Study of RMC-6291 in Combination with RMC-6236 in Participants with Advanced KRAS G12C Mutant Solid Tumors

Last updated: March 24, 2025
Sponsor: Revolution Medicines, Inc.
Overall Status: Active - Recruiting

Phase

1

Condition

Pancreatic Cancer

Colon Cancer; Rectal Cancer

Pancreatic Disorders

Treatment

Assigned interventions

Clinical Study ID

NCT06128551
RMC-6291-101
  • Ages 18-125
  • All Genders

Study Summary

This study is to evaluate the safety, tolerability, and PK profiles of RMC-6291 and RMC-6236 in adults with KRAS G12C-mutated solid tumors.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 18 years of age

  • Histology: pathologically documented, KRAS G12C-mutated, advanced or metastaticsolid tumors not amendable to curative therapy

  1. Part 1. Dose Escalation: solid tumors, previously treated

  2. Part 2. Dose Expansion: i. NSCLC, previously treated with immunotherapy, chemotherapy, and KRAS G12C (OFF)inhibitors, ii. NSCLC, previously treated with immunotherapy and chemotherapy, naïveto KRAS G12C (OFF) inhibitors, iii. NSCLC, previously treated with immunotherapy,chemotherapy, with untreated, asymptomatic central nervous system (CNS) metastases <2 cm in size iv. Solid tumors, previously treated, naïve to KRAS G12C (OFF)inhibitors.

  • ECOG performance status 0 or 1

  • Adequate organ function

Exclusion

Exclusion Criteria:

  • Primary central nervous system (CNS) tumors

  • Active brain metastases

  • Known impairment of GI function that would alter the absorption

  • Major surgical procedures within 28 days or non-study related minor procedureswithin 7 days of treatment

Study Design

Total Participants: 210
Treatment Group(s): 1
Primary Treatment: Assigned interventions
Phase: 1
Study Start date:
November 14, 2023
Estimated Completion Date:
November 30, 2026

Study Description

This is an open-label, multicenter, Phase 1b study of RMC-6291 in combination with RMC-6236 in participants with advanced KRAS G12C-mutated solid tumors, to identify the maximum tolerated dose (MTD) and/or recommended Phase 2 dose and schedule (RP2DS) and provide a preliminary assessment of the antitumor activity of RMC-6291 in participants with KRASG12C tumors.

The study consists of two parts: Part 1 - Dose-Escalation and Part 2 Dose-Expansion.

Connect with a study center

  • West Cancer Institute

    Angers, 49055
    France

    Active - Recruiting

  • Institut Bergonie

    Bordeaux, 33000
    France

    Active - Recruiting

  • Hospital Louise Pradel

    Bron, 69500
    France

    Active - Recruiting

  • Oscar Lambret Center of Lillle

    Lille, 59000
    France

    Active - Recruiting

  • Centre Leon Berard

    Lyon, 69373
    France

    Active - Recruiting

  • Cancer Institute of Montpellier

    Montpellier, 34298
    France

    Active - Recruiting

  • CHU Nantes

    Nantes, 44093
    France

    Active - Recruiting

  • Institute of Cancer of Strasbourg

    Strasbourg, 67033
    France

    Active - Recruiting

  • Klinikum Esslingen GmbH

    Esslingen, 73730
    Germany

    Active - Recruiting

  • Universitäts Klinikum Köln

    Köln, 80937
    Germany

    Active - Recruiting

  • Krankenhaus Bethanien Moers

    Moers, 47441
    Germany

    Active - Recruiting

  • Klinkum Nurnberg Paracelsus Medical Unviersity

    Nurnberg, 90419
    Germany

    Active - Recruiting

  • Department of Medical Oncology - Azienda Ospedaliero Uniersitaria delle Marche

    Ancona, 60126
    Italy

    Active - Recruiting

  • Centro Di Riferimento Oncologico

    Aviano, 33081
    Italy

    Active - Recruiting

  • Institute Romagnolo per lo Studio Tumori

    Meldola, 47014
    Italy

    Active - Recruiting

  • Niguarda Cancer Center

    Milano, 20162
    Italy

    Active - Recruiting

  • S.C. Oncologic Falck

    Milano, 20162
    Italy

    Site Not Available

  • Istituto Nazionale Tumori IRCCS Fondazione "G. Pascale"

