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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)
Phase: Phase 1
Location: Houston Methodist Hospital (Houston, Texas)
Brief Description: This study will evaluate the safety and efficacy of NALIRIFOX per NAPOLI-3 regimen as first-line chemotherapy for patients with advanced small intestine and appendiceal cancers. Female or male patients aged 18 years, or older, with histopathologically or cytologically confirmed advanced mucinous or non-mucinous appendix cancer or advanced small intestine cancer will be eligible for participation in the study.
Baseline Eligibility Criteria include, but are not limited to:
- Histopathologically or cytologically confirmed advanced mucinous or non-mucinous appendix cancer or advanced small intestine cancer.
- Measurable disease per the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1*.
- Eastern Cooperative Oncology Group performance status of 0 or 1.
Contact: Maen Abdelrahim, MD,PhD at 713-441-1240 (telephone) or mabdelrahim@houstonmethodist.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)
Clinical Trials Not Yet Recruiting
Safety and Efficacy of PIPAC Using Single Agent Mitomycin in Solid Tumors (NCT07487168)
Phase: Phase 1
Location: Moffitt Cancer Center (Tampa, Florida, United States)
Brief Description: This Phase 1 dose-escalation study will evaluate the safety, tolerability, and recommended Phase 2 dose (of pressurized intraperitoneal aerosol chemotherapy with mitomycin C (PIPAC-MMC) for patients with unresectable peritoneal carcinomatosis from gastrointestinal primaries (colorectal, high-grade appendiceal, or small bowel). Up to three PIPAC procedures are planned at 8-week intervals while patients continue 5-fluorouracil/leucovorin (5-FU/LV) between procedures.
Baseline Eligibility Criteria include, but are not limited to:
- Participants must have histologically confirmed peritoneal disease from colorectal, small bowel, or high grade appendiceal adenocarcinoma. High grade appendiceal cancers include moderate or poorly differentiated mucinous or non-mucinous adenocarcinoma, signet ring cell adenocarcinoma, or goblet cell adenocarcinoma. This can be established by image guided biopsy, diagnostic laparoscopy, or previous surgery.
- Patients must be ineligible for CRS/HIPEC through one of the following criteria: a) PCI score ≥16. b) Inability to achieve complete cytoreduction due to extent of disease. c) Significant small bowel involvement precluding a complete CRS. d) Unresectable disease in porta hepatis, pelvic side wall or other critical structure. e) Patients who decline invasive cytoreduction.
- Participants must have completed at least 4 months of first-line systemic therapy (5-FU based approach with or without biologic therapy).
Contact: Valentina Diaz Aranzazu at 813-745-8536 (telephone) or valentina.diazaranzazu@moffitt.org (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.
Phase: Phase 1
Location: Multiple places in the US. See exact locations here.
Brief Description: This study aims to evaluate the effects of rezatapopt on the pharmacokinetics of metformin, rosuvastatin, repaglinide, and midazolam in patients with advanced solid tumors harboring a TP53 Y220C mutation.
Baseline Eligibility Criteria include, but are not limited to:
- Confirmed locally advanced or metastatic solid malignancy with a TP53 Y220C mutation identified through a tumor-tissue based (e.g., FoundationOneCDx, PathGroup, Caris WES, MSK IMPACT, TEMPUS) or a liquid-biopsy based (e.g., Caris, MSK Access) NGS molecular test.
Contact: SCRI Medical Support Center at 1-615-329-7286 (telephone) or SCRI.InnovationsMedical@scri.com (email)
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)
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)
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)
Study of RMC-5127 in Patients With Advanced KRAS G12V-Mutant Solid Tumors (NCT07349537)
Phase: Phase 1
Location: Multiple places in the US. See exact locations here.
Brief Description: The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary antitumor activity of RMC-5127 as a monotherapy and in combination with either daraxonrasib or cetuximab in adults with KRAS G12V-mutant solid tumors.
Baseline Eligibility Criteria include, but are not limited to:
- Pathologically documented, locally advanced or metastatic KRAS G12V-mutated solid tumor malignancy.
- Received and progressed or been intolerant to prior standard therapy (including targeted therapy) appropriate for tumor type and stage.
- Measurable per RECIST v1.1*
- Able to take oral medications.
Contact: Revolution Medicines Study Director at 1-844-2-REVMED (telephone) or medinfo@revmed.com (email)
Phase: Phase 1
Location:D3 Bio Investigative Site 1402 (San Antonio, Texas, United States)
Brief Description: This is a first-in-human (FIH) multicenter, open-label, dose-escalation Phase 1 clinical trial to evaluate safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary efficacy of D3S-003 in participants with advanced KRAS p.G12D mutant solid tumors
Baseline Eligibility Criteria include, but are not limited to:
- Subjects with histologically confirmed locally advanced, recurrent, or metastatic malignancy that has progressed following at least one line of standard therapy or where standard therapy is ineffective, intolerable, or inappropriate, or where participation in a clinical trial of an investigational agent is considered a standard therapeutic option.
- Subjects must have documented KRAS p.G12D mutation by a local test from tumor tissue or blood collected within the last 5 years.
- Subjects must have measurable disease per RECIST v1.1.*
Contact: Medical Director at +86 21 61635900 (telephone) or D3bio_CT@d3bio.com (email)
Phase: Phase 1
Location: Multiple places in the US. See exact locations here.
Brief Description: The main purpose of the trial is to assess whether the trial drug, KST-6051, is safe and tolerable when administered orally to adults with advanced or metastatic solid tumors with certain KRAS mutations.
Baseline Eligibility Criteria include, but are not limited to:
- Histologically documented locally advanced, unresectable, or metastatic solid tumor (or other specified cancers)
- Documentation of KRAS mutation prior to the first dose of trial drug(s)
- Progressed on or intolerant to standard treatment(s)
- Measurable disease at baseline per RECIST 1.1.*
Contact: Kestrel Therapeutics, Inc. at 617-612-6810 (telephone) or clinicaltrials@kestreltherapeutics.com (email)
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)
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.
