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

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

Plain Language Summary

Simplified for easier understanding

This study is testing a new targeted drug called RMC-5127 for people with advanced cancers that have a specific mutation called KRAS G12V. KRAS mutations are found in many difficult-to-treat cancers, and this drug is designed to directly block the mutated KRAS protein. **You may be eligible if...** - You are 18 or older - Your cancer has a confirmed KRAS G12V mutation and has spread or cannot be surgically removed - Your cancer progressed on or you could not tolerate previous standard treatments - You are in good physical condition (ECOG 0 or 1) - You can swallow tablets and have adequate organ function **You may NOT be eligible if...** - Your cancer started in the brain (primary CNS tumor) - You have previously received a KRAS G12V inhibitor or direct RAS-targeting therapy - You had major surgery in the past 28 days - You cannot comply with study visits or procedures Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGRMC-5127

oral tablets

DRUGdaraxonrasib

oral tablets

DRUGcetuximab

IV infusion


Locations(5)

START Midwest

Grand Rapids, Michigan, United States

NEXT - Dallas

Dallas, Texas, United States

NEXT

San Antonio, Texas, United States

START - San Antonio

San Antonio, Texas, United States

NEXT - Virginia

Fairfax, Virginia, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT07349537


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