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

Recruiting now · Phase 1

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

In brief

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.

Key facts

Study ID

NCT07349537

Run by

Revolution Medicines, Inc.

People needed

574

Starts

2026-01-08

Expected to finish

2028-10-01

Last updated by the study team

2026-07-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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 is running

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

Full record on ClinicalTrials.gov

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