RMC-5127 for advanced cancers with KRAS G12V mutation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This open-label, multicenter Phase 1/1b trial enrolls adults with advanced KRAS G12V-mutant solid tumors to characterize safety, tolerability, pharmacokinetics, and preliminary antitumor activity of RMC-5127 as monotherapy and in two combination regimens. Participants are assigned to one of three arms—RMC-5127 alone, RMC-5127 plus daraxonrasib, or RMC-5127 plus cetuximab—with each arm including a dose exploration (Part 1) followed by a dose-expansion cohort (Part 2). Dose escalation will identify recommended doses and may include food-effect cohorts for the monotherapy arm, and efficacy signals will be monitored using RECIST v1.1 tumor measurements. The study collects safety labs, pharmacokinetic samples, and tumor response data across multiple U.S. sites.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* At least 18 years old and has provided informed consent.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
* Pathologically documented, locally advanced or metastatic KRAS G12V-mutated solid tumor malignancy.
* Received and progressed or been intolerant to prior standard therapy (including targeted therapy) appropriate for tumor type and stage.
* Measurable per RECIST v1.1
* Adequate organ function (bone marrow, liver, kidney, coagulation).
* Able to take oral medications.

Exclusion Criteria:

* Primary central nervous system (CNS) tumors
* Prior therapy with KRAS G12V inhibitor or direct RAS-targeted therapy (eg. degraders and/or inhibitors).
* Any conditions that may affect the ability to take or absorb study drug.
* Major surgery within 28 days prior to receiving study drug(s).
* Patient is unable or unwilling to comply with protocol-required study visits or procedures.

Where it's running

• Yale Cancer Center
  New Haven, Connecticut, United States Recruiting
• Johns Hopkins
  Baltimore, Maryland, United States Recruiting
• Dana-Farber Cancer Institute
  Boston, Massachusetts, United States Recruiting
• START Midwest
  Grand Rapids, Michigan, United States Recruiting
• Laura and Isaac Perlmutter Cancer Center at NYU Langone Health
  New York, New York, United States Recruiting
• NEXT - Dallas
  Dallas, Texas, United States Recruiting

Study contacts

• Study coordinator: Revolution Medicines Study Director
• Email: medinfo@revmed.com
• Phone: 1-844-2-REVMED

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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.