival
- must have tumor amenable to biopsy and be willing to undergo a tumor biopsy
- if have had prior treatment with a checkpoint inhibitor, must not have been taken off drug for serious adverse events. Patients who had prior CTLA-4 inhibitor treatment and did not experience serious adverse events are eligible for all arms. Patients who had prior PD-L1/PD-1 inhibitor treatment and did not experience serious adverse events are excluded from the durvalumab monotherapy arm but are eligible for the chemotherapy combinations.
Contact Person: NCI Site Public Contact at 1-800-411-1222
Location: Greenville Health System Cancer Institute, Greenville, South Carolina
Brief description: This is an investigator-initiated Phase 2 study of durvalumab (brand name IMFINIZI) in combination with the investigational drug, tremelimumab, in individuals with select advanced rare solid tumors. Approximately 50 patients will be enrolled.
Baseline Eligibility Criteria include, but are not limited to:
- diagnosis of a rare advanced solid malignancy meeting EORTC criteria
- willingness to undergo biopsy of a tumor site or have recent (less than 2 years) archival material available
- must not have previously received durvalumab or tremelimumab or any checkpoint inhibitor
Contacts: Julie C. Martin, DNP, 864-455-3600 extension 3667 (telephone) or julie.martin@prismahealth.org (e-mail); or Jan Kueber, RN, BSN, 864-455-3600 extension 3774 (telephone) or jan.keuber@prismahealth.org (e-mail)
Location: Multiple sites in Texas. To view specific locations, click here.
Brief description: This phase II trial studies the side effects and best dose of radiation therapy and to see how well it works in treating patients with cancer that has spread to other places in the body (metastatic) or has increased in size after being treated with immunotherapy. Approximately 230 participants will be enrolled.
Baseline Eligibility Criteria include, but are not limited to:
- Pathologically confirmed diagnosis of cancer.
- Progressive disease on prior study or standard of care therapy utilizing an immunotherapy agent OR a clinical status that requires salvage radiation treatment (e.g.: palliative RT) at the discretion of treating Physician and/or PI.
- Previous progression of disease while on treatment of an immunotherapy agent or cell-based therapy.
- Patients may continue with maintenance immunotherapy as part of standard of care therapy while receiving radiation.
- Have at least one site of metastatic disease amenable to radiation. All lesions amenable to radiation may be irradiated at the discretion of treating Radiation Oncologist, depending on the location, size and number of lesions.
Contact: Study Contact: James Welsh, MD at 713-563-2300 (telephone) or jwelsh@mdanderson.org (email); To view specific contact information for each site, click here.
Location: Sidney Kimmel Comprehensive Cancer Center (Baltimore, Maryland)
Brief description: This is a Phase II study to evaluate the safety and clinical activity of nivolumab and relatlimab in patients with microsatellite instability high (MSI-H) solid tumors refractory to prior PD-(L)1 therapy. Approximately 42 participants will be enrolled.
Baseline Eligibility Criteria include, but are not limited to:
- Have metastatic or locally advanced mismatch repair deficient/MSI-H disease.
- Patients must have received prior PD-1/PD-L1 inhibitor therapy
- Patients with the presence of at least one measurable lesion.
- No prior treatment with anti-LAG3.
Contact: Study Contact: Colleen Apostal, RN or Joann Santmyer, RN or Trish Brothers, RN at 410-614-3644 (telephone) or GIClinicaltrials@jhmi.edu (gmail)
Adoptive Transfer of Tumor Infiltrating Lymphocytes for Advanced Solid Cancers (NCT03935893)
Location: UPMC Hillman Cancer Center (Pittsburgh, Pennsylvania)
Brief description: This is a Phase II study to evaluate the efficacy of a non-myeloablative lymphodepleting preparative regimen followed by infusion of autologous tumor infiltrating lymphocytes (TIL) and high-dose aldesleukin in patients with locally advanced, recurrent, or metastatic cancer. Approximately 240 participants will be enrolled.
Baseline Eligibility Criteria include, but are not limited to:
- “Measurable locally advanced, recurrent, or metastatic cancer associated with one of the following cancer types: 1.) gastric/esophagogastric, 2.) colorectal, 6.) neuroendocrine, 9.) mismatch repair deficient and/or microsatellite unstable cancers, and 10.) patients who have exhausted conventional systemic therapy options. [N.B. PI (Udai Kammula) has confirmed appendix cancer patients are also eligible.]
- Patients with locally advanced disease should be unresectable by conventional surgical approaches.
- Patients with distant metastatic spread must have previously received approved first-line systemic therapies if they are eligible to receive these treatments.
Contact: Study Contact: Josh Tobin, RN at 412-864-7754 (telephone) or tobinja@upmc.edu (email); Study Contact Backup: Allyson L Welsch, RN at 412-623-6763 (telephone) or welscha2@upmc.edu (email); Principal Investigator: Udai S Kammula, MD at kammulaus@upmc.edu
A Study of AdAPT-001 in Subjects With Sarcoma and Refractory Solid Tumors (BETA-PRIME) (NCT04673942)
Location: Multiple U.S. sites (CA, OH, TX). To view specific locations, click here.
Brief description: This is a PHASE 2: (OPEN to Enrollment) of subjects with advanced solid tumors. They will participate in Arm 2: Confirmed Histological Diagnosis of Advanced Solid Tumor indicated to receive at least one checkpoint inhibitor. The purpose of this study is to find out if an investigational oncolytic virus (AdAPT-001) is safe and tolerable. The next step is to find out if AdAPT-001 if efficacious with or without a checkpoint inhibitor. Approximately 55-80 participants will be enrolled.
Baseline Eligibility Criteria include, but are not limited to:
- Subject has a histologically or cytologically confirmed diagnosis of an advanced malignant solid tumor(s) who have received all conventional therapies considered appropriate by Investigator and have a tumor that is easily accessible and/or palpable for treatment. Ultrasound guidance may be used to aid administration
Contact: Study Contact: Jeannie Williams at 858-947-6644 (telephone) or jwilliams@epicentrx.com (email); To view specific contact information for each site, click here.
Reduced Intensity Haploidentical BMT for High Risk Solid Tumors (NCT01804634)
Location: Multiple sites in Maryland and New York. For specific contact sites, click here.
Brief Description: The purpose of this study is to see if giving reduced intensity chemotherapy, haploidentical bone marrow, post-transplant cyclophosphamide and shortened duration tacrolimus is safe and feasible for patients with very high-risk solid tumors. Approximately 60 participants will be enrolled.
Baseline Eligibility Criteria include, but are not limited to:
- Presence of a suitable related HLA-haploidentical bone marrow donor. The donor and recipient must be identical at at least one allele of each of the following genetic loci: HLA-A, HLA-B, HLA-Cw, HLA-DRB1, and HLA-DQB1. A minimum match of 5/10 is therefore required, and will be considered sufficient evidence that the donor and recipient share one HLA haplotype.
- 1-50 years old
- Patients must have a confirmed histopathologic diagnosis and be classified as high risk defined by having an expected survival of < 10%. Examples include:
- Any other solid tumor and soft tissue sarcoma with an estimated <10% chance of survival will be considered on a case by case basis at the departmental tumor board and/or sarcoma meeting
- It is expected that patients will have received upfront standard of care therapy for their respected disease
- Patients who relapse after either single or tandem autologous BMT are eligible (> 6 months must have elapsed from start of last BMT).