A Phase I Clinical Study of HRS-7058 in Patients With Advanced Malignant Tumour (NCT06383871)
Location:Tianjin Medical University Cancer Institute and Hospital (Tianjin, Tianjin Municipality, China)
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)
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)
Imatinib and Trametinib for KRAS-mutated Solid Tumor (NCT06962254)
Phase: Phase 1
Location: China Medical University Hospital (Taichung, Taiwan)
Brief Description: In this Phase 1, participants with unresectable solid cancers harboring KRAS G12 mutations will be provided with a compassionate treatment if their diseases progress after current standard treatments, or there is no available standard treatment. This trial will evaluate the efficacy and safety of the combination of trametinib and imatinib on chemotherapy refractory solid cancers.
Baseline Eligibility Criteria include, but are not limited to:
- Histologically confirmed locally advanced or metastatic solid tumors with KRAS a G12X mutation (i.e., any mutation occurring at codon 12 of the KRAS gene).
- Documented disease progression during or within 6 months after standard chemotherapies or no available standard therapy.
- Documented measurable disease as defined by RECIST v1.1.
- Participant has life expectancy of at least 8 weeks.
Contact: Study Contact: JLi-Yuan Bai at +886-975-680-928 (telephone) or lybai6@gmail.com (email)
Clinical Trials Not Yet Recruiting
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)
A Study of DCTY1102 Injection in Patients With Advanced Solid Tumors (NCT07014878)
Phase: Phase 1
Location: First Medical Center of Chinese PLA General Hospital (Beijing, China)
Brief Description: This study is an open-label, single-arm, multicenter Phase I clinical trial consisting of a dose-escalation phase (Phase Ia) and a cohort-expansion phase (Phase Ib).
Phase Ia (Dose Escalation) aims to evaluate the safety and tolerability of DCTY1102 Injection in patients with advanced solid tumors positive for KRAS G12D mutation and HLA-A*11:01 genotype, observe potential dose-limiting toxicities (DLTs), determine the maximum tolerated dose (MTD) and/or recommended Phase II dose (RP2D), characterize the pharmacokinetic (PK) profile of DCTY1102 following infusion, assess its in vivo proliferation and persistence, preliminarily evaluate therapeutic efficacy, and investigate immunogenicity.
Phase Ib (Cohort Expansion) will be conducted after establishing MTD and/or RP2D in Phase Ia. This phase further evaluates the preliminary efficacy, safety, PK profile, and immunogenicity of DCTY1102 Injection in patients with KRAS G12D mutation-positive, HLA-A*11:01 genotype tumors, including colorectal cancer, pancreatic cancer, or other malignancies. The study plans to establish 2-3 cohorts:
Cohort 1: Colorectal cancer
Cohort 2: Pancreatic cancer
Cohort 3: Other tumor types
Each cohort will enroll approximately 15-31 patients who will receive DCTY1102 infusion at the MTD and/or RP2D dose levels identified in Phase Ia.
Baseline Eligibility Criteria include, but are not limited to:
- Age:18 ≤ Age ≤ 75 years
- Patients with histologically or cytologically confirmed unresectable locally advanced or metastatic solid tumors, who have experienced failure of standard treatment (disease progression after treatment or intolerable toxic side effects), have no standard treatment available, for whom standard treatment is not applicable at present, or who refuse standard treatment.
- Have at least one measurable lesion (according to RECIST v1.1).
- The prescreening must meet the following two criteria simultaneously: HLA-A 11:01 genotype, and not carrying the HLA-A 68:01 subtype; Positive for the tumor KRAS G12D mutation.
Contact: Shengjie Sun MD, PhD at 0086-010-66939409 (telephone) or ssjdoctor@163.com (email)
TCR-T Cell Therapy for KRAS Mutation in Advanced Solid Tumors (NCT07342738)
Phase: Phase 1
Location: Sun Yat-sen University Cancer Center (Guangzhou, Guangdong, China)
Brief Description: This is a single-arm, Multicenter, open-label clinical study aimed at evaluating the safety and efficacy of TCR-T injection in patients with advanced solid tumors induced by KRAS mutations.
Baseline Eligibility Criteria include, but are not limited to:
- Subjects with advanced solid tumors confirmed by histology/cytology, have failed with standard treatment, or intolerant to standard treatment, or no standard treatment exists：1）Colorectal cancer：failed or intolerant to at least two lines of standard treatment.2）Non-small cell lung cancer：Absence of the following gene mutations (Epidermal Growth Factor Receptor[EGFR]、Anaplastic Lymphoma Kinase[ALK] 、 Proto-oncogene tyrosine-protein kinase 1[ROS1]) and having failed or intolerant to platinum-based chemotherapy and/or immunotherapy and/or anti-angiogenic therapy.3）Other advanced solid tumor: failed with standard treatment, or intolerant to standard treatment, or no standard treatment exist.
- At least one measurable lesion (according to Response Evaluation Criteria in Solid Tumors[RECIST], version 1.1*);
- Patients with tumor tissue or peripheral blood testing positive for KRAS-G12V or G12D mutations and expression of matching HLA-A*11:01 or HLA-C*01:02 subtypes;
- ECOG (Eastern Cooperative Oncology Group)≤2;
- Life expectancy ≥3 months;
Contact: Yu-hong Li, MD, Ph D at 87342487 ext 020 (telephone) or liyh@sysucc.org.cn (email)
KRAS and EGFR Mutations
Trials in U.S.
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)
Phase: Phase 1
Location: University of Texas MD Anderson Cancer Center (Houston, Texas, United States)
Brief Description: The goal of this clinical trial is to learn if AN9025 is safe and tolerable to treat solid cancer tumors with specific genetic mutations. It will help identify doses for use in future testing and establish the safety profile of the drug. The main questions it aims to answer are:
Which dose(s) of AN9025 are safe and tolerable for use in evaluating anti-tumor activity in participants with Rat Sarcoma oncogene (RAS) mutated solid tumors? What medical problems do participants have when taking AN9025?
Baseline Eligibility Criteria include, but are not limited to:
- Have histological or cytological evidence of a diagnosis of cancer that is advanced and/or metastatic with progression after treatment with available standard therapies.
- Documentation of KRAS/NRAS/HRAS mutation determined by validated local testing of tumor tissue or circulating free DNA (cfDNA) in a certified laboratory.
- Have consented to provide archival tumor tissue collected within 5 years or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated.
Contact: Clinical Trial Manager at 848 230-7430 (telephone) or AN9025S0101@adlainortye.com (email)
KRAS or BRAF Mutations
Trials in U.S.
BRAF
Trials Outside of U.S.
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)
Clinical Trials Not Yet Recruiting
Phase: Phase 1
Location: Multiple places in the US. See exact locations here.
