Actively Recruiting

Phase 1
Age: 18Years +
All Genders
NCT07349537

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

Led by Revolution Medicines, Inc. · Updated on 2026-02-04

574

Participants Needed

5

Research Sites

142 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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 appropriate for tumor type and stage.
  • Measurable disease per RECIST v1.1 criteria.
  • Adequate organ function including bone marrow, liver, kidney, and coagulation.
  • Able to take oral medications.
Not Eligible

You will not qualify if you...

  • Primary central nervous system (CNS) tumors.
  • Prior therapy with KRAS G12V inhibitor or direct RAS-targeted therapy such as degraders or inhibitors.
  • Any condition affecting the ability to take or absorb the study drug.
  • Major surgery within 28 days prior to receiving study drug(s).
  • Inability or unwillingness to comply with study visits or procedures.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 5 locations

1

START Midwest

Grand Rapids, Michigan, United States, 49546

Actively Recruiting

2

NEXT - Dallas

Dallas, Texas, United States, 75039

Actively Recruiting

3

NEXT

San Antonio, Texas, United States, 78229

Actively Recruiting

4

START - San Antonio

San Antonio, Texas, United States, 78229

Actively Recruiting

5

NEXT - Virginia

Fairfax, Virginia, United States, 22031

Actively Recruiting

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Research Team

R

Revolution Medicines Study Director

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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