- Patients do not need to have measurable disease at time of enrollment. Patients with measurable disease must have stable disease by RECIST criteria on two scans at least 6 weeks apart.
- Patients must be willing to participate in all stages of treatment
- No Donor (donor anti-recipient) ABO incompatibility if an ABO compatible donor is available
- Donors must meet the selection criteria as defined by the Foundation for the Accreditation of Hematopoietic Cell Therapy
- Lack of recipient anti-donor HLA antibody
- In some instances, low level, non-cytotoxic HLA specific antibodies may be permissible if they are found to be at a level well below that detectable by flow cytometry. This will be decided on a case-by-case basis.
Contact: Study Contact: Heather Symons, MD, MHS at 410-502-4997 (telephone) or hsymons2@jhmi.edu (email); Study Contact Backup: Jasmine Brooks, BA at 667-306-8335 (telephone) or jbrook54@jhmi.edu (email); To view specific contact information for each site, click here.
Autologous TLPO Vaccine Basket (NCT06175221)
Location: Southside Medical Center (Greenville, South Carolina)
Brief Description: This is a Phase IIa study to learn about TLPO (Tumor Lysate, Particle Only) cancer vaccine in cases of solid tumor malignancies. Approximately 100 participants will be enrolled.
Baseline Eligibility Criteria include, but are not limited to:
- Stage I-IV patients
- Demonstrated tolerance of maintenance or adjuvant immunotherapy, targeted therapy, and/or hormonal therapy for three doses (if maintenance therapy is indicated)
- Completion of standard adjuvant therapy to include chemotherapy, radiation therapy, and/or other immunosuppressive therapy as clinically indicated
- Patient must have a site of disease with planned incisional or excisional procedure expected to result in sufficient tissue for vaccine creation, or must be amenable to biopsy and be a candidate for tumor biopsy with anticipated sufficient tumor tissue resulting to vaccine creation.
- Not involved in other clinical trials.
Contact: Study Contact: Pauline Nichols, PA, at 864-312-5156 (telephone) or pauline.nichol@eliosholdings.com (email); Med Center Contact: Thaer Joudeh
A Study of IBI363 in Subjects With Advanced Solid Malignancies (NCT06281678)
Location: University of Kansas Medical Center Research Institute (Fairway, KS)
Brief Description: This is a Phase II study designed to evaluate the efficacy, safety and tolerability of an investigational drug (IBI363; PD1-IL2m) in subjects with advanced, refractory solid malignancies. Approximately 160 participants will be enrolled.
Baseline Eligibility Criteria include, but are not limited to:
- General (please click on link to review. Also would need to contact the study team to determine whether this is a trial that would permit appendiceal as part of the colorectal cancer cohort).
Contact: Saqib Abbasi at 913-945-7545 (telephone) or sabbasi@kumc.edu (email)
Location: National Institutes of Health Clinical Center (Bethesda, Maryland)
Brief Description: This phase II trial tests how well atezolizumab works in combination with tiragolumab in treating patients with rare solid tumors that may have spread from where they first started to nearby tissue, lymph nodes, or distant parts of the body (advanced stage). Approximately 15 participants will be enrolled.
Baseline Eligibility Criteria include, but are not limited to:
- Histologically confirmed rare solid tumors that have progressed on standard therapy or for whom there is no standard of care therapy
- Must NOT be eligible for a higher priority study, such as a disease specific study of phase 2 or higher or a randomized study. Specifically, patients who are eligible for the PEP-CTN (pediatric trial of atezolizumab and tiragolumab in children, adolescents, and young adults with SMARCB1- or SMARCA4-deficient tumors) should be excluded
- Patients must have measurable disease as defined by RECIST v1.1, with at least one lesion that can be accurately measured in at least one dimension as >= 20 mm by or as >= 10 mm *
- Patients must have a tumor site amenable to biopsy
- Not receiving any other investigational agents
- No prior anti-TIGIT therapy. Other prior immune checkpoint inhibitor therapy permitted
- No history or risk of autoimmune disease (click here for exceptions, scroll to Exclusion Criteria)
Contact: Site Public Contact: 800-411-1222 (telephone); Principal Investigator: Naoko Takebe
Location: Multiple sites in the U.S. and other countries. To view specific locations, click here.
Brief description: The purpose of this study is to assess the safety, pharmacokinetics, and immunogenicity of tiragolumab and atezolizumab intravenous fixed-dose combination (IV FDC) in participants with histologically confirmed PD-L1-selected solid tumors whose disease is locally advanced, recurrent, or metastatic and for whom an investigational agent in combination with an anti-PD-L1 antibody is considered an acceptable treatment option. Approximately 60 participants will be enrolled.
Baseline Eligibility Criteria include, but are not limited to:
- Histologic documentation of locally advanced, recurrent, or metastatic malignancy, ineligible for definitive local therapy, for which a clinical trial of an investigational agent in combination with an anti-PD-L1 antibody is considered an acceptable treatment option. Participant must be informed of all standard of care options available for his/her cancer.
- No prior treatment with immune checkpoint inhibitor therapies (CPI-Naive)
- Measurable disease per Response Evaluation Criteria in Solid Tumors, Version 1.1 *
- PD-L1 selected tumors, as determined by the investigational VENTANA PD-L1 (SP263) immunohistochemistry (IHC) assay
Contact: Study Contact: Reference Study ID Number: GO44096 https://forpatients.roche.com/ at 888-662-6728 (U.S. Only) (telephone) or global-roche-genentech-trials@gene.com (email)
Trials Outside of U.S.
Tiragolumab and Atezolizumab in Advanced Pan-cancer Patients (MoST-TAP) (NCT06003621)
Location: Multiple sites in Australia. For specific locations, click here.
Brief Description: This phase II study will explore the effect of 2 monoclonal antibodies, tiragolumab and atezolizumab, in patients with locally advanced solid cancers which cannot be removed by surgery or have spread. Tumours assessed as amenable to tiragolumab and atezolizumab treatment will be recommended for participation in the study. Approximately 96 participants will be enrolled.
Baseline Eligibility Criteria include, but are not limited to:
- Histologically or cytologically confirmed locally advanced unresectable or metastatic solid tumour
- Exhausted all available standard therapy or not suitable for standard therapy (including targeted therapies) for the tumour
- Sufficient and accessible tumour tissue for panel sequencing, PD-L1 and TIL testing, and tertiary objectives
- Tumour biomarker criteria predictive of immune response defined by presence of one or more of the following;
- tumour mutation burden ≥ 10 mutations per megabase.
- tumour PD-L1 expression TAP score ≥ 5%
- PD-L1 amplification >6 copy number alterations
- tumour infiltrating lymphocytes (TILs) (CD3+CD8+) ≥ 5%.
- Measurable disease as defined by RECIST or RANO criteria
- Asymptomatic patients with treated or untreated CNS lesions are eligible, provided criteria is met (click here for specifics, scroll to Exclusion, number 7)
- No prior use of approved or investigational anti-TIGIT therapy
- No prior treatment with CD137 agonists or immune checkpoint blockade therapies, including anti-CTLA-4, anti-PD-1, and anti-PD-L1 therapeutic antibodies.