Brief Description: This is a Phase 1, two-part, open-label, nonrandomized, dose-escalation and signal-seeking study of an investigational drug, evaluating the safety, tolerability, PK, pharmacodynamic (what the drug does to the body), and its antitumor in adult participants with advanced solid tumors harboring PIK3CA mutations. [Margaret, note mutation above for purposes of filing in database]
Baseline Eligibility Criteria include, but are not limited to:
- Histologically confirmed advanced solid tumor harboring oncogenic PIK3CA mutations.
- Phase 1b Cohort 1: endometrial cancer with PIK3CA mutation.
- Phase 1b Cohort 2: HR-positive/HER2-negative or HER2-low breast cancer.
- Phase 1b Cohort 3: all other solid tumors not meeting criteria for Cohorts 1 or 2.
- Prior treatment: refractory, intolerant, or not appropriate for standard-of-care therapy.
- At least one measurable lesion per RECIST v1.1.*
Contact: Cogent Biosciences, Inc at 6179455576 (telephone) or trialinfo@cogentbio.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)
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.
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 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.
A Study to Find a Suitable Dose of ASP5834 in Adults With Solid Tumors (NCT07094204)
Phase: Phase 1
Location: Multiple sites in the U.S.. To view specific locations, click here.
Brief Description: The main aims of this study are to check the safety of ASP5834 given by itself or given with panitumumab, and how well it is tolerated; and to find a suitable dose of ASP5834 given by itself or given with panitumumab.
Baseline Eligibility Criteria include, but are not limited to:
- Participant has histologically confirmed locally advanced (unresectable) or metastatic solid tumor malignancy with a documented KRAS G12V, G12D, G12C, G12R, G12A or G13D mutation or KRAS amplification (copy number >/= 4) determined by local testing.
- For a participant with a documented KRAS amplification, only those with no other co-occurring KRAS mutation or those with a co-occurring KRAS G12V, G12D, G12C, G12R, G12A or G13D mutation are eligible.
- Unique to Europe (EU): Only participants who have pre-existing local results can be enrolled.
- For the ASP5834 monotherapy dose escalation part, any histologically confirmed locally advanced (unresectable) or metastatic solid tumor malignancy is eligible. Participant must have received prior standard therapy in the advanced setting, and the investigator does not see any further clinical benefit from continuing such therapy or the participant is ineligible to receive or has refused standard approved therapies.
Contact: Astellas Pharma Global Development, Inc. at 800-888-7704 (telephone) or Astellas.registration@astellas.com (email)
Trials Outside of U.S.
A Study of DEG6498 in Participants With Solid Tumors (NCT07244835)
Phase: Phase 1
Location: Sun Yat-Sen University Cancer Center (Guangzhou, Guangdong, China)
Brief Description: The goal of this first in human, Phase 1, multi-center, open-label, and 2-part study is to learn whether DEG6498 is safe and tolerable in participants with advanced solid tumors. It will also learn about DEG6498 pharmacokinetics (PK) profile and potential antitumor activity. The main questions it aims to answer are:
- what is an appropriate dose to be given to participants?
- are the side effects of treatment manageable?
Participants who are treated in this study will receive DEG6498 orally once a day and be closely monitored by the treating physicians.
Baseline Eligibility Criteria include, but are not limited to:
- Patients with advanced solid tumors, who have failed standard therapies, or for whom no standard therapy exists
- Part 1: Advanced solid tumor patients
- Part 2: Patients with BRAF mutation positive tumors and HCC
- Presence of at least 1 measurable lesion according to RECIST v1.1.*
Contact: Degron Therapeutics Co. at +86-21-60799565 (telephone) or clinicaltrials@degrontx.com (email)
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: 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.
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)
A Phase 1/2a Study of VS-7375 in Patients With KRAS G12D-Mutated Solid Tumors (NCT07020221)
Phase: Phase 1/2
Location: Multiple sites in the U.S.. To view specific locations, click here.
Brief Description: This study will assess the safety and efficacy of VS-7375 alone and in combination in patients with advanced solid tumors harboring a KRAS G12D-mutation.
Baseline Eligibility Criteria include, but are not limited to:
- Histologic or cytologic evidence of locally advanced unresectable or metastatic solid tumor harboring a KRAS G12D mutation.
- Must have received ≥1 prior line of standard systemic therapy for advanced or metastatic disease or experienced cancer progression within 6 months of neoadjuvant or adjuvant therapy.
- Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.*
Contact: Verastem Call Center at 1 781 292 4204 (telephone) or clinicaltrials@verastem.com (email)
Phase: Phase 1/2
Location: Fairfax, Virginia
Brief Description: This is a study to evaluate the safety and potential anti-tumor activity of an investigational agent called ARV-806 in Adults with Advanced Cancer having a specific KRAS mutation. This is an open-label study which means that participants and study staff will know that all participants will receive ARV-806.
Researchers think that ARV-806 can work by breaking down a specific protein with a mutation that is present in some tumors, which might help prevent or slow tumors from growing. This will be the first time ARV-806 will be used in people.
This study will include 2 parts.
In Part A (Phase 1), different small groups of participants will receive lower to higher doses of ARV-806. Adults with advanced cancers having a specific KRAS mutation will be included.
In Part B (Phase 2), participants will be assigned to receive one of up to 2 dose levels decided by the information from Part A. Part B will include participants with advanced pancreatic ductal cancer having a specific KRAS mutation.
Baseline Eligibility Criteria include, but are not limited to:
Part A:
- Histological or cytological diagnosis of unresectable or metastatic solid tumor malignancy, AND
- Must have evidence of KRAS G12D mutation in tumor tissue or blood (ctDNA), AND
- Must have received prior standard-of-care (SOC) therapy appropriate for their type and stage of disease and have no other available treatment options with curative intent, or, in the opinion of the investigator, would be unlikely to tolerate or derive clinically meaningful benefit from appropriate SOC therapy, AND
- Must have at least 1 measurable lesion
Part B (does not include appendiceal cancer patients):
- Histological or cytological diagnosis of unresectable or metastatic PDAC with KRAS G12D mutation status confirmed by local testing of tumor tissue using a validated molecular or next-generation sequencing (NGS) testing, AND
- Must be willing to provide archival tumor tissue or willing to undergo pretreatment biopsy, AND
- Must have received at least one prior standard of care systemic therapy for PDAC (systemic therapy received in the neoadjuvant or adjuvant setting is allowed), AND
- Participants must have at least 1 measurable lesion
Contact: Arvinas, Inc. at +14752245787 (telephone) or clinicaltrialsARV-806@arvinas.com (email)
Trials Outside of U.S.
