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

RecruitingPhase 1

Phase 1/1b, Multicenter, Open-Label, Study of RMC-5127 in Patients With Advanced KRAS G12V-Mutant Solid Tumors

Who can join

Ages 18 and older · All sexes

Full eligibility criteria
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.

About the study

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.

What is being tested

Sponsor: Revolution Medicines, Inc. · Participants: 574 · Started: Jan 8, 2026

Contact the study team

Official record on ClinicalTrials.gov — NCT07349537

Locations in the U.S.

ConnecticutYale Cancer Center, New Haven
MarylandJohns Hopkins, Baltimore
MassachusettsDana-Farber Cancer Institute, Boston
MichiganSTART Midwest, Grand Rapids
New YorkLaura and Isaac Perlmutter Cancer Center at NYU Langone Health, New York
TexasNEXT - Dallas, Dallas
NEXT, San Antonio
START - San Antonio, San Antonio
VirginiaNEXT - Virginia, Fairfax

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.