- No active or history of autoimmune disease or immune deficiency with some exceptions (click here for exceptions, scroll to Exclusion, number 12)
- No active or prior documented inflammatory bowel disease requiring systemic treatment within the past 2 years
- No positive EBV viral capsid antigen (VCA) IgM test
Contact: Study Contact: Simone Jacoby at +61 2 8052 4300 (telephone) or most-tap@georgeinstitute.org.au (email); Study Contact Backup: Vanessa Jones at +61 2 8052 4300 (telephone) or most-tap@georgeinstitute.org.au (email); To view specific contact information for each site, click here.
KN035 for dMMR/MSI-H Advanced Solid Tumors (NCT03667170)
Location: Peking University Cancer Hospital, Peking University (Beijing, China)
Brief Description: This is a Phase II study of patients with previously-treated locally-advanced or metastatic mismatched repair deficient (dMMR) or microsatellite instability-high (MSI-H) colorectal carcinoma (CRC) and other solid tumors that will be treated with an investigational drug (KN035). Approximately 200 participants will be enrolled.
Baseline Eligibility Criteria include, but are not limited to:
- Histologically confirmed locally advanced or metastatic colorectal carcinoma or other malignant solid tumors
- Confirmed MMR deficient or MSI-H status
- At least one measureable lesion *
Contact: Lin Shen, MD, at 86-10-88196340 (telephone) or doctorshenlin@sina.cn (email)
ENVAFOLIMAB Single-agent Treatment in Patients With Advanced Solid Tumors (NCT04891198)
Location: Beijing Cancer Hospital (Beijing, China)
Brief Description: This is a Phase II study of envafolimab single-agent treatment in patients with advanced solid tumors to compare the overall response rate of TMB-high and TMB-Low, determine the cut off value between TMB-high and TMB-Low of diagnosis device, and then observe the efficacy of ENVAFOLIMAB used confirmed TMB-H Value. Approximately 126 participants will be enrolled.
Baseline Eligibility Criteria include, but are not limited to:
- Patients with unresectable or metastatic advanced solid tumors confirmed by histology or cytology
- Subjects with advanced malignant solid tumors who had disease progression or intolerance and no satisfactory alternative treatment with at least first-line standard treatment
- If recurrence occurs during adjuvant/neoadjuvant therapy or within 6 months after completion, adjuvant/neoadjuvant therapy is considered to be the first-line treatment for advanced disease
- Have not received immune checkpoint inhibitor treatment
- Have tissue and blood samples that can detect TMB specimen
- There is at least one measurable lesion (RECIST 1.1 standard) *
- No tumor tissue samples were MSI-H
Contact: Lin Shen, MD at 86-10-88196340 (telephone) or doctorshenlin@sina.cn (gmail)
Location: Cancer Hospital Chinese Academy of Medical Science (Beijing, China)
Brief description: This is Phase II study to evaluate the preliminary efficacy of an investigational drug (GH21) combined with primary targeting or immunotherapy in patients (PD-1; EGFR Monoclonal antibody; MET/ALK/BRAF/MEK Inhibitors) with advanced solid tumors which targeted or immunotherapy has progressed. Approximately 72 participants will be enrolled.
Baseline Eligibility Criteria include, but are not limited to:
- Patients with advanced solid tumors confirmed by cytological or histological assessments
- Patients have at least one measurable lesion as defined by RECIST v1.1 (a tumor lesion in the area that has undergone radiotherapy or other loco-regional therapies, is generally not considered as measurable unless there is a disease progression in the lesion) *
- No subjects with gastrointestinal disorders that affect drug absorption, or other malabsorption conditions
Contact: Study Contact: Yiming Zhou, Bachelor at +86-512-86861608 (telephone) or zhouyiming@genhousebio.com (email); Hospital Contact: Ning Li, Doctorate at +86-10-87788495 (telephone) or lining@cicams.ac.cn (email)
Intra-tumor Injection of Drug-eluting Microspheres With Multiple Drugs (NCT04770207)
Location: The Second Affiliated Hospital of Guangzhou Medical University (Guangzhou, Guangdong, China)
Brief Description: This is a Phase II study of the safety and clinical effect of injection of drug-eluting microspheres loaded with multiple chemo drugs plus checkpoint inhibitors and IL2 for treatment of advanced solid tumors. Approximately 100 participants will be enrolled.
Baseline Eligibility Criteria include, but are not limited to:
- Solid advanced malignant tumors
Contact: Study Contact: Bingjia He, MD, at +862039195965 (telephone) or or 13560199303 (telephone) or 464677938@qq.com (email); Study Contact Backup: Zhenfeng Zhang, MD, PhD, at +862039195966 (telephone) or zhangzhf@gzhmu.edu.cn (email)
Location: The Second Affiliated Hospital of Guangzhou Medical University (Guangzhou, Guangdong, China)
Brief Description: This is a Phase II study of the clinical effect of Trametinib combined with Everolimus and Lenvatinib in the treatment of Recurrent/Refractory advanced solid tumors. Approximately 100 participants will be enrolled.
Baseline Eligibility Criteria include, but are not limited to:
- Recurrent/Refractory advanced solid tumors
- Not a “benign” tumor
Contact: Study Contact: Zhenfeng Zhang, MD, PhD at +862039195966 (telephone) or +86-020-39195966 (telephone) or zhangzhf@gzhmu.edu.cn (email); Study Contact Backup: Bingjia He, MD, at +862039195966 (telephone) or +86-14748877800 (telephone) or zhangzhf@gzhmu.edu.cn (email) or 464677938@qq.com (email)
Location: Fudan University Shanghai Cancer Center (Shanghai, China)
Brief Description: This is a Phase II study to evaluate the efficacy and safety of cryoablation combined with Tislelizumab plus Lenvatinib for patients with previously treated solid tumors. Approximately 25 participants will be enrolled.
Baseline Eligibility Criteria include, but are not limited to:
- Failed from chemotherapy or other anti-cancer therapy or standard therapy was no longer feasible
- Previous receival of anti-angiogenesis or anti-PD1/PDL1 therapy is eligible.
- At least one measurable site of disease as defined by RECIST v1.1 *
- No prior treatment with cryoablation
- No second primary cancer (some exceptions)
Contact: Peng Wang, MD, at 86-21-64175590 (telephone) or 862164175590 ext 83630 (telephone) or wangp413@163.com (email) or peng_wang@fudan.edu.cn (email)
A Study of WX390 in Patients With Advanced Solid Tumors (NCT06117540)
Location: Fudan University Shanghai Cancer Center (Shanghai, China)
Brief Description: This is a Phase II study to evaluate the efficacy and safety of an investigational drug (WX390) in patients with advanced solid tumors. Approximately 70 participants will be enrolled.
Baseline Eligibility Criteria include, but are not limited to:
- Histological or cytological confirmed advanced solid tumor, standard regimen failed
- At least one measurable lesion according to RECIST 1.1 *
Contact: Jiajia Li at 008621-64175590 (telephone) or doc_lijiajia@163.com (email); Principal Investigator: Xiaohua Wu, PhD
Local Radiotherapy in Combination With Immunotherapy in Advanced Solid Tumors Patients (NCT05097781)
Location: Ruijin Hospital, Shanghai Jiaotong University School of Medicine (Shanghai, China)
Brief Description: This is a Phase II study to observe the efficacy of combining local radiotherapy with PD-1blockade immunotherapy in patients with advanced solid tumors. Approximately 55 participants will be enrolled.
