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RecruitingPhase 1NCT07349537
Official study title

Study of RMC-5127 in Patients With Advanced KRAS G12V-Mutant Solid Tumors

Study summary

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary antitumor activity of RMC-5127 as a monotherapy and in combination with either daraxonrasib or cetuximab in adults with KRAS G12V-mutant solid tumors.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedRMC-5127 and daraxonrasib

Plus 1 other study approaches.

Who it may be forNon-small cell lung cancer (NSCLC) · KRAS

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Sep 17, 2026 · Source: ClinicalTrials.gov

Is enrollment open?Recruiting

The study is currently accepting participants.

What kind of study?Phase 1

Interventional

Where is it offered?9 U.S. locations

Locations may change over time.

Who runs it?Revolution Medicines, Inc.

Study sponsor

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-5127; Drug: daraxonrasib; Drug: cetuximab
02
Explore related studies

How this study is categorized

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

Cancer type
Non-small cell lung cancer (NSCLC)→
Biomarkers
KRAS→
03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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.
Reasons someone may not be able to joinExclusion 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.

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

  • Yale Cancer CenterNew Haven, Connecticut
  • Johns HopkinsBaltimore, Maryland
  • Dana-Farber Cancer InstituteBoston, Massachusetts
  • START MidwestGrand Rapids, Michigan
  • Laura and Isaac Perlmutter Cancer Center at NYU Langone HealthNew York, New York
  • NEXT - DallasDallas, Texas
  • NEXTSan Antonio, Texas
  • START - San AntonioSan Antonio, Texas
  • NEXT - VirginiaFairfax, Virginia

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Sep 17, 2026. Always confirm current availability with the study team.

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