Study on RMC-6236 for Patients with Advanced Solid Tumors with Specific RAS Mutations
Sponsor: Revolution Medicines, Inc.
ClinicalTrials ID:NCT05379985
This clinical trial is testing a new drug, RMC-6236, to see if it is safe and well-tolerated in adults with advanced solid tumors that have specific RAS mutations. The study aims to find the best dose for future research.
Patient Parameters
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Program Overview
The purpose of this study is to evaluate the safety and effectiveness of a new drug called RMC-6236 in adults with advanced solid tumors that have specific mutations in the RAS gene. The study will test different doses of the drug to find the most effective and safest dose for patients. RMC-6236 is designed to target and inhibit the active form of the RAS protein, which is involved in the growth of certain cancers.
Description
This study is a Phase 1/2 trial conducted at multiple centers, where participants will receive an investigational drug called RMC-6236. The trial is open-label, meaning both the researchers and participants know what treatment is being given. The study will assess how safe and tolerable the drug is, how it behaves in the body, and its effects on the cancer. The goal is to determine the highest dose that can be given safely and to recommend a dose for future studies. RMC-6236 is taken orally and is designed to specifically target the active form of the RAS protein, which is often mutated in cancers like HRAS, NRAS, and KRAS.
Eligibility Criteria
Inclusion Criteria
- Have an advanced solid tumor confirmed by lab tests, with specific KRAS G12 mutations or other RAS mutations.
- Have not received treatment before or have already tried standard treatments for their type and stage of cancer.
- Be in good overall health with an ECOG performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
- Have adequate organ function as determined by medical tests.
Exclusion Criteria
- Have primary tumors in the central nervous system (CNS).
- Have active or untreated cancer that has spread to the brain.
- Have known or suspected issues with the digestive system that could affect the ability to swallow or absorb oral medication.
- Have any other serious or unstable medical conditions that could affect safety, survival, or ability to follow the study protocol.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| UC Irvine/Chao Family Comprehensive Cancer Center | 92868 | Orange | California |
| UCLA | 90404 | Santa Monica | California |
| Moffitt Cancer Center | 33612 | Tampa | Florida |
| Johns Hopkins University | 21287 | Baltimore | Maryland |
| Dana Farber Cancer Institute | 02215 | Boston | Massachusetts |
| Perlmutter Cancer Center at NYU Langone Health | 10016 | New York | New York |
| Memorial Sloan-Kettering Cancer Center | 10021 | New York | New York |
| Columbia University | 10032 | New York | New York |
| Christ Hospital Cancer Center | 45219 | Cincinnati | Ohio |
| Sarah Cannon Research Institute | 37203 | Nashville | Tennessee |
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