Baseline Eligibility Criteria include, but are not limited to:
- Clear pathological diagnosis of the primary site
- Multiple distant metastases
- imaging with ≥ 2 clearly assessable lesions (bone metastases alone without soft tissue mass formation, brain metastases not as target lesions)
- Progression after ≥ 1 prior line of therapy regimen with no standard treatment regimen or intolerable toxicities
- Failed to respond to at least one prior standard of care regimen
- Not have a conventional treatment option that is clinically proven to provide long-term control of the disease and the patient refuses other conventional treatment options
- Intolerance to the toxic side effects of the standard treatment regimen
- No prior immunotherapy history
- No long-term maintenance steroid therapy
- No previous immunotherapy for other tumors
Contact: Study Contact: Yujie Wang, MD at 8602164370045 ext 602400 (telephone) or wyj12054@rjh.com.cn (email); Study Contact Backup: Yunsheng Gao, MD at gys11856@rjh.com.cn (email); Principal Investigator: Jiayi Chen, MD at +86-021-64370045 ext 602400 (telephone) or cjy11756@rjh.com.cn (email)
Location: Fudan University ShangHai Cancer Center (Shanghai, China)
Brief Description: This is a Phase IIa/IIb study to evaluate the safety, tolerability, pharmacokinetics and efficacy of an investigational drug (BL-B01D1) for injection in patients with multiple solid tumors, including locally advanced or metastatic urinary system tumors. Approximately 32 participants will be enrolled.
Baseline Eligibility Criteria include, but are not limited to:
- Locally advanced or metastatic urinary system tumors and other solid tumors that have been confirmed by histopathology and/or cytology to have failed or been intolerant to standard treatment or currently have no standard treatment. Intolerance refers to grade 3-4 adverse reactions after a patient has received standard treatment, and the patient refuses to continue the original treatment.
- At least one measurable lesion that meets the RECIST v1.1 definition *
Contact: Study Contact: Hai Zhu, PHD at +8613980051002 (telephone) or zhuhai@baili-pharm.com (email); Study Contact Backup: Sa Xiao, PHD at +86-15013238943 (telephone) or xiaosa@baili-pharm.com (email); University Contact: Dingwei Ye, PHD at 021-64175590 (telephone) or dwyeli@163.com (email)
QL1604 Monotherapy for dMMR or MSI-H Advanced Solid Tumors (NCT04326829)
Location: Fudan University Cancer Hospital (Shanghai, China) and West China Hospital, Sichuan University (Chengdu, Sichuan, China)
Brief description: This is a Phase II study to evaluate efficacy and safety of an investigational drug (QL1604) for the treatment of unresectable or metastatic mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H) solid tumors that failed to respond to standard therapy. Approximately 86 participants will be enrolled.
Baseline Eligibility Criteria include, but are not limited to:
- Histologically confirmed locally advanced or metastatic dMMR or MSI-H status colorectal carcinoma or other malignant solid tumors
- At least one measurable lesion as defined per RECIST Version (v) 1.1 *
- Subjects who have disease progression or intolerable reactions after the currently available standard anti-cancer treatment previously received or refused prior cancer therapy regimen(s)
- No prior therapy with an anti-programmed cell death (PD)-1, anti-PD-ligand 1 (anti-PD-L1), anti-PD-L2 agent, cytotoxic lymphocyte associated protein-4 (CTLA-4), OX-40, CD137
Contact: Study Contact: Shunjiang Yu, CMO, at 0531-83129659 (telephone) or shunjiang.yu@qilu-pharma.com (email); Study Backup and Shanghai Contact: Weijian Guo, Professor, at 021-64175590 (telephone); Sichuan Contact: Feng Bi, Professor
Location: Cancer Hospital, Shantou University Medical College (Shantou, Guangdong, China)
Brief description: This is a phase II study to validate the clinical value of combining ILDR and programmed cell death-1 (PD-1) inhibitors in patients with metastatic malignant solid tumors who have failed immunotherapy. Approximately 60 participants will be enrolled.
Baseline Eligibility Criteria include, but are not limited to:
- According to RECIST criteria, at least one accessible and measurable lesion should be selected as the target lesion for observation *
- Patients with metastatic solid tumors (of any histology) without standard therapy options, who have previously received immunotherapy, immunotherapy combined with chemotherapy, or immunotherapy combined with anti-angiogenesis treatment and have shown disease progression.
- Assessed as unsuitable for surgical treatment.
- No patients who were assessed as hyperprogressive disease (HPD) (our previous study found that patients assessed as HPD did not benefit from ILDR and even had worse prognosis).
Contact: Chuangzhen Chen, MD at +86 13923995569 (telephone) or czchen2@stu.edu.cn (email) and stccz@139.com (email)
Thymalfasin-based PRaG Mode for Advanced Refractory Solid Tumors (NCT05790447)
Location: The Second Affiliated Hospital of Soochow University (Suzhou, China)
Brief Description: This is a Phase II trial of precise thymalfasin-regulated therapy combined with hypofractionated radiotherapy, PD-1/PD-L1 inhibitor sequential GM-CSF for treatment of advanced refractory solid tumors. Approximately 60 participants will be enrolled.
Baseline Eligibility Criteria include, but are not limited to:
- Recurrent or metastatic advanced solid malignant tumors without definitely recommended standard treatment regimen in the guidelines, and cannot tolerate or are unwilling to receive the standard treatment regimen, and have clear, measurable metastatic lesions (>1cm)
Contact: Study and Hospital Contact: Liyuan Zhang at 0512-67784829 (telephone) or +8613375183257 (telephone) or zhangliyuan126@126.com (email) or kkyuehong@163.com (email)
A Study of SHR-1802 in Patients With Advanced Solid Tumor (NCT05208177)
Location: Tianjin Medical University Cancer Institute & Hospital (Tianjin, China)
Brief Description: This is a Phase II study to assess the safety and tolerability of an investigational drug (SHR-1802) combined with camrelizumab injection and famitinib malate capsules in subjects with advanced solid tumors and to determine the dose-limiting toxicity (DLT), recommended phase II dose (RP2D) and objective response rate (ORR). Approximately 124 participants will be enrolled.
Baseline Eligibility Criteria include, but are not limited to:
- At least one measurable lesion according to RECIST v1.1 *
- Pathologically confirmed advanced solid tumor
- Have not received prior therapy with camrelizumab, and famitinib
Contact: Study Contact: Quanren Wang, Ph.D. at 86-021-23511999 (telephone) or quanren.wang@hengrui.com (email); Study Contact Backup: Liang Hu, P.M at 18036618148 (telephone) or liang.hu@hengrui.com (email); Principal Investigator: Jihui Hao
Location: Henan Cancer Hospital (Zhengzhou, Henan, China)
Brief Description: This Phase II study in Chinese adult participants with recurrent, locally advanced or metastatic esophageal carcinoma or other advanced solid tumors, which is designed to investigate the efficacy, safety, pharmacokinetics and immunogenicity of an investigational drug (HS-20093). Appendix Cancer patients may only be eligible for phase IIa. Approximately 220 participants will be enrolled.
Baseline Eligibility Criteria include, but are not limited to:
- Histologically or cytologically confirmed, relapsed, locally advanced or metastatic esophageal carcinomas and other advanced solid tumor.
- At least one extra measurable lesion according to RECIST 1.1 *
Contact: Study Contact: Jing Ding at 86-371-65588251 (telephone) or dingjing201305@163.com (email); Hospital Contact: Suxia Luo, MD at 18638553211 (telephone) or luosxrm@163.com (email)
Location: Multiple Sites in China. To view specific location sites, click here.
