Dose Escalation and Dose Expansion Study of RMC-6291 Monotherapy in Subjects With Advanced KRASG12C Mutant Solid Tumors

Last updated: April 6, 2026
Sponsor: Revolution Medicines, Inc.
Overall Status: Active - Not Recruiting

Phase

1

Condition

Digestive System Neoplasms

Gastric Cancer

Rectal Cancer

Treatment

RMC-6291

Clinical Study ID

NCT05462717
RMC-6291-001
  • Ages > 18
  • All Genders

Study Summary

The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (PK) of escalating doses of RMC-6291 (KRAS G12C(ON) inhibitor) monotherapy in adult subjects with advanced solid tumors and to identify the maximum tolerated dose (MTD), and the recommended Phase 2 dose.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Subject must be ≥18 years of age.

  • Subject must have pathologically documented, locally advanced or metastaticKRASG12C-mutated solid tumor malignancy (not amenable to curative surgery) that haspreviously been treated with standard-of-care therapies for respective tumor types,is intolerant to, or is considered ineligible for standard-of-care anticancertreatments.

  • ECOG performance status 0 or 1

  • Prior treatment with a KRASG12C (OFF) inhibitor allowed for dose escalation and forNSCLC in dose expansion

  • 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.

  • Prior therapy with KRASG12C (ON) inhibitor

Other inclusion/exclusion criteria may apply.

Study Design

Total Participants: 222
Treatment Group(s): 1
Primary Treatment: RMC-6291
Phase: 1
Study Start date:
September 19, 2022
Estimated Completion Date:
September 30, 2027

Study Description

This is an open-label, multicenter, Phase 1/1b study of RMC-6291 monotherapy in subjects with advanced KRASG12C-mutant solid tumors. The study will include 2 components: a Dose-Escalation and a Dose-Expansion. Subjects will be treated until disease progression per RECIST v1.1, unacceptable toxicity, or other criteria for withdrawal are met, whichever occurs first.

Connect with a study center

  • Southside Cancer Care Centre

    Sydney, New South Wales 2228
    Australia

    Site Not Available

  • Peninsula & South Eastern Haematology and Oncology Group

    Frankston, Victoria 3199
    Australia

    Site Not Available

  • Austin Health, Olivia Newton-John Cancer Research & Wellness Centre

    Heidelberg, Victoria 3084
    Australia

    Site Not Available

  • South West Health Care

    Warrnambool, Victoria 3280
    Australia

    Site Not Available

  • NH Hospital a.s.

    Hořovice, 268 31
    Czechia

    Site Not Available

  • Klinika onkologie a radioterapie, Fakultni Nemocnice Hradec Kralove

    Hradec Králové, 50005
    Czechia

    Site Not Available

  • Onkologicka klinika, Fakultni Nemocnice Olomouc

    Olomouc, 77900
    Czechia

    Site Not Available

  • ICO

    Angers, 49055
    France

    Site Not Available

  • CHU Bordeaux Hospital Saint-Andre

    Bordeaux, 33000
    France

    Site Not Available

  • Centre Jean Perrin

    Clermont-Ferrand, 63011
    France

    Site Not Available

  • Centre Oscar Lambret

    Lille, 59000
    France

    Site Not Available

  • Centre Léon Bérard

    Lyon, 69008
    France

    Site Not Available

  • CHU Nantes

    Nantes, 44093
    France

    Site Not Available

  • ICANS

    Strasbourg, 67200
    France

    Site Not Available

  • Istituto Europeo Oncologico

    Milan, 20141
    Italy

    Site Not Available

  • S.C. Oncologia Falck, Dipartimento Ematologia ed Oncologia Niguarda Cancer Center

    Milan, 20162
    Italy

    Site Not Available

  • Istituto Europeo Oncologico

    Milano, 20141
    Italy

    Site Not Available

  • Istituto Nazionale Tumori Fondazione G. Pascale

    Naples, 80131
    Italy

    Site Not Available

  • Istituto Nazionale Tumori Fondazione G. Pascale

    Napoli, 80131
    Italy

    Site Not Available

  • Azienda Ospedaliero-Universitaria San Luigi Gonzaga

    Orbassano, 10043
    Italy

    Site Not Available

  • Fondazione IRCCS Policlinico San Matteo

    Pavia, 27100
    Italy

    Site Not Available

  • Centro Ricerche Cliniche di Verona s.r.l.

    Verona, 37134
    Italy

    Site Not Available

  • Ajou University Hospital

    Suwon-si, Gyeonggi-do 16499
    Korea, Republic of

    Site Not Available

  • Korea University Hospital

    Seoul, 02708
    Korea, Republic of

    Site Not Available

  • Seoul National University Hospital

    Seoul, 3080
    Korea, Republic of

    Site Not Available

  • Severance Hospital

    Seoul, 3722
    Korea, Republic of

    Site Not Available

  • University Malaya Medical Centre

    Kuala Lumpur, 59100
    Malaysia

    Site Not Available

  • Sarawak General Hospital

    Kuching, 93586
    Malaysia

    Site Not Available

  • Instytut MSF Sp zoo

    Lodz, 90-302
    Poland

    Site Not Available

  • Med - Polonia Sp. z o. o.

