Study of Elironrasib and Daraxonrasib as Monotherapies and Combination Therapy in Participants With Advanced KRAS G12C Mutant Solid Tumors

Last updated: February 6, 2026
Sponsor: Revolution Medicines, Inc.
Overall Status: Active - Recruiting

Phase

1/2

Condition

Endometrial Cancer

Gastrointestinal Diseases And Disorders

Esophageal Disorders

Treatment

Assigned interventions

Daraxonrasib

Elironrasib

Clinical Study ID

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

Study Summary

This study is to evaluate the safety, tolerability, and PK profiles of Elironrasib and Daraxonrasib as monotherapies and combination therapy in patients 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. Phase 1b Dose Escalation: solid tumors, previously treated

  2. Phase 1b Dose Expansion and Phase 2: i. NSCLC, previously treated with immunotherapy, chemotherapy, and KRAS G12C (OFF)inhibitors ii. 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: 534
Treatment Group(s): 3
Primary Treatment: Assigned interventions
Phase: 1/2
Study Start date:
November 14, 2023
Estimated Completion Date:
June 30, 2029

Study Description

This is an open-label, multicenter, Phase 1b/2 study evaluating elironrasib and daraxonrasib, administered as monotherapy and in combination, in patients with advanced KRAS G12C-mutated solid tumors to determine the maximum tolerated dose (MTD), identify the recommended Phase 2 dose and schedule (RP2DS), and preliminarily assess antitumor activity.

The study includes a Phase 1b dose escalation and expansion of combination therapy, followed by a Phase 2 evaluation of the selected RP2DS as monotherapy and combination therapy to further assess safety and antitumor activity.

