Evaluating RAS(ON) Inhibitors for Gastrointestinal Solid Tumors
Official title: A Platform Study of RAS(ON) Inhibitors in Patients With Gastrointestinal Solid Tumors
Run by Revolution Medicines, Inc. · NCT06445062 · Data updated 2026-11-12
This study is testing new RAS(ON) inhibitors combined with standard treatments to see if they can help people with certain types of gastrointestinal cancers that have RAS mutations.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 1130 (estimated) |
| Sponsor | Revolution Medicines, Inc. Industry-sponsored |
| Drugs / interventions | cetuximab |
| Locations | 32 sites (Chandler, Arizona and 31 other locations) |
| Status | Recruiting |
| Started | May 24, 2024 |
| Main results expected | September 30, 2028 |
| Study ends | March 30, 2030 |
| Registry record updated | September 22, 2026 |
| Trial ID | NCT06445062 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 and older with RAS-mutated colorectal or pancreatic cancers that are unresectable or metastatic.
✕Probably not a fit
Patients with primary central nervous system tumors or significant gastrointestinal function impairment may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This platform study aims to assess the safety, tolerability, pharmacokinetics, and preliminary antitumor activity of novel RAS(ON) inhibitors in combination with standard care or other novel agents for patients with RAS-mutated gastrointestinal cancers. It includes multiple subprotocols targeting colorectal cancer and pancreatic ductal adenocarcinoma, allowing for a flexible approach to treatment combinations. Patients will be enrolled based on specific RAS mutations and treatment history, with the goal of determining the recommended phase 2 dose and schedule for these therapies.
Why it matters
Potential benefit: If successful, this study could provide new treatment options for patients with RAS-mutated gastrointestinal cancers, potentially improving outcomes.
How similar studies have gone: Other studies have shown promise with similar approaches targeting RAS mutations, indicating potential for success in this novel treatment strategy.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: All Patients (unless otherwise noted): * ≥ 18 years of age * ECOG PS is 0 to 1 * Adequate organ function as outlined by the study * Pathologically or cytologically documented pancreatic carcinoma or poorly differentiated pancreatic carcinoma with metastatic disease or RAS-mutated, histologically or cytologically confirmed colorectal adenocarcinoma with documented unresectable or metastatic disease (Subprotocol A, B, C and G) * Presence of RAS G12D mutation (Subprotocol D, E, F, G) Exclusion Criteria: All Patients: * Primary central nervous system (CNS) tumors * Impaired gastrointestinal (GI) function that may significantly alter the absorption of RMC drugs * Major surgery within 28 days of first dose Other inclusion/exclusion criteria may apply.
Where it's running
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Ironwood Cancer and Research Centers
Chandler, Arizona, United States Recruiting -
Mayo Clinic Hospital
Phoenix, Arizona, United States Recruiting -
HonorHealth Research Institute
Scottsdale, Arizona, United States Recruiting -
UC San Diego Moores Cancer Center
La Jolla, California, United States Recruiting -
Cedars-Sinai Cancer at Cedars-Sinai Medical Center
Los Angeles, California, United States Recruiting -
UCLA Hematology/Oncology- Santa Monica
Los Angeles, California, United States Recruiting
Show 26 more locations
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University of Colorado Hospital-Anschutz Cancer Pavilion
Aurora, Colorado, United States Recruiting -
Yale-New Haven Hospital-Yale Cancer Center
New Haven, Connecticut, United States Recruiting -
Mayo Clinic Cancer Center
Jacksonville, Florida, United States Recruiting -
Moffitt Cancer Center
Tampa, Florida, United States Recruiting -
The University of Kansas Clinical Research Center
Westwood, Kansas, United States Recruiting -
The Sidney Kimmel Comprehensive Cancer Center at John Hopkins
Baltimore, Maryland, United States Recruiting -
Massachusetts General Hospital
Boston, Massachusetts, United States Recruiting -
Dana Farber Cancer Institute
Boston, Massachusetts, United States Recruiting -
Mayo Clinic
Rochester, Minnesota, United States Recruiting -
Nebraska Cancer Specialists
Omaha, Nebraska, United States Recruiting -
University of Nebraska Medical Center
Omaha, Nebraska, United States Recruiting -
Atlantic Health System
Morristown, New Jersey, United States Recruiting -
Northwell Health / RJ Zuckerberg Cancer Center
Lake Success, New York, United States Recruiting -
Columbia University Medical Center
New York, New York, United States Recruiting -
Memorial Sloan Kettering Cancer Center Main Campus
New York, New York, United States Recruiting -
Duke University Medical Center
Durham, North Carolina, United States Recruiting -
University of Cincinnati Medical Center
Cincinnati, Ohio, United States Recruiting -
Stephenson Cancer Center
Oklahoma City, Oklahoma, United States Recruiting -
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States Recruiting -
SCRI Oncology Partners
Nashville, Tennessee, United States Recruiting -
Baylor College of Medicine
Houston, Texas, United States Recruiting -
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States Recruiting -
NEXT Oncology Dallas
Irving, Texas, United States Recruiting -
Huntsman Cancer Institute, University of Utah
Salt Lake City, Utah, United States Recruiting -
Virginia Cancer Specialists
Fairfax, Virginia, United States Recruiting -
Fred Hutchinson Cancer Center
Seattle, Washington, United States Recruiting
Study contacts
- Study coordinator: Revolution Medicines
- Email: medinfo@revmed.com
- Phone: 1-844-2-REVMED
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.