    Poznan, 60-693
    Poland

    Site Not Available

  • Med - Polonia Sp. z o. o.

    Poznań, 60-693
    Poland

    Site Not Available

  • Narodowy Instytut Onkologii

    Warsaw, 02-781
    Poland

    Site Not Available

  • Instytut MSF Sp zoo

    Łódź, 90-302
    Poland

    Site Not Available

  • Clinical hospital center Bezanijska Kosa

    Belgrade, 11071
    Serbia

    Site Not Available

  • MSB General Hospital

    Belgrade, 11000
    Serbia

    Site Not Available

  • Institute for pulmonary diseases Sremska Kamenica

    Kamenitz, 21204
    Serbia

    Site Not Available

  • Institute for pulmonary diseases Sremska Kamenica

    Sremska Kamenica, 21204
    Serbia

    Site Not Available

  • National Cancer centre Singapore

    Singapore, 168583
    Singapore

    Site Not Available

  • Ajou University Hospital

    Suwon, Gyeonggi-do 16499
    South Korea

    Site Not Available

  • Korea University Hospital

    Seoul, 02708
    South Korea

    Site Not Available

  • Seoul National University Hospital

    Seoul, 3080
    South Korea

    Site Not Available

  • Severance Hospital

    Seoul, 3722
    South Korea

    Site Not Available

  • ICO Hospitalet

    Barcelona, 08908
    Spain

    Site Not Available

  • NEXT Oncology IOB Hospital Quirónsalud

    Barcelona, 08023
    Spain

    Site Not Available

  • Clínica Universidad de Navarra

    Madrid, 28027
    Spain

    Site Not Available

  • Hospital Universitario Fundación Jiménez Díaz

    Madrid, 28040
    Spain

    Site Not Available

  • MD Anderson Cancer Center

    Madrid, 28033
    Spain

    Site Not Available

  • Clinica Universidad de Navarra

    Pamplona, 31008
    Spain

    Site Not Available

  • Hospital Universitario Quirónsalud

    Pozuelo de Alarcón, 28223
    Spain

    Site Not Available

  • Hospital Universitario Virgen del Rocío

    Sevilla, 41013
    Spain

    Site Not Available

  • Hospital Universitario Virgen del Rocío

    Seville, 41013
    Spain

    Site Not Available

  • Hospital Universitario Miguel Servet

    Zaragoza, 50009
    Spain

    Site Not Available

  • E-DA hospital

    Kaohsiung, Yanchao District 82445
    Taiwan

    Site Not Available

  • E-DA hospital

    Kaohsiung City, Yanchao District 82445
    Taiwan

    Site Not Available

  • Taipei Tzu Chi Hospital

    New Taipei City, 231
    Taiwan

    Site Not Available

  • National Cheng Kung University Hospital

    Tainan, 70457
    Taiwan

    Site Not Available

  • National Taiwan University Hospital

    Taipei, 10048
    Taiwan

    Site Not Available

  • Siriraj Hospital

    Bangkok Noi, 10700
    Thailand

    Site Not Available

  • Chiang Mai University

    Chiang Mai, 50200
    Thailand

    Site Not Available

  • Khon Kaen University

    Khon Kaen, 40002
    Thailand

    Site Not Available

  • Highlands Oncology Group

    Springdale, Arkansas 72762
    United States

    Site Not Available

  • UC Irvine Cancer Center

    Orange, California 92868
    United States

    Site Not Available

  • UC Davis Cancer Center

    Sacramento, California 95817
    United States

    Site Not Available

  • UCSF

    San Francisco, California 94158
    United States

    Site Not Available

  • University of Miami School of Medicine Sylvester Comprehensive Cancer Center

    Miami, Florida 33136
    United States

    Site Not Available

  • Moffitt Cancer Center

    Tampa, Florida 33612
    United States

    Site Not Available

  • American Oncology Partners of Maryland

    Bethesda, Maryland 20817
    United States

    Site Not Available

  • Dana-Farber Cancer Institute

    Boston, Massachusetts 02215
    United States

    Site Not Available

  • Roswell Park Comprehensive Cancer Center

    Buffalo, New York 14203
    United States

    Site Not Available

  • Columbia University Irving Medical Center

    New York, New York 10032
    United States

    Site Not Available

  • MSK Cancer Center

    New York, New York 10021
    United States

    Site Not Available

  • Tennessee Oncology

    Nashville, Tennessee 37203
    United States

    Site Not Available

  • Next Oncology

    San Antonio, Texas 78229
    United States

    Site Not Available

  • START

    San Antonio, Texas 78229
    United States

    Site Not Available

  • Next Oncology Virginia

    Fairfax, Virginia 22031
    United States

    Site Not Available

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