Evaluating RMC-6236 for advanced solid tumors with specific RAS mutations
A Multicenter Open-Label Study of RMC-6236 in Patients With Advanced Solid Tumors Harboring Specific Mutations in RAS
PHASE1; PHASE2 · Revolution Medicines, Inc. · NCT05379985
This study is testing a new drug called RMC-6236 to see if it can help adults with advanced solid tumors that have certain RAS mutations.
Quick facts
| Phase | PHASE1; PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 754 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Revolution Medicines, Inc. (industry) |
| Locations | 16 sites (Orange, California and 15 other locations) |
| Trial ID | NCT05379985 on ClinicalTrials.gov |
What this trial studies
This Phase 1/1b multicenter open-label study aims to assess the safety, tolerability, pharmacokinetics, and clinical activity of RMC-6236, a RAS-MULTI(ON) inhibitor, in adults with advanced solid tumors that have specific RAS mutations. The study will involve escalating doses of the drug to determine the maximum tolerated dose and/or recommended phase 2 dose. Participants must have previously received standard therapy appropriate for their tumor type and stage, and their tumors must be confirmed to harbor specific KRAS or RAS mutations through DNA sequencing.
Who should consider this trial
Good fit: Ideal candidates include adults with advanced solid tumors, specifically those with KRAS G12 mutations or other RAS mutations, who have previously undergone standard therapy.
Not a fit: Patients with primary central nervous system tumors, active untreated brain metastases, or significant gastrointestinal impairments may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new targeted therapy option for patients with advanced solid tumors harboring specific RAS mutations.
How similar studies have performed: Other studies targeting RAS mutations have shown promise, indicating potential for success with this novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Histologically confirmed advanced solid tumor with specific KRAS G12 mutations (dose escalation) or RAS mutations (dose optimization/expansion) identified through deoxyribonucleic acid (DNA) sequencing. PDAC with wild-type RAS (expansion). * Treatment naive or have received prior standard therapy appropriate for tumor type and stage * Have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Adequate organ function Exclusion Criteria: * Primary central nervous system (CNS) tumors * Active, untreated brain metastases * Known or suspected impairment of gastrointestinal function that may prohibit ability to swallow or absorb an oral medication * History of any other unstable or clinically significant concurrent medical condition that would, in the opinion of the investigator, jeopardize the safety of a participant, impact their expected survival through the end of the study participation, and/or impact their ability to comply with the protocol prior/concomitant therapy Other inclusion/exclusion criteria may apply.
Where this trial is running
Orange, California and 15 other locations
- UC Irvine/Chao Family Comprehensive Cancer Center — Orange, California, United States (RECRUITING)
- UCLA — Santa Monica, California, United States (RECRUITING)
- Moffitt Cancer Center — Tampa, Florida, United States (RECRUITING)
- Johns Hopkins University — Baltimore, Maryland, United States (RECRUITING)
- Dana Farber Cancer Institute — Boston, Massachusetts, United States (RECRUITING)
- Perlmutter Cancer Center at NYU Langone Health — New York, New York, United States (RECRUITING)
- Memorial Sloan-Kettering Cancer Center — New York, New York, United States (RECRUITING)
- Columbia University — New York, New York, United States (RECRUITING)
- Christ Hospital Cancer Center — Cincinnati, Ohio, United States (RECRUITING)
- Sarah Cannon Research Institute — Nashville, Tennessee, United States (RECRUITING)
- University of Texas at Austin — Austin, Texas, United States (RECRUITING)
- Mary Crowley Cancer Research — Dallas, Texas, United States (RECRUITING)
- The University of Texas MD Anderson Cancer Center — Houston, Texas, United States (RECRUITING)
- Next Oncology — San Antonio, Texas, United States (RECRUITING)
- Huntsman Cancer Institute — Salt Lake City, Utah, United States (RECRUITING)
- Next Oncology Virginia — Fairfax, Virginia, United States (RECRUITING)
Study contacts
- Study coordinator: Revolution Medicines, Inc.
- Email: medinfo@revmed.com
- Phone: 1-844-273-8633
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Non-small Cell Lung Cancer, Colorectal Cancer, Pancreatic Ductal Adenocarcinoma, Advanced Solid Tumors, KRAS, Lung Cancer, Colon Cancer, Metastatic Cancer