Connect with a study center

  • West Cancer Institute

    Angers, 49055
    France

    Site Not Available

  • West Cancer Institute

    Angers 3037656, 49055
    France

    Active - Recruiting

  • Institut Bergonie

    Bordeaux, 33000
    France

    Site Not Available

  • Institut Bergonie

    Bordeaux 3031582, 33000
    France

    Active - Recruiting

  • Hospital Louise Pradel

    Bron, 69500
    France

    Site Not Available

  • Hospital Louise Pradel

    Bron 3029931, 69500
    France

    Active - Recruiting

  • Oscar Lambret Center of Lillle

    Lille, 59000
    France

    Site Not Available

  • Oscar Lambret Center of Lillle

    Lille 2998324, 59000
    France

    Active - Recruiting

  • Centre Leon Berard

    Lyon, 69373
    France

    Site Not Available

  • Centre Leon Berard

    Lyon 2996944, 69373
    France

    Active - Recruiting

  • Cancer Institute of Montpellier

    Montpellier, 34298
    France

    Site Not Available

  • Cancer Institute of Montpellier

    Montpellier 2992166, 34298
    France

    Active - Recruiting

  • CHU Nantes

    Nantes, 44093
    France

    Site Not Available

  • CHU Nantes

    Nantes 2990969, 44093
    France

    Active - Recruiting

  • Institute of Cancer of Strasbourg

    Strasbourg, 67033
    France

    Site Not Available

  • Institute of Cancer of Strasbourg

    Strasbourg 2973783, 67033
    France

    Site Not Available

  • Universitäts Klinikum Köln

    Cologne 2886242, 80937
    Germany

    Active - Recruiting

  • Klinikum Esslingen GmbH

    Esslingen, 73730
    Germany

    Site Not Available

  • Klinikum Esslingen GmbH

    Esslingen am Neckar 2928751, 73730
    Germany

    Active - Recruiting

  • Universitäts Klinikum Köln

    Köln, 80937
    Germany

    Site Not Available

  • Krankenhaus Bethanien Moers

    Moers, 47441
    Germany

    Site Not Available

  • Krankenhaus Bethanien Moers

    Moers 2870221, 47441
    Germany

    Active - Recruiting

  • Klinkum Nurnberg Paracelsus Medical Unviersity

    Nuremberg 2861650, 90419
    Germany

    Active - Recruiting

  • Klinkum Nurnberg Paracelsus Medical Unviersity

    Nurnberg, 90419
    Germany

    Site Not Available

  • Department of Medical Oncology - Azienda Ospedaliero Uniersitaria delle Marche

    Ancona, 60126
    Italy

    Site Not Available

  • Department of Medical Oncology - Azienda Ospedaliero Uniersitaria delle Marche

    Ancona 3183089, 60126
    Italy

    Active - Recruiting

  • Centro Di Riferimento Oncologico

    Aviano, 33081
    Italy

    Site Not Available

  • Centro Di Riferimento Oncologico

    Aviano 3182635, 33081
    Italy

    Active - Recruiting

  • Institute Romagnolo per lo Studio Tumori

    Meldola, 47014
    Italy

    Site Not Available

  • Institute Romagnolo per lo Studio Tumori

    Meldola 3173635, 47014
    Italy

    Active - Recruiting

  • Niguarda Cancer Center

    Milan 6951411, 20162
    Italy

    Active - Recruiting

  • Niguarda Cancer Center

    Milano, 20162
    Italy

    Site Not Available

  • S.C. Oncologic Falck

    Milano, 20162
    Italy

    Site Not Available

  • Istituto Nazionale Tumori IRCCS Fondazione "G. Pascale"

    Napoli, 80131
    Italy

    Site Not Available

  • Istituto Nazionale Tumori IRCCS Fondazione "G. Pascale"

