Study of RMC-9805 in Participants With KRAS G12D-Mutant Solid Tumors

Last updated: April 1, 2025
Sponsor: Revolution Medicines, Inc.
Overall Status: Active - Recruiting

Phase

1

Condition

Adenocarcinoma

Treatment

RMC-6236

RMC-9805

Clinical Study ID

NCT06040541
RMC-9805-001
  • Ages > 18
  • All Genders

Study Summary

This study is to evaluate the safety and tolerability of RMC-9805 as monotherapy and in combination with RMC-6236 in adults with KRAS G12D-mutant solid tumors.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Pathologically documented, locally advanced or metastatic solid tumor with a KRASG12D-mutation

  • Received and progressed or been intolerant to prior standard therapy (includingtargeted therapy) appropriate for tumor type and stage

  • ECOG performance status 0 or 1

  • Adequate organ function

Exclusion

Exclusion Criteria:

  • Primary central nervous system (CNS) tumors

  • Known or suspected leptomeningeal or active brain metastases or spinal cordcompression

  • Known or suspected impairment of gastrointestinal function that may prohibit abilityto swallow or absorb an oral medication

  • Participant was previously treated with an investigational KRAS G12D inhibitor, pan-or multi-RAS inhibitor, or had prior therapy with any direct RAS-targeted therapy (eg, degraders and inhibitors)

Other inclusion/exclusion criteria may apply.

Study Design

Total Participants: 444
Treatment Group(s): 2
Primary Treatment: RMC-6236
Phase: 1
Study Start date:
September 07, 2023
Estimated Completion Date:
April 30, 2027

Study Description

This is an open-label, multicenter, Phase 1/1b study of RMC-9805, a selective and orally bioavailable KRAS G12D(ON) inhibitor, in subjects with KRASG12D-mutant solid tumors to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary clinical activity. The study consists of two arms: RMC-9805 monotherapy arm and RMC-9805 plus RMC-6236 combination arm. Both arms consist of two parts: Part 1- dose exploration and Part 2- dose expansion.

Connect with a study center

  • University of California, Davis Comprehensive Cancer Center

    Sacramento, California 95817
    United States

    Active - Recruiting

  • Smilow Cancer Hospital (Yale University)

    New Haven, Connecticut 06511
    United States

    Active - Recruiting

  • Florida Cancer Specialists

    Sarasota, Florida 34232
    United States

    Active - Recruiting

  • Lee Moffitt Cancer Center

    Tampa, Florida 33612
    United States

    Active - Recruiting

  • Johns Hopkins University

    Baltimore, Maryland 21287
    United States

    Active - Recruiting

  • Dana-Farber Cancer Institute

    Boston, Massachusetts 02215
    United States

    Active - Recruiting

  • Massachusetts General Hospital

    Boston, Massachusetts 02114
    United States

    Active - Recruiting

  • Memorial Sloan Kettering Cancer Center

    New York, New York 10065
    United States

    Active - Recruiting

  • NYU Langone

    New York, New York 10016
    United States

    Active - Recruiting

  • Duke Cancer Center

    Durham, North Carolina 27710
    United States

    Active - Recruiting

  • Carolina BioOncology Institute

    Huntersville, North Carolina 28078
    United States

    Active - Recruiting

  • The Christ Hospital

    Cincinnati, Ohio 45219
    United States

    Active - Recruiting

  • Sarah Cannon Research Institute

    Nashville, Tennessee 37203
    United States

    Active - Recruiting

  • Mary Crowley Cancer Research

    Dallas, Texas 75230
    United States

    Active - Recruiting

  • University of Texas, MD Anderson Cancer Center

    Houston, Texas 77030
    United States

    Active - Recruiting

  • START

    San Antonio, Texas 78229
    United States

    Active - Recruiting

  • NEXT Oncology Virginia

    Fairfax, Virginia 22031
    United States

    Active - Recruiting

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