Clinical trial Recruiting at 32 sites Phase1; Phase2 Interventional Ages 18 and up

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

PhasePhase1; Phase2
Study typeInterventional
Ages18 Years and up
SexAll
Enrollment1130 (estimated)
SponsorRevolution Medicines, Inc.
Industry-sponsored
Drugs / interventionscetuximab
Locations32 sites (Chandler, Arizona and 31 other locations)
StatusRecruiting
StartedMay 24, 2024
Main results expectedSeptember 30, 2028
Study endsMarch 30, 2030
Registry record updatedSeptember 22, 2026
Trial IDNCT06445062 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

  • 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
  • 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.