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
Phase: Phase 1/2
Location: Multiple sites in China. To view specific locations, click here.
Brief Description: This is a multicenter, open-label, phase I/IIa to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and preliminary antitumor activity of the investigational drug JAB-23E73 in patients with advanced solid tumors harboring KRAS mutations or amplification. The study consists of 2 phases: Phase 1 Dose Escalation and Phase IIa Dose Expansion.
Baseline Eligibility Criteria include, but are not limited to:
- Histological or cytologically proven diagnosis of a locally advanced, unresectable, and/or metastatic solid tumor cancer with evidence of KRAS gene alteration (including gene mutation and wild type amplification).
- Able to provide an archived tumor tissue sample or fresh biopsy sample.
- Life expectancy ≥3 months at the start of treatment.
- ≥1 measurable lesion per RECIST v1.1.
- Able to swallow oral medications or with gastrointestinal dysfunction and no gastrointestinal disease that significantly alters the absorption of medication
Contact: Study Contact: Jacobio Pharmaceuticals at 86 10 56315466 (telephone) or clinicaltrials@jacobiopharma.com (email); To view specific contact information for each site, click here.
Phase: Phase 1/2
Location: Multiple places in China. See exact locations here.
Brief Description: This is a multicenter, open-label phase 1/2 study consisting of two parts: dose escalation phase and dose expansion phase. The objective of the dose escalation phase is to evaluate the safety, tolerability and pharmacokinetics of HYP-2090PTSA in patients with advanced solid tumors harboring KRAS mutation and to determine the RP2D. In the dose expansion phase, preliminary efficacy and safety at the RP2D will be further explored in patients with specific cancer harboring KRAS p.G12C mutation.
Baseline Eligibility Criteria include, but are not limited to:
- Subjects with histologically or cytologically confirmed locally advanced or metastatic advanced solid tumors;
- Subjects must have at least one measurable lesion as defined by RECIST v1.1*;
Contact: Kai Chang at +86-028-86021875 (telephone) or kai.chang4086@huiyupharma.com (email)
A Phase I/II Study of ABSK141 in Patients With Advanced Solid Tumors ( ABSK141-101) (NCT07417189)
Phase: Phase 1/2
Location: Fudan University Shanghai Cancer Center (Shanghai, China)
Brief Description: This is a first-in-human (FIH), exploratory, multicenter, open-label, phase I/II study of ABSK141 in patients with advanced solid tumors to evaluate safety, tolerability, PK and optimize the dosage.
Baseline Eligibility Criteria include, but are not limited to:
- Histologically confirmed locally-advanced or metastatic solid tumors.
- KRAS G12D mutation
- At least one measurable target lesion according to RECIST 1.1.*
Contact: Yu Zhang, Bachelor at +86-021-68912098 (telephone) or yuco.zhang@abbisko.com (email)
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)
KRAS and BRAF mutations
Trials in U.S.
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.
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)
Gene Therapy for HER-Positive Cancer (SENTRY-HER2) (SENTRY-HER2) (NCT07192432)
Phase: Phase 1/2
Location: Multiple places in the US. See exact locations here.
Brief Description: This is a Phase 1/2, first-in-human, open-label, dose-escalating and expansion trial designed to assess the safety and efficacy of VNX-202 in patients with HER2 positive cancers.
Baseline Eligibility Criteria include, but are not limited to:
- Part 1: presence of advanced or metastatic disease that has progressed during or following previous treatment
- Part 2: Early stage HER-2 positive cancers with high risk for relapse following completion of standard of care or after neoadjuvant systemic treatment
Contact: Allen Reha at 908-938-6019 (telephone) or allen.reha@vironexis.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.
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)
A Study of ART0380 for the Treatment of Advanced or Metastatic Solid Tumors (NCT04657068)
Phase: Phase 1/2
Location: Multiple sites in the U.S. and other countries. To view specific locations, click here.
Brief Description: This clinical trial is evaluating a drug called ART0380 in participants with advanced or metastatic solid tumors. The main goals of this study are to:
Find the recommended dose of ART0380 that can be given safely to participants alone and in combination with gemcitabine or irinotecan
Learn more about the side effects of ART0380 alone and in combination with gemcitabine or irinotecan
Learn more about the effectiveness of ART0380 alone and in combination with gemcitabine or irinotecan
Baseline Eligibility Criteria include, but are not limited to:
- If patients have a known germline BRCA mutation or a cancer with a somatic BRCA mutations or which is HRD positive and for which there is an approved PARP inhibitor, participants should have received such treatment before participating in the study unless contra-indicated
- At least 1 radiologically evaluable lesion (measurable and/or non-measurable) that can be assessed at baseline and is suitable for repeated radiological evaluation by RECIST v1.1 or Prostate Cancer Working Group-3 Guidelines (PCWG-3)
- Non-irradiated tumor tissue sample (archival or newly obtained core biopsy of a tumor lesion) available for submission for analysis.
Contact: Sarah Cannon Development Innovations at 844-710-6157 (telephone) or SCRI.InnovationsMedical@scri.com (email)
Phase: Phase 1/2
Location: Multiple sites in the U.S.. To view specific locations, click here.
Brief Description: This study, the first clinical trial of AVZO-1418, aims to determine the safety, tolerability, pharmacokinetics, pharmacodynamics, maximum tolerated dose, and antitumor activity of AVZO-1418 when administered intravenously as a monotherapy and potentially in combination therapy to patients with locally advanced or metastatic epithelial solid tumors.
Baseline Eligibility Criteria include, but are not limited to:
- Patients with histologically or cytologically confirmed locally advanced/metastatic malignancies for tumor types of preferred indications:
o Locally advanced or metastatic epithelial solid tumors (as specified in the protocol). - Measurable disease as assessed by Investigator using RECIST v1.1.*
- Agree to provide molecular test report results to confirm eligibility and archival tumor samples and/or fresh biopsy, as applicable.
Contact: Medical Information at (858) 239-2944 (telephone) or ClinicalTrials@avenzotx.com (email)
Trials Outside of U.S.
