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

Last updated: November 12, 2024
Sponsor: Revolution Medicines, Inc.
Overall Status: Active - Recruiting

Phase

1

Condition

Adenocarcinoma

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).

  • Received prior standard therapy appropriate for tumor type and 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: 614
Treatment Group(s): 1
Primary Treatment: RMC-6236
Phase: 1
Study Start date:
May 31, 2022
Estimated Completion Date:
June 30, 2026

Study Description

This is a Phase 1/1b, 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

    Active - Recruiting

  • UCLA

    Santa Monica, California 90404
    United States

    Active - Recruiting

  • 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

  • Columbia University

    New York, New York 10032
    United States

    Active - Recruiting

  • 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

  • Christ Hospital Cancer Center

    Cincinnati, Ohio 45219
    United States

    Active - Recruiting

  • Sarah Cannon Research Institute

    Nashville, Tennessee 37203
    United States

    Active - Recruiting

  • University of Texas at Austin

    Austin, Texas 78712
    United States

    Active - Recruiting

  • Mary Crowley Cancer Research

    Dallas, Texas 75230
    United States

    Active - Recruiting

  • The University of Texas MD Anderson Cancer Center

    Houston, Texas 77030
    United States

    Active - Recruiting

  • Next Oncology

    San Antonio, Texas 78229
    United States

    Active - Recruiting

  • Huntsman Cancer Institute

    Salt Lake City, Utah 84112
    United States

    Active - Recruiting

  • Next Oncology Virginia

    Fairfax, Virginia 22031
    United States

    Active - Recruiting

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