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Evaluating RAS(ON) Inhibitors for Gastrointestinal Solid Tumors

A Platform Study of RAS(ON) Inhibitors in Patients With Gastrointestinal Solid Tumors

PHASE1; PHASE2 · Revolution Medicines, Inc. · NCT06445062

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
Enrollment1130 (estimated)
Ages18 Years and up
SexAll
SponsorRevolution Medicines, Inc. (industry)
Drugs / interventionscetuximab
Locations32 sites (Chandler, Arizona and 31 other locations)
Trial IDNCT06445062 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with RAS-mutated colorectal or pancreatic cancers that are unresectable or metastatic.

Not a fit: Patients with primary central nervous system tumors or significant gastrointestinal function impairment may not benefit from this study.

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 performed: Other studies have shown promise with similar approaches targeting RAS mutations, indicating potential for success in this novel treatment strategy.

Eligibility criteria

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, and C)
* Presence of RAS G12D mutation (Subprotocol D, E, F)

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 this trial is running

Chandler, Arizona and 31 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Colorectal Cancer, CRC, Pancreatic Ductal Adenocarcinoma, PDAC, Gastrointestinal Cancer, Metastatic Pancreatic Ductal Adenocarcinoma, RAS Mutation, KRAS G12X

Last reviewed 2026-05-15 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.