Personalized Neoantigen Peptide Vaccines for Solid Tumors (NCT07002203)
Phase: Phase 1/2
Location: Horizon Cancer Excellence Center, Bumrungrad International Hospital (Bangkok, Thailand)
Brief Description: This clinical trial is studying the safety and efficacy of a personalized cancer vaccine called a neoantigen peptide vaccine in patients with solid tumors. These vaccines are custom-made for each patient using specific mutations (neoantigens) found in their own tumor. The goal is to help the patient's immune system recognize and attack their cancer.
Baseline Eligibility Criteria include, but are not limited to:
- Age: 20 years or older.
- Language proficiency: Able to read and understand Thai clearly.
- Life expectancy: Estimated to be at least 6 months from the date of consent.
- Eligibility from prior research: Must have participated in the SQK01-002A research project and have tumor tissue confirmed as suitable for neoantigen peptide vaccine production.
- Cancer diagnosis: Clinically and pathologically confirmed cancer diagnosis, with supporting radiological evidence.
- Cancer stage-specific criteria:
- Advanced cancer: Suitable for immune checkpoint inhibitors (ICIs) and shows resistance to prior therapies, with measurable lesions based on mRECIST1.1 criteria.
- Early-stage cancer: High recurrence risk despite prior surgery and/or radiotherapy, with no current adjuvant treatment standard.
- menopause for more than 12 months, or being over 60 years of age.
Contact: Harit Suwanrusme, M.D. at +6689-181-1800 (telephone) or doctorharit@gmail.com (email)
A Study of MHB048C in Patients With Advanced Solid Tumors (NCT07192120)
Phase: Phase 1/2
Location: Fudan University Shanghai Cancer Center (Shanghai, Shanghai Municipality, China), Guangdong Provincial People's Hospital (Guangzhou, Guangdong, China)
Brief Description: This is a first-in-human, open-label, multicenter Phase I/II study of MHB048C in patients with advanced solid tumors. The study was designed to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of MHB048C monotherapy.
Baseline Eligibility Criteria include, but are not limited to:
- Histologically or cytologically confirmed advanced solid tumors that are refractory to standard therapy, intolerant to standard therapy, or have no standard treatment options.
- At least one measurable lesion per RECIST v1.1* criteria or one bone.
- Adequate bone marrow reserve and organ function.
Contact: CMO / Senior Vice President of R&D at 86 0571-86963293 (telephone) or jwshi@minghuipharma.com (email)
Phase: Phase 1/2
Location: Fudan University Shanghai Cancer Center (Shanghai, China)
Brief Description: This study adopts a multi-center, open-label, non-randomized trial design. It plans to enroll patients with Advanced solid tumor. Dose-escalation and PK-expansion studies will be carried out to evaluate the safety, tolerability, and preliminary efficacy of sirolimus (albumin-bound) in combination with Different ADCs (DP303c/SYS6043/SYS6002/SYS6010) in this patient population, and to confirm the recommended phase 2 dose (RP2D).
Baseline Eligibility Criteria include, but are not limited to:
- Subjects aged 18 to 75 years (inclusive).
- 2. Patients with advanced solid tumors that are unresectable or metastatic and confirmed by histology or cytology.
- 3. At least one measurable lesion, as defined by RECIST 1.1* criteria.
- 4. Willing to provide samples of previously removed tumors or undergo fresh tumor biopsy.
Contact: Clinical Trials Information Group officer at 86-0311-69085587 (telephone) or ctr-contact@cspc.cn (email)
Clinical Trial of VBC103 in Patients With Advanced Malignant Solid Tumors (NCT07299747)
Phase: Phase 1/2
Location: Fudan University Shanghai Cancer Center (Shanghai, Shanghai Municipality, China)
Brief Description: This study is a multicenter, open-label, multi-dose, first-in-human (FIH) Phase I/IIa study to determine the safety and tolerability of VBC103, as well as the maximum tolerated dose (MTD) and/or recommended Phase II dose (RP2D), PK and further evaluate its efficacy.
Baseline Eligibility Criteria include, but are not limited to:
- Histologically or cytologically confirmed unresectable advanced/metastatic solid tumor that has recurred or progressed during or after standard systemic therapy, or is intolerant to standard therapy, or lacks standard treatment options (applicable only to Phase I and Phase IIa Cohort 5).
- At least one measurable lesion as assessed by the investigator per RECIST v1.1.*
Contact: Jian Zhang at 021-64175590 (telephone) or syner2000@163.com (email)
An Phase Ib/II Clinical Trial of TCC1727 Combination Therapy in Advanced Solid Tumors (NCT07371663)
Phase: Phase 1/2
Location: Multiple places in China. See exact locations here.
Brief Description: This is a Phase Ib/II clinical study. The Phase Ib dose-escalation study aims to evaluate and determine the recommended Phase II dose (RP2D) of TCC1727 in combination with benmelstobart /olaparib /topotecanfor patients with advanced solid tumors.
Baseline Eligibility Criteria include, but are not limited to:
- Subjects must have histologically or cytologically confirmed advanced or metastatic solid tumors and have experienced disease progression following prior standard anti-tumor therapy; or subjects must have no available standard therapy, be intolerant to or refuse standard therapy, or meet the specific requirements for the corresponding phase and group as follows:
- Phase Ib: Subjects with advanced, recurrent, or refractory solid tumors, which may include (but are not limited to) the specific tumor types in Phase II
- Phase II Study: Based on different combination therapy groups
Contact: Zhengbo Song at +86 13857153345 (telephone) or songzb@zjcc.org.cn (email)
Phase: Phase 1/2
Location: District One Hospital (Beijing, Beijing Municipality, China)
Brief Description: This Phase 1/2 study evaluates the safety, feasibility, and preliminary anti-tumor activity of allogeneic donor-derived CAR-NK cells in participants with advanced solid tumors. The CAR target antigen is selected for each participant after tumor profiling using a tissue biopsy and/or liquid biopsy. Participants will receive either a single-target or dual-target CAR-NK product based on the antigen profile.
Baseline Eligibility Criteria include, but are not limited to:
- Histologically or cytologically confirmed advanced/unresectable or metastatic solid tumor that is relapsed/refractory after standard therapy, or no standard therapy available.
- Targetable antigen positivity from the protocol target menu based on tissue biopsy and/or liquid biopsy platform (as defined in the lab manual).
