Study of RMC-6236 in Patients With Advanced Solid Tumors Harboring Specific Mutations in RAS

Last updated: November 7, 2025
Sponsor: Revolution Medicines, Inc.
Overall Status: Active - Recruiting

Phase

1/2

Condition

Colorectal Cancer

Colon Cancer

Digestive System Neoplasms

Treatment

RMC-6236

Clinical Study ID

NCT05379985
RMC-6236-001
  • Ages > 18
  • All Genders

Study Summary

Evaluate the safety and tolerability of RMC-6236 in adults with specific RAS mutant advanced solid tumors.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Histologically confirmed advanced solid tumor with specific KRAS G12 mutations (doseescalation) or RAS mutations (dose optimization/expansion) identified throughdeoxyribonucleic acid (DNA) sequencing. PDAC with wild-type RAS (expansion).

  • Treatment naive or have received prior standard therapy appropriate for tumor typeand stage

  • Have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

  • Adequate organ function

Exclusion

Exclusion Criteria:

  • Primary central nervous system (CNS) tumors

  • Active, untreated brain metastases

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

  • History of any other unstable or clinically significant concurrent medical conditionthat would, in the opinion of the investigator, jeopardize the safety of aparticipant, impact their expected survival through the end of the studyparticipation, and/or impact their ability to comply with the protocolprior/concomitant therapy

Other inclusion/exclusion criteria may apply.

Study Design

Total Participants: 754
Treatment Group(s): 1
Primary Treatment: RMC-6236
Phase: 1/2
Study Start date:
May 31, 2022
Estimated Completion Date:
July 26, 2027

Study Description

This is a Phase 1/2, multicenter open-label study to evaluate the safety, tolerability, pharmacokinetics (PK), and clinical activity of escalating doses of RMC-6236 in adult patients with advanced solid tumors harboring specific RAS mutations, and to determine the maximum tolerated dose (MTD) and/or recommended phase 2 dose [RP2D] within investigated patient population groups. RMC-6236 is a potent, orally bioavailable RAS-MULTI(ON) inhibitor, selective for the active RAS(ON) form of both wild type and mutant variants of the canonical RAS isoforms (HRAS, NRAS, and KRAS).

Connect with a study center

  • UC Irvine/Chao Family Comprehensive Cancer Center

    Orange, California 92868
    United States

    Site Not Available

  • UCLA

    Santa Monica, California 90404
    United States

    Site Not Available

  • UC Irvine/Chao Family Comprehensive Cancer Center

    Orange 5379513, California 5332921 92868
    United States

    Active - Recruiting

  • UCLA

    Santa Monica 5393212, California 5332921 90404
    United States

    Active - Recruiting

  • Moffitt Cancer Center

    Tampa, Florida 33612
    United States

    Site Not Available

  • Moffitt Cancer Center

    Tampa 4174757, Florida 4155751 33612
    United States

    Active - Recruiting

  • Johns Hopkins University

    Baltimore, Maryland 21287
    United States

    Site Not Available

  • Johns Hopkins University

    Baltimore 4347778, Maryland 4361885 21287
    United States

    Active - Recruiting

  • Dana Farber Cancer Institute

    Boston, Massachusetts 02215
    United States

    Site Not Available

  • Dana Farber Cancer Institute

    Boston 4930956, Massachusetts 6254926 02215
    United States

    Active - Recruiting

  • Columbia University

    New York, New York 10032
    United States

    Site Not Available

  • Memorial Sloan-Kettering Cancer Center

    New York, New York 10021
    United States

    Active - Recruiting

  • Perlmutter Cancer Center at NYU Langone Health

    New York, New York 10016
    United States

    Active - Recruiting

  • Columbia University

    New York 5128581, New York 5128638 10032
    United States

    Active - Recruiting

  • Memorial Sloan-Kettering Cancer Center

    New York 5128581, New York 5128638 10021
    United States

    Active - Recruiting

  • Perlmutter Cancer Center at NYU Langone Health

    New York 5128581, New York 5128638 10016
    United States

    Active - Recruiting

  • Christ Hospital Cancer Center

    Cincinnati, Ohio 45219
    United States

    Site Not Available

  • Christ Hospital Cancer Center

    Cincinnati 4508722, Ohio 5165418 45219
    United States

    Active - Recruiting

  • Sarah Cannon Research Institute

    Nashville, Tennessee 37203
    United States

    Site Not Available

  • Sarah Cannon Research Institute

    Nashville 4644585, Tennessee 4662168 37203
    United States

    Active - Recruiting

  • University of Texas at Austin

    Austin, Texas 78712
    United States

    Site Not Available

  • Mary Crowley Cancer Research

    Dallas, Texas 75230
    United States

    Site Not Available

  • The University of Texas MD Anderson Cancer Center

    Houston, Texas 77030
    United States

    Site Not Available

  • Next Oncology

    San Antonio, Texas 78229
    United States

    Site Not Available

  • University of Texas at Austin

    Austin 4671654, Texas 4736286 78712
    United States

    Active - Recruiting

  • Mary Crowley Cancer Research

    Dallas 4684888, Texas 4736286 75230
    United States

    Active - Recruiting

  • The University of Texas MD Anderson Cancer Center

    Houston 4699066, Texas 4736286 77030
    United States

    Active - Recruiting

  • Next Oncology

    San Antonio 4726206, Texas 4736286 78229
    United States

    Active - Recruiting

  • Huntsman Cancer Institute

    Salt Lake City, Utah 84112
    United States

    Site Not Available

  • Huntsman Cancer Institute

    Salt Lake City 5780993, Utah 5549030 84112
    United States

    Active - Recruiting

  • Next Oncology Virginia

    Fairfax, Virginia 22031
    United States

    Site Not Available

  • Next Oncology Virginia

    Fairfax 4758023, Virginia 6254928 22031
    United States

    Active - Recruiting

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