Active Not RecruitingPhase 1NCT05462717

Dose Escalation and Dose Expansion Study of RMC-6291 Monotherapy in Subjects With Advanced KRASG12C Mutant Solid Tumors

The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (PK) of escalating doses of RMC-6291 (KRAS G12C(ON) inhibitor) monotherapy in adult subjects with advanced solid tumors and to identify the maximum tolerated dose (MTD), and the recommended Phase 2 dose.

Checked against the public recordLast updated May 15, 2026 · Source: ClinicalTrials.gov

StatusActive Not Recruiting
PhasePhase 1
U.S. locations64
SponsorRevolution Medicines, Inc.
01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 1
Sponsor
Revolution Medicines, Inc.
Interventions being studied
Drug: RMC-6291
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

Inclusion Criteria: * Subject must be ≥18 years of age. * Subject must have pathologically documented, locally advanced or metastatic KRASG12C-mutated solid tumor malignancy (not amenable to curative surgery) that has previously been treated with standard-of-care therapies for respective tumor types, is intolerant to, or is considered ineligible for standard-of-care anticancer treatments. * ECOG performance status 0 or 1 * Prior treatment with a KRASG12C (OFF) inhibitor allowed for dose escalation and for NSCLC in dose expansion * Adequate organ function Exclusion Criteria: * Primary central nervous system (CNS) tumors * Active brain metastases * Known impairment of GI function that would alter the absorption * Major surgical procedures within 28 days or non-study-related minor procedures within 7 days of treatment. * Prior therapy with KRASG12C (ON) inhibitor Other inclusion/exclusion criteria may apply.

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Highlands Oncology GroupSpringdale, Arkansas
  • UC Irvine Cancer CenterOrange, California
  • UC Davis Cancer CenterSacramento, California
  • UCSFSan Francisco, California
  • University of Miami School of Medicine Sylvester Comprehensive Cancer CenterMiami, Florida
  • Moffitt Cancer CenterTampa, Florida
  • American Oncology Partners of MarylandBethesda, Maryland
  • Dana-Farber Cancer InstituteBoston, Massachusetts
  • Roswell Park Comprehensive Cancer CenterBuffalo, New York
  • MSK Cancer CenterNew York, New York
  • Columbia University Irving Medical CenterNew York, New York
  • Tennessee OncologyNashville, Tennessee

Source and freshness
Processed from ClinicalTrials.gov. Last public update: May 15, 2026. Always confirm current availability with the study team.

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