- Arm assignment rules:
- Arm A: ≥1 antigen meets "positive" threshold
- Arm B: ≥2 antigens meet "positive" threshold
- At least one measurable lesion by RECIST 1.1.*
Contact: Rhoda M Smith, PHD at +12077706670 (telephone) or clinical-trials@essen-biotech.com (email)
Phase: Phase 1/2
Location: District One Hospital (Beijing, Beijing Municipality, China)
Brief Description: This Phase 1/2 study evaluates the safety, tolerability, and preliminary anti-tumor activity of EBNK-001 (allogeneic NK cells) given after lymphodepleting cyclophosphamide/fludarabine (CY/FLU) and supported with low-dose IL-15, administered either alone or in combination with pembrolizumab in adults with advanced/metastatic solid tumors. The study will determine a recommended Phase 2 dose (RP2D) and explore signals of clinical activity using RECIST-based* response criteria.
Baseline Eligibility Criteria include, but are not limited to:
- Histologically confirmed advanced/metastatic solid tumor that is relapsed/refractory after standard therapy (or no standard therapy available).
- Measurable disease per RECIST v1.1* (or iRECIST if applicable).
Contact: Rhoda M Smith, PHD at +12077706670 (telephone) or clinical-trials@essen-biotech.com (email)
Carbon Nanoparticle-Loaded Iron in the Treatment of Advanced Solid Tumor (NCT07433283)
Phase: Phase 1/2
Location: Multiple places in China. See exact locations here.
Brief Description: CNSI-Fe, developed by Sichuan Yingrui Pharmaceutical Technology Co., Ltd., is an innovative anti-cancer drug with Fe²⁺ (oxidized iron) as the active ingredient that exerts anti-tumor effects by regulating the ferroptosis pathway and enhancing tumor targeting through nanocarbon-mediated delivery. Following a Phase I dose-escalation trial in 16 patients with advanced solid tumors in China, CNSI-Fe showed good safety and tolerability, with one dose-limiting toxicity, partial or complete responses in 2 patients, and a disease control rate of 87%, supporting the planned Phase Ib/IIa study to further evaluate its safety, pharmacokinetics, and preliminary efficacy.
Baseline Eligibility Criteria include, but are not limited to:
- Histologically or cytologically confirmed advanced solid tumor
- At least one measurable lesion according to RECIST v1.1* that has not recently undergone radiotherapy or tissue biopsy (unless progression after radiotherapy)
- Lesions must be injectable, either directly or via medical imaging guidance, as judged suitable by the investigator
Contact: Xiaohai Tang, PhD & MD at +86 13880881962 (telephone) or pharmmateceo@enraypharm.com (email)
A Phase Ib/II Study of 7MW3711 Combined With JS207 in Advanced Solid Tumors (NCT07466160)
Phase: Phase 1/2
Location: Shanghai Chest Hospital (Shanghai, Shanghai Municipality, China)
Brief Description: This study was designed to evaluate the efficacy and safety of 7MW3711 in combination with JS207 in subjects with solid tumor.
Baseline Eligibility Criteria include, but are not limited to:
- Histologically or cytologically confirmed locally advanced or metastatic solid tumor, progressive after last treatment received and who progressed on or after standard therapies or intolerant to approved therapies or who lack efficient standard therapies
- Histologically or cytologically confirmed locally advanced or metastatic selected advanced solid tumors
- Measurable or evaluable disease by RECIST v1.1.*
Contact: Shun Lu, Doctor at 021-22200000 ext 3121 (telephone) or shun_lu@hotmail.com (email)
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: Allegheny Health Network West Penn Hospital (Pittsburgh, Pennsylvania)
Brief Description: This research study aims to improve the treatment of Peritoneal Carcinomatosis (PC), a condition where cancer spreads within the abdomen. Patients with PC often experience significant pain and nutritional problems. Currently, there isn't a standard treatment approach, and doctors use different combinations of chemotherapy, surgery, and methods to deliver chemotherapy directly into the abdomen (intra-peritoneal or "IP" chemotherapy).
The study will compare two IP chemotherapy methods: HIPEC and PIPAC. HIPEC involves circulating heated chemotherapy through the abdomen during surgery, while PIPAC delivers chemotherapy as a pressurized aerosol during a laparoscopic procedure. Both methods aim to achieve the same goal, but they haven't been directly compared to see which is safer, more tolerable, more effective, and provides better value.
Baseline Eligibility Criteria include, but are not limited to:
- Biopsy-proven or clinically suspected peritoneal carcinomatosis
- Receipt of at least three months of standard systemic chemotherapy prior with persistence of disease at the time of randomization
- Not a candidate for surgical cytoreduction at the time of laparoscopy
Contact: Patrick Wagner, MD at 412-359-3731 (telephone) or patrick.wagner@ahn.org (e-mail)
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.
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
[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
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)
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.
Phase: Phase 2
Location: Multiple sites in the U.S.. To view specific locations, click here.
Brief Description: This phase II trial studies if talazoparib works in patients with cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) and has mutation(s) in deoxyribonucleic acid (DNA) damage response genes who have or have not already been treated with another PARP inhibitor. Talazoparib is an inhibitor of PARP, a protein that helps repair damaged DNA. Blocking PARP may help keep cancer cells from repairing their damaged DNA, causing them to die. PARP inhibitors are a type of targeted therapy. All patients who take part on this study must have a gene aberration that changes how their tumors are able to repair DNA. This trial may help scientists learn whether some patients might benefit from taking different PARP inhibitors "one after the other" and learn how talazoparib works in treating patients with advanced cancer who have aberration in DNA repair genes.