Brief description: This is a Phase II study with where participants previously treated locally advanced unresectable or metastatic solid tumors with mismatched repair deficient (dMMR) or microsatellite instability-high (MSI-H) will be treated with anti-PD-1 Monoclonal Antibody Tislelizumab (BGB-A317). Approximately 200 participants will be enrolled.
Baseline Eligibility Criteria include, but are not limited to:
- Histological confirmed diagnosis of malignancy
- Having locally advanced unresectable or metastatic solid tumors with MSI-H or dMMR
- Having received prior cancer therapy regimen(s) for advanced disease.
- At least 1 measurable lesion as defined per RECIST Version (v) 1.1 *
- No prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2 or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways
Contact: Study Contact: BeiGene at +1-877-828-5568 (telephone) or clinicaltrials@beigene.com (email)
Location: Multiple sites in China with various levels of recruitment. To view specific locations, click here.
Brief Description: This is a Phase II study to determine the efficacy and safety of hypofractionated radiotherapy combined with a PD-1 inhibitor and two investigational drugs (GM-CSF and IL-2) for the treatment of advanced multiple metastatic refractory solid tumors. Approximately 66 participants will be enrolled.
Baseline Eligibility Criteria include, but are not limited to:
- Recurrence or metastasis of advanced solid malignant tumors
- A clear pathological diagnosis report or medical history
- Guidelines do not clearly recommend standard treatment plans or cannot tolerate standard treatment plans
- Clear measurable metastatic lesions (>1cm)
Contact: Study Contact: Liyuan Zhang, Dr at 0086-0512-67784827 (telephone) or zhangliyuan126@126.com (email); To view specific contact information for each site, click here.
Location: Multiple sites in China. To view specific locations, click here.
Brief Description: This is a Phase II study to evaluate an investigational drug (HLX10) for the treatment of unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) solid tumors that failed to respond to standard therapy. Approximately 108 participants will be enrolled.
Baseline Eligibility Criteria include, but are not limited to:
- Unresectable or metastatic MSI-H or dMMR malignant solid tumors which are histopathologically or/and cytologically
- Disease progression or intolerable reactions after the currently available standard anti-cancer treatment previously received
- There is at least one measurable lesion assessed by IRRC according to RECIST version 1.1 *
- Measurable lesions cannot be selected from the previous radiotherapy sites. If the target lesion of the previous radiotherapy sites is the only one available lesion, the investigator is required to provide imaging data before and after significant progression of such lesion
- Subjects must provide tumor tissues and blood samples for the determination of MSI, tumor mutational burden (TMB), PD-L1 expression level
- Other anti-tumor treatments such as chemotherapy, targeted therapy or radiotherapy (excluding palliative radiotherapy) may be received during the study
- Not previously received treatment with any T cells costimulation or immune checkpoint, including but not limited to cytotoxic T lymphocyte-associated antigen-4 (CTLA-4) inhibitors, PD-1 inhibitors, PD-L1/2 inhibitors or other targeted T cells drugs.
- No participation in other clinical studies during this study
Contact: Study Contact: ShuKui Qin at 86-025-80864362 (telephone) or luolinhua0513@163.com (email); To view specific contact information for each location, click here.
Location: IRCCS Istituto ROmagnolo per lo Studio dei Tumori "Dino Amadori"-IRST S.r.l. (Meldola, Forlì Cesena)
Brief Description: This is a Phase II study to evaluate the Fibroblast Activating Protein (FAP) positivity in patients with solid tumors. The targeting of this enzyme for imaging and endo-radiotherapy can be seen as a promising strategy for detecting and treating malignant tumors. Approximately 100 participants will be enrolled.
Baseline Eligibility Criteria include, but are not limited to:
- Histologically or cytologically solid tumors at any stage
- 18-Fluorine-2-fluoro-2-deoxy-D-glucose fluorodeoxyglucose Positron emission tomography / Computerized tomography or other clinical practice morpho-functional imaging scan dubious or inconclusive
Contact: Forlì Cesena Location: Oriana Nanni at +390543739266 (telephone) or oriana.nanni@irst.emr.it (email); Bernadette Vertogen at +390544286058 (telephone) or bernadette.vertogen@irst.emr.it (email); Principal Investigator and Study Chair: Paola Caroli
Combining Epigenetic And Immune Therapy to Beat Cancer. (CAIRE) (NCT04705818)
Location: Multiple sites in France. To view specific locations, click here.
Brief description: This is a Phase II study to assess the efficacy of durvalumab when prescribed with tazemetostat. Approximately 173 participants will be enrolled.
Baseline Eligibility Criteria include, but are not limited to:
- Cohort C: patients with metastatic solid tumors with positive interferon gamma signature and/or tertiary lymphoid structure positive
- Advanced disease defined as metastatic or unresectable locally advanced disease
- Measurable disease according to RECIST *
- Participant must have advanced disease and must not be a candidate for other approved therapeutic regimen known to provide significant clinical benefit based on investigator judgment,
- No previous treatment with durvalumab or tazemetostat,
- Has not received prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or CTLA-4 antibody,
- No participants with any condition that impairs their ability to swallow and retain tablets,
Contact: Study Contact: Antoine ITALIANO, MD,PhD at (0)5.56.33.33.33 ext +33 (telephone) or a.italiano@bordeaux.unicancer.fr (email); Study Contact Backup: Simone MATHOULIN-PELISSIER, MD,PhD at s.mathoulin@bordeaux.unicancer.fr (email); To view specific contact information for each site, click here.
Location: Multiple sites in France. To view specific locations and recruitment statuses, click here.
Brief description: This is a Phase II study aiming to assess the clinical and biological impact of an investigational drug (NP137) when added to standard PD-1/PD-L1 blockade therapy in advanced or metastatic solid tumors with various sensitivity to anti-PD-1/PD-L1. Approximately 87 participants will be enrolled.
Baseline Eligibility Criteria include, but are not limited to:
- Histologically confirmed locally advanced / metastatic solid tumors of any histological types
- Cohort 1 [Stable Disease]: Patients with a radiological documentation of stable disease according to RECIST V1.1 criteria following at least 12 weeks under standard anti PD-1/PD-L1 therapy *
- Cohort 2 [primary refractory]: Patients with documented radiological progressive disease according to RECIST V1.1 but with clinical benefit under anti PD-1/PD-L1 standard therapy *
- Cohort 3 [secondary refractory]: Patients with documented radiological progressive disease following an initial Objective Response according to RECIST V1.1, with clinical benefit under standard anti-PD-1/PD-L1 *
- Refractory cohorts
- Evidence of clinical benefit according to investigator assessment.
- Absence of symptoms and signs indicating unequivocal progression of disease,
- Absence of decline in ECOG PS that can be attributed to disease progression,
- Absence of tumor progression at critical anatomical sites that cannot be managed by protocol-allowed medical interventions.
- At least one lesion measurable and evaluable as per RECIST V1*
- Presence of at least one tumor lesion with a diameter ≥10 mm (≥20mm in case of a single biospsiable and RECIST 1.1 target lesion) *
Contact: FAYETTE Jerôme, MD at 4 78 78 51 03 ext +33 (telephone) or jerome.fayette@lyon.unicancer.fr (email); To view specific contact information for each site, click here.