    Napoli 9031661, 80131
    Italy

    Active - Recruiting

  • San Luigi Hospital

    Orbassano, 10043
    Italy

    Site Not Available

  • San Luigi Hospital

    Orbassano 3171986, 10043
    Italy

    Active - Recruiting

  • AUSL Romagna - S.M. delle Croci Hospital

    Ravenna, 48121
    Italy

    Site Not Available

  • AUSL Romagna - S.M. delle Croci Hospital

    Ravenna 3169561, 48121
    Italy

    Active - Recruiting

  • Netherlands Cancer Institute Antoni van Leeuwenhoek

    Amsterdam, 1066CX
    Netherlands

    Site Not Available

  • Netherlands Cancer Institute Antoni van Leeuwenhoek

    Amsterdam 2759794, 1066CX
    Netherlands

    Active - Recruiting

  • Pan American Center for Oncology Trials

    San Juan, 00935
    Puerto Rico

    Site Not Available

  • Pan American Center for Oncology Trials

    San Juan 4568127, 00935
    Puerto Rico

    Active - Recruiting

  • Institut Catala d'Oncologia Hospital

    Barcelona, 08908
    Spain

    Site Not Available

  • START Barcelona - Hospital HM Nou Delfos

    Barcelona, 08023
    Spain

    Active - Recruiting

  • Institut Catala d'Oncologia Hospital

    Barcelona 3128760, 08908
    Spain

    Active - Recruiting

  • START Barcelona - Hospital HM Nou Delfos

    Barcelona 3128760, 08023
    Spain

    Active - Recruiting

  • Fundacion MD Anderson Cancer Center

    Madrid, 28033
    Spain

    Active - Recruiting

  • Hosptial Universitario 12 de Octubre

    Madrid, 28041
    Spain

    Site Not Available

  • 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

  • Fundacion MD Anderson Cancer Center

    Madrid 3117735, 28033
    Spain

    Active - Recruiting

  • Hospital Universitario 12 de Octubre

    Madrid 3117735, 28041
    Spain

    Active - Recruiting

  • NEXT Oncology - Quirónsalud Madrid University Hospital

    Madrid 3117735, 28223
    Spain

    Active - Recruiting

  • START Madrid

    Madrid 3117735, 28040
    Spain

    Active - Recruiting

  • University Clinic of Navarra

    Madrid 3117735, 28027
    Spain

    Active - Recruiting

  • University Clinic of Navarra

    Pamplona, 31008
    Spain

    Site Not Available

  • University Clinic of Navarra

    Pamplona 3114472, 31008
    Spain

    Active - Recruiting

  • Hosptial Universitario Virgen Macarena

    Sevilla, 41009
    Spain

    Site Not Available

  • Hospital Universitario Virgen Macarena

    Seville 2510911, 41009
    Spain

    Active - Recruiting

  • La Fe University and Polytechnic Hospital

    Valencia, 46026
    Spain

    Site Not Available

  • La Fe University and Polytechnic Hospital

    Valencia 2509954, 46026
    Spain

    Active - Recruiting

  • Hospital Universitario Miguel Servet

    Zaragoza, 50009
    Spain

    Site Not Available

  • Hospital Universitario Miguel Servet

    Zaragoza 3104324, 50009
    Spain

    Active - Recruiting

  • City of Hope

    Duarte, California 91010
    United States

    Site Not Available

  • UC IRVINE Health

    Orange, California 92868
    United States

    Site Not Available

  • UC Davis Comprehensive Cancer Center

    Sacramento, California 95817
    United States

    Site Not Available

  • Stanford Cancer Institute

    Stanford, California 94305
    United States

    Site Not Available

  • City of Hope

    Duarte 5344147, California 5332921 91010
    United States

    Site Not Available

  • UC IRVINE Health

    Orange 5379513, California 5332921 92868
    United States

    Active - Recruiting

  • UC Davis Comprehensive Cancer Center

    Sacramento 5389489, California 5332921 95817
    United States

    Active - Recruiting

  • Stanford Cancer Institute

    Stanford 5398563, California 5332921 94305
    United States

    Active - Recruiting

  • University of Colorado Cancer Center

    Aurora, Colorado 80045
    United States

    Site Not Available

  • University of Colorado Cancer Center

    Aurora 5412347, Colorado 5417618 80045
    United States

    Active - Recruiting

  • Florida Cancer Specialists

    Sarasota, Florida 34232
    United States

    Site Not Available

  • Moffitt Cancer Center and Research Institute

    Tampa, Florida 33612
    United States

    Site Not Available

  • Florida Cancer Specialists

    Sarasota 4172131, Florida 4155751 34232
    United States

    Active - Recruiting

  • Moffitt Cancer Center and Research Institute

    Tampa 4174757, Florida 4155751 33612
    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

  • Henry Ford Cancer

    Detroit, Michigan 48202
    United States

    Site Not Available

  • START Midwest

    Grand Rapids, Michigan 49546
    United States

    Site Not Available

  • Henry Ford Cancer

    Detroit 4990729, Michigan 5001836 48202
    United States

    Active - Recruiting

  • START Midwest

    Grand Rapids 4994358, Michigan 5001836 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

    Site Not Available

  • NYU Langone Health

    New York, New York 10032
    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 10065
    United States

    Active - Recruiting

  • NYU Langone Health

    New York 5128581, New York 5128638 10032
    United States

    Active - Recruiting

  • University of Oklahoma

    Oklahoma City, Oklahoma 73104
    United States

    Site Not Available

  • University of Oklahoma

    Oklahoma City 4544349, Oklahoma 4544379 73104
    United States

    Active - Recruiting

  • Sarah Cannon Research Institue

    Nashville, Tennessee 37203
    United States

    Site Not Available

  • Sarah Cannon Research Institue

    Nashville 4644585, Tennessee 4662168 37203
    United States

    Active - Recruiting

  • Mary Crowley Cancer Research

    Dallas, Texas 75230
    United States

    Site Not Available

  • MD Anderson

    Houston, Texas 77030
    United States

    Site Not Available

  • NEXT Dallas

    Irving, Texas 75039
    United States

    Site Not Available

  • NEXT Oncology San Antonio

    San Antonio, Texas 78229
    United States

    Active - Recruiting

  • START Texas

    San Antonio, Texas 78229
    United States

    Site Not Available

  • Mary Crowley Cancer Research

    Dallas 4684888, Texas 4736286 75230
    United States

    Completed

  • MD Anderson

    Houston 4699066, Texas 4736286 77030
    United States

    Active - Recruiting

  • NEXT Dallas

    Irving 4700168, Texas 4736286 75039
    United States

    Active - Recruiting

  • NEXT Oncology San Antonio

    San Antonio 4726206, Texas 4736286 78229
    United States

    Active - Recruiting

  • START Texas

    San Antonio 4726206, Texas 4736286 78229
    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

  • Medical College of Wisconsin

    Milwaukee, Wisconsin 53226
    United States

    Site Not Available

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