    Napoli, 80131
    Italy

    Active - Recruiting

  • San Luigi Hospital

    Orbassano, 10043
    Italy

    Active - Recruiting

  • AUSL Romagna - S.M. delle Croci Hospital

    Ravenna, 48121
    Italy

    Active - Recruiting

  • Netherlands Cancer Institute Antoni van Leeuwenhoek

    Amsterdam, 1066CX
    Netherlands

    Active - Recruiting

  • Pan American Center for Oncology Trials

    San Juan, 00935
    Puerto Rico

    Active - Recruiting

  • Institut Catala d'Oncologia Hospital

    Barcelona, 08908
    Spain

    Active - Recruiting

  • START Barcelona - Hospital HM Nou Delfos

    Barcelona, 08023
    Spain

    Active - Recruiting

  • Fundacion MD Anderson Cancer Center

    Madrid, 28033
    Spain

    Active - Recruiting

  • Hosptial Universitario 12 de Octubre

    Madrid, 28041
    Spain

    Active - Recruiting

  • NEXT Oncology - Quirónsalud Madrid University Hospital

    Madrid, 28223
    Spain

    Active - Recruiting

  • START Madrid

    Madrid, 28040
    Spain

    Active - Recruiting

  • University Clinic of Navarra

    Madrid, 28027
    Spain

    Active - Recruiting

  • University Clinic of Navarra

    Pamplona, 31008
    Spain

    Active - Recruiting

  • Hosptial Universitario Virgen Macarena

    Sevilla, 41009
    Spain

    Active - Recruiting

  • La Fe University and Polytechnic Hospital

    Valencia, 46026
    Spain

    Active - Recruiting

  • Hospital Universitario Miguel Servet

    Zaragoza, 50009
    Spain

    Active - Recruiting

  • City of Hope

    Duarte, California 91010
    United States

    Active - Recruiting

  • UC IRVINE Health

    Orange, California 92868
    United States

    Active - Recruiting

  • UC Davis Comprehensive Cancer Center

    Sacramento, California 95817
    United States

    Active - Recruiting

  • Stanford Cancer Institute

    Stanford, California 94305
    United States

    Active - Recruiting

  • University of Colorado Cancer Center

    Aurora, Colorado 80045
    United States

    Active - Recruiting

  • Florida Cancer Specialists

    Sarasota, Florida 34232
    United States

    Active - Recruiting

  • Moffitt Cancer Center and Research Institute

    Tampa, Florida 33612
    United States

    Active - Recruiting

  • Dana Farber Cancer Institute

    Boston, Massachusetts 02215
    United States

    Active - Recruiting

  • Henry Ford Cancer

    Detroit, Michigan 48202
    United States

    Active - Recruiting

  • START Midwest

    Grand Rapids, Michigan 49546
    United States

    Active - Recruiting

  • Columbia University

    New York, New York 10032
    United States

    Active - Recruiting

  • Memorial Sloan Kettering Cancer Center

    New York, New York 10065
    United States

    Active - Recruiting

  • NYU Langone Health

    New York, New York 10032
    United States

    Active - Recruiting

  • University of Oklahoma

    Oklahoma City, Oklahoma 73104
    United States

    Active - Recruiting

  • Sarah Cannon Research Institue

    Nashville, Tennessee 37203
    United States

    Active - Recruiting

  • Mary Crowley Cancer Research

    Dallas, Texas 75230
    United States

    Active - Recruiting

  • MD Anderson

    Houston, Texas 77030
    United States

    Active - Recruiting

  • NEXT Dallas

    Irving, Texas 75039
    United States

    Active - Recruiting

  • NEXT Oncology San Antonio

    San Antonio, Texas 78229
    United States

    Active - Recruiting

  • START Texas

    San Antonio, Texas 78229
    United States

    Active - Recruiting

  • NEXT Oncology Virginia

    Fairfax, Virginia 22031
    United States

    Active - Recruiting

  • Medical College of Wisconsin

    Milwaukee, Wisconsin 53226
    United States

    Site Not Available

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