Location: University Medical Center Groningen (Groningen, Netherlands)
Brief description: This is a Phase II study with the anti-PD-L1 antibody atezolizumab and the anti-TIGIT antibody tiragolumab in patients with advanced or metastatic MSI-H cancer and patients with a locally advanced or metastatic solid tumor who, in the opinion of the investigator, based on available clinical data, may benefit from treatment with anti-PD-L1 and anti-TIGIT. Approximately 97 participants will be enrolled.
Baseline Eligibility Criteria include, but are not limited to:
- Cohort 2: patients with metastatic MSI-H tumors
- Cohort 4: patients with a locally advanced or metastatic solid tumor for whom, based on available clinical data, treatment with anti-PD-L1 immunotherapy may be beneficial
- Measurable disease, as defined by RECIST v1.1. Previously irradiated lesions should be discarded as target lesions *
- No prior immune checkpoint inhibitor treatment, including but not limited to anti-PD1 and anti-PD-L1 antibodies
Contact: Study Contact: Derk-Jan de Groot, MD, PhD at +31503612821 (telephone) or +31 50 361 6161 (telephone) or d.j.a.de.groot@umcg.nl (email); Study Contact Backup: Daan G Knapen, MD at d.g.knapen@umcg.nl
Location: Department of Hematology-Oncology, National University Hospital (Singapore)
Brief Description: This is a Phase II study of a neural network-based treatment decision support tool in patients with refractory solid organ malignancies. DRUID combines predictive models and public databases related to multi-gene markers, drug response screens, gene essentiality and clinical status of drugs to provide drug recommendations personalized based on an input genomic profile. Approximately 37 participants will be enrolled.
Baseline Eligibility Criteria include, but are not limited to:
- Histological or cytological diagnosis solid organ malignancy
- At least 1 measurable tumour lesions based on RECIST 1.1 criteria *
- Progressive disease from last line of therapy
- Has received at least 2 lines of palliative systemic therapy with no available standard therapy
- No concurrent administration of any other tumour therapy
Contact: Robert John Walsh at 69082222 (telephone) or robert_walsh@nuhs.edu.sg (email)
Phase II Study of PRL3-ZUMAB in Advanced Solid Tumors (NCT04118114)
Location: National Cancer Center Singapore (Singapore)
Brief description: This is a Phase II study of an investigational drug (PRL3-ZUMAB) monotherapy in patients with advanced solid tumours that have failed standard therapy. Approximately 10 participants will be enrolled.
Baseline Eligibility Criteria include, but are not limited to:
- Histopathological- or cytological- documented advanced curatively unresectable solid tumors failing standard therapy.
- For other solid tumours must have failed at least 1 line of standard therapy.
- Progressive disease following the last treatment
- Evaluable or measurable disease by RECIST v1.1 *
Contact: Study Contact: Matthew Ng, MD at 6436 8000 (telephone) or matthew.ng.c.h@singhealth.com.sg (email)
Clinical Trials Not Yet Recruiting
A Study of Phase2, IMC-001 In Patients With Metastatic Or Locally Advanced TMB-H Solid Tumor (TMB-H) (NCT06365840) (NOT YET RECRUITING)
Location: No location data
Brief description: This is a Phase II study to determine the efficacy of an investigational drug (IMC-001) in metastatic or locally advanced TMB-H solid tumor patients. Approximately 30 participants will be enrolled.
Baseline Eligibility Criteria include, but are not limited to:
- Documented Tumor Mutation Burden (TMB):≥ 16 mut/Mb
- Histologically or cytologically proven metastatic or locally advanced solid tumors.The participant must have at least one measurable tumor lesion per RECIST 1.1 *
- No previously treatment with an anti-PD-L1 or anti-PD-1 antibody
Contact: Study Contact: SUNGYOUNG LEE at +82 2 6283 5068 (telephone) or sylee@immuneoncia.com (email)
ACPMP Note: It is our understanding that this trial will only enroll 3 patients per 3 months for approximately the first 9 months.
MEDI5752 in Patients With Mature Tertiary Lymphoid Structures Solid Tumors. (TAYLOR) (NCT05888857) (NOT YET RECRUITING)
Location: Institut Bergonie (Bordeaux, France)
Brief Description: This is a Phase II trial assessing the efficacy of an investigational drug (MEDI5752) in patients with mature tertiary lymphoid structures advanced solid tumors. There will be included in two independent cohorts: Cohort A: patients with TLS+ IO-naïve solid tumor (miscellaneous) and Cohort B: patients with TLS+ PD1/PDL1-experienced solid tumor (miscellaneous). Approximately 102 participants will be enrolled.
Baseline Eligibility Criteria include, but are not limited to:
- Histologically confirmed solid tumor
- IO-naïve patients (cohort A) OR patients with secondary resistance to PD1/PDL1 inhibitors (cohort B),
- Patients in cohort B:
- Have to be diagnosed previously treated with PD-L1/PD-1 inhibitors (investigational or approved)
- Must have experienced initial clinical benefit (stable disease or better) from checkpoint inhibitor therapy for at least 4 months in which there was at least one interval scan prior to 4 months demonstrating no progression of disease.
- Presence of mature tertiary lymphoid structures (TLS)
- Advanced unresectable or metastatic solid disease,
- Measurable disease according to RECIST v1.1 *
- At least one tumor site that can be biopsied
- Disease progression on prior treatment, or previously untreated disease with no available acceptable treatment. Note that no more than three lines of systemic treatment for metastatic disease are allowed and that patients with oncogenic addiction must have progressed on prior approved regimens
Contact: Study and Institut Contact: Antoine ITALIANO, MD, PhD at +33556333333 (telephone) or a.italiano@bordeaux.unicancer.fr (email); Study Contact Backup: Simone MATHOULIN-PELISSIER, MD, PhD at s.mathoulin@bordeaux.unicancer.fr (email)
MUC1 Therapeutic Tumor Vaccine in Advanced Solid Cancers (NCT05986981) (NOT YET RECRUITING)
Location: Peking Union Medical College Hospital (Beijing, China)
Brief Description: This is a Phase II study of a therapeutic MUC1 cancer vaccine for the treatment of advanced solid tumors. A dose-escalation trial is being conducted to evaluate the safety and tolerability of the cancer vaccine in subjects with advanced solid tumors and to preliminarily evaluate the efficacy of the tumor vaccine. Approximately 20 participants will be enrolled.
Baseline Eligibility Criteria include, but are not limited to:
- Advanced subjects with histologically or cytologically proven advanced solid tumors who have failed standard multiline therapy
- At least one measurable lesion (i.e., mass ≥ 10 mm in diameter and malignant lymph node ≥ 15 mm in short diameter on enhanced scan with layer thickness ≤ 5 mm on spiral CT) according to the efficacy evaluation criteria for solid tumors, RECIST version 1.1 (see Appendix 4, Criteria for Evaluating the Efficacy of Solid Tumor Treatments) *
- No skin conditions that may prevent intradermal vaccine from reaching the target area
- No need for concomitant use of steroidal hormonal medications; exceptions may be made for those requiring topical or inhaled steroids
Contact: Fang Li, MD, at +86-010-69154417 (telephone) or lifang@pumch.cn (email)
The Prospective Clinical Study of Precision PRaG Therapy in Elderly Patients With Advanced Solid Malignant Tumors (PRaG9.0) (NCT06112041) (NOT YET RECRUITING)
Location: Second Affiliated Hospital of Soochow University (Suzhou, China)
Brief Description: This is a Phase II study of hypofractionated radiotherapy combined with PD-L1 inhibitor sequential GM-CSF and thymopentin for treatment of elderly patients with advanced solid tumors, when the HER-2 positive patients are treated with extra antibody-drug conjugate.
