RecruitingPhase 1NCT07349537

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

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

Sponsor

Revolution Medicines, Inc.

Enrollment

574 participants

Start Date

Jan 8, 2026

Study Type

INTERVENTIONAL

Conditions

Pancreatic Cancer Non-small Cell Lung Cancer (NSCLC)Pancreatic Ductal Adenocarcinoma (PDAC)Advanced Solid Tumors NSCLC Pancreatic Adenocarcinoma CRC Lung Cancer (NSCLC)Colorectal Cancer (CRC)PDAC

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria7

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 Criteria5

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.