Baseline Eligibility Criteria include, but are not limited to:
- Adult patients with solid tumors and documented germline or somatic aberrations in genes involved in DNA damage response (DDR) and whose disease has progressed following at least one standard therapy or who have no acceptable standard treatment options. Molecular testing performed at an National Cancer Institute-Molecular Analysis for Therapy Choice (NCI-MATCH) (NCT02465060) study-designated Clinical Laboratory Improvement Act (CLIA) laboratory or at Myriad Genetics, GeneDx, Invitae, or the Frederick National Laboratory for Cancer Research (FNLCR) Molecular Characterization Laboratory (MoCha) will be acceptable for determination of eligibility
- Patients with the following germline or somatic genetic aberrations will be eligible based on compelling preclinical and/or clinical data suggesting that these deleterious mutations confer sensitivity to PARP inhibitors; no more than 6 patients (across both cohorts) with an eligibility mutation in any one gene will be enrolled
- Deleterious BRCA1 or BRCA2 mutations
- Loss of function mutations (including novel loss of function frameshift or nonsense mutations) in the following Fanconi anemia genes: FANCA, FANCB, FANCC, FANCD2, FANCE, FANCF, FANCG, FANCI, FANCJ, FANCL, FANCM, FANCN
- A known functional mutation (including novel loss of function frameshift or nonsense mutations) in any of the following DDR genes: ARID1A, ATM, ATR, BACH1 (BRIP1), BAP1, BARD1, CDK12, CHK1, CHK2, IDH1, IDH2, MRE11A, NBN, PALB2, RAD50, RAD51, RAD51B, RAD51C, RAD51D, RAD54L
- Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension
- Patients must have a tumor site amenable to biopsy. If avoidable, the lesion for biopsy should not be selected as a target lesion for RECIST measurements
- Patients must be able to swallow whole tablets or capsules. Nasogastric or gastric-tube (G-tube) administration is not allowed. Any gastrointestinal disease which would impair ability to swallow, retain, or absorb drug is not allowed
- Patients must have recurrent, locally advanced or metastatic disease
- Patients must have progressed on or after at least one line of standard-of-care (SOC) intervention, except for those patients without SOC or for whom talazoparib is SOC
Contact: See locations.
Trials Outside of U.S.
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 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.
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: 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.
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.
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)
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)
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
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)
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. 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: 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)
Location: Multiple locations in Korea. To view specific locations, click here.
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.
Phase: Phase 2
Location: Cancer Hospital, Shantou University Medical College (Shantou, Guangdong, China)
Brief Description: Preclinical and clinical evidence suggests that intestinal low-dose radiotherapy (ILDR) may enhance antitumor immune responses by modulating the gut microenvironment, thereby improving the efficacy of immune checkpoint inhibitors (ICBs) in refractory solid tumors. Based on these findings, the investigators initiate a multicohort phase II clinical trial to evaluate the clinical benefit and safety of ILDR combined with PD-1/PD-L1 monoclonal antibody therapy in patients with metastatic solid tumors resistant to prior ICB treatment.
Baseline Eligibility Criteria include, but are not limited to:
- At least one accessible and measurable lesion should be selected as the target lesion for observation according to RECIST* criteria.
- 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.
- Patients should not be considered eligible for surgical treatment.
- Patients have complete clinical and pathological information.
- Patients should not be bothered by any psychological, family, social or geographical conditions that may hinder compliance with the research protocol.
Contact: Chuangzhen Chen, MD at +86 13923995569 (telephone) or czchen2@stu.edu.cn (email)
Immunotherapy With Adaptive Pulse Radiotherapy in Solid Tumors (I-APT) (NCT07381231)
Phase: Phase 2
Location: Samsung Medical Center (Seoul, South Korea)
Brief Description: The goal of this clinical trial is to find out whether Adaptive Pulse Radiotherapy (Pulse RT) combined with immune checkpoint inhibitors (ICIs) helps treat advanced solid tumors.
It will also check how safe this combined treatment is and how it affects the immune system and quality of life.
Baseline Eligibility Criteria include, but are not limited to:
- Currently receiving or planned to receive immune checkpoint inhibitor therapy.
- At least one lesion suitable for radiotherapy and measurable per RECIST 1.1.*
Contact: Nalee Kim, MD, PhD at 82-2-3410-2612 (telephone) or nalee.kim@samsung.com (email)
Phase II Study of LM-24C5 (NCT07387081)
Phase: Phase 2
Location: Multiple places in China. See exact locations here.
Brief Description: This study is to evaluate the efficacy and safety of LM-24C5 in combination with other therapies in subjects with CEACAM5-positive advanced solid tumor. (CEACAM5 is a tumor marker found in some appendiceal cancers.)
Baseline Eligibility Criteria include, but are not limited to:
- Histologically or cytologically confirmed recurrent or refractory advanced solid tumors, or lack/intolerance of standard therapy
- CEACAM5-positive
- At least one evaluable lesion
Contact: Mengmeng Liu at +8613918118040 (telephone) or mengmengliu@lanovamed.com (email)
Clinical Trials Not Yet Recruiting
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)
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
BRAF
Clinical Trials Not Yet Recruiting
Phase: Phase 2/3
Location: Multiple places in the UK. See exact locations here.
Brief Description: This clinical trial is looking at two drugs called dabrafenib and trametinib. Dabrafenib and trametinib are approved as standard of care treatment for adult patients with melanoma (a type of skin cancer) or lung cancer and in children with glioma (a type of brain tumour). This means they have gone through clinical trials and been approved by the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK. Dabrafenib and trametinib work in patients with a particular mutation in their cancer known as BRAF V600.
Baseline Eligibility Criteria include, but are not limited to:
- Confirmed diagnosis of a malignancy harboring an oncogenic BRAF V600 alteration, including Langerhans cell histiocytosis, using an analytically validated next-generation sequencing method.
- Previous treatment with dabrafenib and trametinib in combination (or other BRAF and MEK inhibitors in combination) for the current indication.
- Any impairment of gastrointestinal (GI) function of uncontrolled GI disease that may significantly alter the administration or absorption of dabrafenib and/or trametinib (e.g. history of diverticulitis, metastases to the GI tract, uncontrolled Crohn's disease, uncontrolled ulcerative diseases, uncontrolled nausea, vomiting, diarrhoea, malabsorption syndrome or short gut syndrome).
Contact: Aida Sarmiento Castro at +44 207 242 0200 (telephone) or determine@cancer.org.uk (email)
Other 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)
Trials Outside of U.S.
Phase: Phase 2/3
Location: Multiple sites in the United Kingdom. To view specific locations, click here.
Brief Description: This is a Phase 2/3 clinical trial, looking at a drug called capmatinib. Capmatinib is approved as standard of care treatment for adult patients with certain types of lung cancer. This means it has gone through clinical trials and been approved by the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK.
Capmatinib works in lung cancer patients with a particular mutation in their cancer known as a METex14 skipping mutation.
Investigators now wish to find out if it will be useful in treating patients with other cancer types which have the same mutation or other specific mutations or changes which take place in the MET gene. If the results are positive, the study team will work with the NHS and the Cancer Drugs Fund to see if these drugs can be routinely accessed for patients in the future.