Baseline Eligibility Criteria include, but are not limited to:
- Aged 75 years and above
- Standard treatment is ineffective (disease progresses after treatment) or locally advanced or metastatic malignant solid tumor patients who cannot tolerate standard therapy, cannot receive or do not have standard therapy
Contact: Liyuan Zhang, doctor at 0512-67784829 (telephone) or zhangliyuan126@126.com (email)
PHASE 2/3 CLINICAL TRIALS
Specific Tumor Mutations/Characteristics
Trials in U.S.
Location:Multiple UK sites with various recruitment statuses. To view specific locations, click here.
Brief Description: DETERMINE is a Phase II/III study to evaluate the efficacy of licensed targeted therapies in rare adult, paediatric and teenage/young adult (TYA) cancers with actionable genomic alterations, including common cancers with rare actionable alterations.Rare is defined generally as incidence less than 6 cases in 100,000 patients or common cancers with rare alterations. Approximately 825 participants will be enrolled.
Baseline Eligibility Criteria include, but are not limited to:
- Any patient with histologically proven locally advanced or metastatic cancer (solid tumour or hematological malignancy) who has:
- exhausted (or declined) standard-of-care treatment options.
- or for whom no effective standard treatment is available
- and whose disease has progressed, or is refractory.
- Patients with objectively evaluable or measurable disease, according to an assessment method appropriate for their cancer type
- No participation in another interventional clinical trial, whilst taking part in this trial.
- Participation in an observational trial which does not involve administration of an Investigational Medicinal Product (IMP) and which, in the opinion of the local Investigator, would not place an unacceptable burden on the patient would be acceptable e.g. sample collection or Quality of Life (QoL) studies.
- for paediatric patients participating in other studies involving tissue/circulating tumour (ct) DNA/other blood collection, consideration would need to be given to the total blood volumes collected (as per the European Medicines Agency blood volume limits for children).
- No co-administration of anti-cancer therapies other than those in this trial
- Experimental: Treatment Arm 2: Atezolizumab
- Adult, teenage/young adults (TYA) and paediatric participants with high tumour mutational burden (TMB) or microsatellite instability high (MSI-high) or proven (previously diagnosed) constitutional mismatch repair deficiency (CMMRD) only.
- Experimental: Treatment Arm 4: Trastuzumab in combination with pertuzumab
- Adult, teenage/young adult (TYA) and paediatric participants with malignancies with HER2 amplification or activating mutations.
- Experimental: Treatment Arm 5: Vemurafenib in combination with cobimetinib
- BRAF V600 mutation-positive malignancies occurring in adults only.
Contact: Study Contact: Aida Sarmiento Castro at +442034695101 (telephone) or determine@cancer.org.uk (email); To view specific contact information for each site, click here.
Solid Tumors Generally (Appendix cancer, including mucinous, is considered a solid tumor.)
Trials in U.S.
Location: The Second Affiliated Hospital of Guangzhou Medical University (Guanzhou, Guangdong, China)
Brief description: This is a Phase II/III study designed to investigate the safety, response rates and survival outcomes of patients with advanced solid tumors by trans-artery/intra-tumor infusion of PD1/PDL1 antibody and/or CTLA4 antibody ipilimumab plus chemotherapeutic drug and to compare their differences. Approximately 200 participants will be enrolled.
Baseline Eligibility Criteria include, but are not limited to:
- Cytohistological confirmation is required for diagnosis of cancer
- At least one tumor lesion meeting measurable disease criteria as determined by RECIST v1.1 *
Contact: Hospital Study Contact: Zhenfeng Zhang, MD,PhD at 02034153532 (telephone) or zhangzhf@gzhmu.edu.cn (email); Study Contact Backup: Deji Chen, MD,PhD at chendeji2003@163.com (email)
PHASE 3
Appendix Cancer-Specific
Trials in U.S.
Study to Evaluate the Non-inferiority of Low-dose HIPEC Versus High-dose HIPEC in the Treatment of PMP (HIPEC-PMP) (HIPEC-PMP) (NCT06513065)
Location: Peritoneal Malignancy Institute Basingstoke - Hampshire Hospitals NHS Foundation Trust (Basingstoke, Hampshire, United Kingdom)
Brief description: This is a Phase III study to evaluate the non-inferiority of HIPEC with mitomycin C 10 mg/m2 for 60 minutes versus HIPEC with mitomycin C 35mg/m2 for 90 minutes in the treatment of pseudomyxoma peritonei From perforated epithelial mucinous tumours of the appendix. Approximately 176 participants will be enrolled.
Baseline Eligibility Criteria include, but are not limited to:
- Clinical and/or radiological diagnosis of pseudomyxoma peritonei from a primary mucinous epithelial tumours of the appendix (low and high grade)
- The extent of intraperitoneal disease must be deemed to be amenable to complete cytoreduction (CC0-1, i.e. residual disease of < 2.5mm in diameter).
- No patients who have previously undergone cytoreductive surgery and/or intraperitoneal chemotherapy.
Contact: Study Contact : Chris Wignall at 023 8120 5154 (telephone) or C.M.Wignall@soton.ac.uk (email); Study Contact Backup: Karen Martin at K.S.Martin@soton.ac.uk (email); Hampshire Contact: Faheez Mohamed at Faheez.Mohamed@hhft.nhs.uk (email)
OTHER
Appendix Cancer-Specific
Trials in U.S.
Gastrointestinal Microbiome Study of Appendiceal Cancer (NCT02599116)
Location: Mercy Medical Center (Baltimore, Maryland)
Brief description: This study analyzes the gastrointestinal microbiome of appendiceal cancer patients with peritoneal spread scheduled to undergo cytoreductive surgery with hyperthermic intraperitoneal chemotherapy (CRS/HIPEC). Participants will provide fecal samples pre- and post-operatively.
Baseline Eligibility Criteria include, but are not limited to:
- Diagnosis of appendiceal cancer with peritoneal spread
- Candidate for cytoreductive surgery with hyperthermic intraperitoneal chemotherapy (CRS/HIPEC)
- ≥18 and ≤ 80 years of age
- Eastern Cooperative Oncology Group performance status score of ≤2/Karnofsky performance status (KPS) ≥70%
- Signed Institutional Review Board approved informed consent
Contact: Study Contact: Mary Caitlin King, at 410-332-9294 (telephone) or mking5@mdmercy.com (email)
Location: RWJBarnabas Health and Rutgers Cancer Institute of New Jersey (Livingston and New Brunswick, New Jersey)
Brief description: This clinical trial collects biospecimen samples to create a personalized ctDNA test to guide treatment for patients with gastrointestinal cancer with peritoneal carcinomatosis. Deoxyribonucleic acid, or DNA, is the material that carries all the information about how a living thing will work and function. Everyone is born with the same DNA in all our cells throughout our body. Sometimes, some of the cells in the body develop abnormalities in the DNA that cause those cells to grow abnormally and uncontrollably. Cancer occurs when there is abnormal and uncontrolled growth of cells. The DNA in cancer cells is therefore different from the DNA someone is born with.
The Signatera ctDNA assay is a laboratory test that takes tumor (cancer) tissue and evaluates it for unique tumor DNA. This evaluation is used to create a report (otherwise known as an assay) personalized to each person's cancer. The personalized assay creates a personalized blood test to detect the level of abnormal DNA from the cancer that may be circulating in the body. Once this personalized blood assay is designed, it may be used to monitor a person's blood for the presence of ctDNA, which will indicate the presence or absence of cancer over time, even after treatment.
Baseline Eligibility Criteria include, but are not limited to:
- Patients with histologically confirmed carcinoma of presumed gastrointestinal origin (gastric, esophageal, colorectal, appendiceal, hepatobiliary or peritoneal carcinomatosis of apparent GI primary) with documented diffuse peritoneal carcinomatosis, either by conventional imaging studies, positive ascitic fluid analysis, or surgical staging
- Measurable or evaluable disease by cross-sectional imaging studies
- Patients must be candidates for possible surgical cytoreduction (with or without HIPEC) as determined by a study surgical oncologist
- Age >= 18 years
- Estimated life expectancy of at least 12 months
- Eastern Cooperative Oncology Group (ECOG) performance status =< 2
- Patients must sign informed consent
- Be willing to present for medical exams, blood draws and imaging as scheduled in protocol
- Be able to donate two 10 mL tubes of blood every 3 months
- Women of childbearing potential will undergo routine screening evaluation for pregnancy prior to enrollment and be managed per standard of care
Contact: Study Contact: Henry Richard Alexander, MD, at 732-235-3391 (telephone) or ha364@cinj.rutgers.edu (email)
Clinical Trials Not Yet Recruiting
EQUITY GI: A Prospective Study to Enhance Quality, Inclusivity, and Trial Participation in Black Patients With Gastrointestinal Cancer (NCT06263088) (NOT YET RECRUITING)
Location: University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center (Cleveland, Ohio)
Brief description: This research study is being conducted to improve the quality of care of participants who have a diagnosis of gastrointestinal cancer (anal, colon, rectal, esophageal, stomach, small bowel, appendix, pancreas, gall bladder, liver, neuroendocrine tumor of gastrointestinal origin).
Baseline Eligibility Criteria include, but are not limited to:
- Newly diagnosed Black GI cancer participants irrespective of stage. Eligible tumor types include anal carcinoma, rectal cancer, colon cancer, small bowel cancer, appendix carcinoma, hepatobiliary cancer, pancreatic cancer, gastroesophageal cancer, gastrointestinal neuroendocrine tumors, and gastrointestinal stromal tumor.
Contact: Study Contact: Sakti Chakrabarti, MD, at 216-844-3951 (telephone) or sakti.chakrabarti@uhhospitals.org (email)
Solid Tumors Generally (Appendix cancer, including mucinous, is considered a solid tumor.)
Trials in U.S.
Location: xCures (Oakland, California)
Brief description: The primary objective of this study, sponsored by Travera Inc. in Massachusetts, is to validate whether the mass response biomarker has potential to predict response of patients to specific therapies or therapeutic combinations using isolated tumor cells from various specimen formats including malignant fluids such as pleural effusions and ascites, core needle biopsies, fine needle aspirates, or resections.
Baseline Eligibility Criteria include, but are not limited to:
- Diagnosis of any kind of carcinoma
- Malignant fluid (e.g. pleural effusion or ascites) drainage OR tumor tissue resection OR tumor tissue needle biopsy is clinically indicated as part of SOC
- Proceeding onto therapy for treatment
- Informed consent obtained for the XCELSIOR longitudinal outcomes registry (NCT03793088)
Contact: Study Contact: Sarah Ginn, at (707) 641-4475 (telephone) or traverastudy@xcures.com (email)
Trials Outside of U.S.
Target-specific immunoPET Imaging of Digestive System Carcinoma (NCT06715839)
Location: Renji Hospital, School of Medicine, Shanghai Jiao Tong University (Shanghai, Shanghai, China)
Brief description: The aim of this study is to establish and optimize the target-specific PET/CT imaging method, and its physiological and pathological distribution characteristics, on the basis of which the diagnostic efficacy of the above imaging agents in digestive system malignant tumors will be evaluated.
Baseline Eligibility Criteria include, but are not limited to:
- Aged 18-75 years old and of either sex；
- Histologically confirmed diagnosis of digestive system carcinoma or suspected digestive system carcinoma by diagnostic imaging;
Contact: Study Contact: Weijun Wei, Ph.D. & M.D., at 15000083153 (telephone) or wwei@shsmu.edu.cn (email)
Location: Multiple sites in Switzerland. To view specific locations, click here.
Brief description: This is a Phase 4 study to test if adding the mistletoe extract Iscador® Qu to regular cancer treatment with immune checkpoint inhibitors affects the immune system's ability to fight cancer, safety of the treatment, how well the treatment performs against cancer, and how the patient feels during treatment. Approximately 100 participants will be enrolled.
Baseline Eligibility Criteria include, but are not limited to:
- Locally advanced non-operable or metastatic solid tumor
- Eligible for routine (standard) treatment with immune checkpoint inhibitor (+/- chemo/targeted therapy)
- Must be eligible for treatment with mistletoe preparations
Contact: Study Contact: Mascha Binder, Prof. Dr. at +41 61 265 50 75 (telephone) or mascha.binder@unibas.ch (email); Study Contact Backup: Benjamin Kasenda, PD Dr. Dr. at Benjamin.Kasenda@usb.ch (email); To view specific contact information for each site, click here.
Other – Virtual Tumor Board Recommended Therapies/Clinical Trials Based on Genomic Sequencing Done as Part of this Study
Trials in U.S.
TCF-001 TRACK (Target Rare Cancer Knowledge) Study (TRACK) (NCT04504604)
Location: Virtual/Remote (Sponsor, Target Cancer Foundation, is located in Cambridge, Massachusetts)
Brief Description: Study of whether patients with rare cancer can benefit from matched molecular therapy as recommended by next-generation sequencing results. This study involves the genomic profiling by Foundation Medicine of the patient’s tumor tissue and plasma circulating cell-free DNA. The results of that Foundation Medicine testing are provided to the patient’s treating physician and the sponsor of this study (i.e., Target Cancer Foundation). Target provides these findings to the study’s Virtual Molecular Tumor Board for analysis. The Tumor Board then provides a written report of its findings and recommendations to the patient’s treating physician with recommended treatments or relevant clinical trials. The patient’s treating physician and patient determine whether to act on those recommendations.
Baseline Eligibility Criteria include but are not limited to:
- Willingness to provide tissue and blood samples for Foundation One testing. Note: If patient has already had qualifying Foundation One tissue testing done, it must have been conducted on tissue that is no more than 18 months old.
Contact: Mary Oster – Mary@targetancerfoundnation.org; 617-299-0389
FOOTNOTES
* This requirement pertains to a standard for ensuring that there is measurable disease. The purpose of this is to make the measurement and tracking of the disease's response to the investigational treatment during the clinical trial. Some patients with appendiceal cancer patients have disease but it cannot be reliably measured and thus perhaps may not be eligible.
** Due to the sheer number and limited focus of Phase 1 solid tumor trials, we have not included new Phase 1 solid tumor trials in this update and will likely not be including them going forward. We have instead focused the solid tumor trials on Phase 2 and beyond.