This trial is part of a trial programme called DETERMINE. The programme will also look at other anti-cancer drugs in the same way, through matching the drug to rare cancer types or ones with specific mutations.
Baseline Eligibility Criteria include, but are not limited to:
- Confirmed diagnosis of a MET-positive malignancy using an analytically validated next-generation sequencing method (METex14 skipping, MET amplification, MET fusion, or MET activating mutation).
- Patients must be able and willing to undergo a fresh biopsy at baseline and blood samples for translational research.
- No prior MET inhibitor or HGF-targeting therapy unless genetic profile demonstrates a behavior of resistance known to be potentially sensitive
- No impairment of gastrointestinal (GI) function or GI disease that may significantly alter the administration or absorption of capmatinib (e.g., Crohn's disease, ulcerative diseases, uncontrolled nausea, vomiting, diarrhoea, malabsorption syndrome or short gut syndrome). Unable to swallow capmatinib intact, without chewing or crushing the tablets (as per the dosing schedule).
Contact: Aida Sarmiento Castro at 02034695101 (telephone) or determine@cancer.org.uk (email)
Phase II/III Trial of PRL3-Zumab in Advanced Solid Tumor Patients (PRL3-zumab) (NCT07290088)
Phase: Phase 2/3
Location: Multiple places in Malaysia. See exact locations here.
Brief Description: This is a Multi-Center, Phase II/III, open-label, single dose level (6 mg/kg) basket trial of PRL3-zumab monotherapy in solid cancer patients.
Baseline Eligibility Criteria include, but are not limited to:
- Histopathological diagnosis and metastatic status cancer at study entry.
- Stage 1-3 patients with no more than 3 prior lines of treatment
- Measurable disease by iRECIST*.
- No history of active hepatitis B or C infection.
Contact: Ms Munirah Jamaluddin at +603-4041 2821 (telephone) or munirah.jamaluddin@myxmo.com.my (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)
Clinical Trials Not Yet Recruiting
Phase: Phase 2/3
Location: Multiple sites in the United Kingdom. To view specific locations, click here.
Brief Description: This is a Phase 2/3 clinical trial, looking at a drug called capmatinib. Capmatinib is approved as standard of care treatment for adult patients with certain types of lung cancer. This means it has gone through clinical trials and been approved by the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK.
Capmatinib works in lung cancer patients with a particular mutation in their cancer known as a METex14 skipping mutation.
Investigators now wish to find out if it will be useful in treating patients with other cancer types which have the same mutation or other specific mutations or changes which take place in the MET gene. If the results are positive, the study team will work with the NHS and the Cancer Drugs Fund to see if these drugs can be routinely accessed for patients in the future.
This trial is part of a trial programme called DETERMINE. The programme will also look at other anti-cancer drugs in the same way, through matching the drug to rare cancer types or ones with specific mutations.
Baseline Eligibility Criteria include, but are not limited to:
- Confirmed diagnosis of a MET-positive malignancy using an analytically validated next-generation sequencing method (METex14 skipping, MET amplification, MET fusion, or MET activating mutation).
- Patients must be able and willing to undergo a fresh biopsy at baseline and blood samples for translational research.
- No prior MET inhibitor or HGF-targeting therapy unless genetic profile demonstrates a behavior of resistance known to be potentially sensitive
- No impairment of gastrointestinal (GI) function or GI disease that may significantly alter the administration or absorption of capmatinib (e.g., Crohn's disease, ulcerative diseases, uncontrolled nausea, vomiting, diarrhoea, malabsorption syndrome or short gut syndrome). Unable to swallow capmatinib intact, without chewing or crushing the tablets (as per the dosing schedule).
Contact: Aida Sarmiento Castro at 02034695101 (telephone) or determine@cancer.org.uk (email)
Phase: Phase 3
Location: Multiple places in the US. See exact locations here.
Brief Description: This phase III trial studies how well pressurized intraperitoneal aerosolized chemotherapy (PIPAC) with mitomycin works versus (vs) standard chemotherapy (leucovorin calcium, fluorouracil, and irinotecan hydrochloride [FOLFIRI regimen] plus bevacizumab) in treating patients with appendix or colorectal cancer that cannot be removed by surgery (unresectable) and has spread from where it first started (primary site) to the abdominal cavity (peritoneal metastases).
Baseline Eligibility Criteria include, but are not limited to:
- Histologically or cytologically confirmed appendiceal or colorectal cancer peritoneal metastases
- No extraperitoneal metastases except lung ≤ 5 lesions with largest ≤ 1cm as identified on CT imaging or MRI
- Visible peritoneal metastatic disease on cross-sectional imaging or diagnostic laparoscopy
- Completed or progressed on first-line oxaliplatin-based systemic therapy, or intolerant without progression
- Not a candidate for cytoreductive surgery as determined by site investigator
Contact: Mustafa Raoof at 626-218-5484 (telephone) or mraoof@coh.org (email)
PHASE 4
Appendix Cancer-Specific
Trials in U.S.
Intraoperative Imaging of Gastrointestinal Malignancies Using Pafolacianine (CYTALUX™) (NCT07124351)
Phase: Phase 4
Location: Cedars-Sinai Medical Center (Los Angeles, California)
Brief Description: This is an open-label study in adults to determine feasibility of using CYTALUX™ (pafolacianine) injection with near-infrared (NIR) fluorescent imaging for detecting any type adenocarcinoma (gastric, esophageal and appendiceal).
Baseline Eligibility Criteria include, but are not limited to:
- Have a primary diagnosis, or a high clinical suspicion, of gastroesophageal adenocarcinoma based on CT (computed tomography)/PET (positron emission tomography) or other imaging (Cohort 1) or diagnosis of appendiceal adenocarcinoma with a high clinical suspicion of peritoneal carcinomatosis (Cohort 2)
- Have an indication for surgical intervention for gastroesophageal tumor resection or diagnostic laparoscopy for assessment of peritoneal disease burden
- Willingness to stop the use of folate, folic acid, or folate-containing supplements within 48 hours before administration of CYTALUX
Contact: Amy Hoang – amy.hoang@cshs.org, 310-423-1542 and Laura Sarmiento – laura.sarmiento@cshs.org; 310-423-4295
OTHER
Appendix Cancer-Specific
Trials in U.S.
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)
Clinical Trials Not Yet Recruiting
Solid Tumors Generally (Appendix cancer, including mucinous, is considered a solid tumor.)
Trials in U.S.
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.