RecruitingPhase 1Phase 2NCT06128551

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

Phase 1b/2, Multicenter, Open-label, Dose Escalation and Dose Expansion Study of Elironrasib and Daraxonrasib as Monotherapies and Combination Therapy in Patients With Advanced KRAS G12C-Mutated Solid Tumors

Sponsor

Revolution Medicines, Inc.

Enrollment

534 participants

Start Date

Nov 14, 2023

Study Type

INTERVENTIONAL

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is studying two experimental drugs — Elironrasib and Daraxonrasib — alone and in combination in patients with advanced solid tumors that have a specific mutation called KRAS G12C. This mutation is found in certain lung, colon, and other cancers and makes tumors difficult to treat. **You may be eligible if:** - You are 18 or older - Your cancer has been confirmed to have the KRAS G12C mutation and cannot be cured - You have already received standard treatments (chemotherapy, immunotherapy, and/or prior KRAS G12C inhibitors depending on which part of the trial you enter) - You have good physical functioning (ECOG score 0–1) - Your organ function is adequate **You may NOT be eligible if:** - You have a primary brain tumor - You have active brain metastases - You have gut conditions that affect how drugs are absorbed - You have had major surgery within the past 28 days Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGElironrasib

oral tablets

DRUGDaraxonrasib

oral tablets

Locations(53)

City of Hope

Duarte, California, United States

UC IRVINE Health

Orange, California, United States

UC Davis Comprehensive Cancer Center

Sacramento, California, United States

Stanford Cancer Institute

Stanford, California, United States

University of Colorado Cancer Center

Aurora, Colorado, United States

Florida Cancer Specialists

Sarasota, Florida, United States

Moffitt Cancer Center and Research Institute

Tampa, Florida, United States

Dana Farber Cancer Institute

Boston, Massachusetts, United States

Henry Ford Cancer

Detroit, Michigan, United States

START Midwest

Grand Rapids, Michigan, United States

Columbia University

New York, New York, United States

NYU Langone Health

New York, New York, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

University of Oklahoma

Oklahoma City, Oklahoma, United States

Sarah Cannon Research Institue

Nashville, Tennessee, United States

Mary Crowley Cancer Research

Dallas, Texas, United States

MD Anderson

Houston, Texas, United States

NEXT Dallas

Irving, Texas, United States

NEXT Oncology San Antonio

San Antonio, Texas, United States

START Texas

San Antonio, Texas, United States

NEXT Oncology Virginia

Fairfax, Virginia, United States

West Cancer Institute

Angers, France

Institut Bergonie

Bordeaux, France

Hospital Louise Pradel

Bron, France

Oscar Lambret Center of Lillle

Lille, France

Centre Leon Berard

Lyon, France

Cancer Institute of Montpellier

Montpellier, France

CHU Nantes

Nantes, France

Institute of Cancer of Strasbourg

Strasbourg, France

Universitäts Klinikum Köln

Cologne, Germany

Klinikum Esslingen GmbH

Esslingen am Neckar, Germany

Krankenhaus Bethanien Moers

Moers, Germany

Klinkum Nurnberg Paracelsus Medical Unviersity

Nuremberg, Germany

Department of Medical Oncology - Azienda Ospedaliero Uniersitaria delle Marche

Ancona, Italy

Centro Di Riferimento Oncologico

Aviano, Italy

Institute Romagnolo per lo Studio Tumori

Meldola, Italy

Niguarda Cancer Center

Milan, Italy

Istituto Nazionale Tumori IRCCS Fondazione "G. Pascale"

Naples, Italy

San Luigi Hospital

Orbassano, Italy

AUSL Romagna - S.M. delle Croci Hospital

Ravenna, Italy

Netherlands Cancer Institute Antoni van Leeuwenhoek

Amsterdam, Netherlands

Pan American Center for Oncology Trials

San Juan, Puerto Rico

START Barcelona - Hospital HM Nou Delfos

Barcelona, Spain

Institut Catala d'Oncologia Hospital

Barcelona, Spain

University Clinic of Navarra

Madrid, Spain

Fundacion MD Anderson Cancer Center

Madrid, Spain

START Madrid

Madrid, Spain

Hospital Universitario 12 de Octubre

Madrid, Spain

NEXT Oncology - Quirónsalud Madrid University Hospital

Madrid, Spain

University Clinic of Navarra

Pamplona, Spain

Hospital Universitario Virgen Macarena

Seville, Spain

La Fe University and Polytechnic Hospital

Valencia, Spain

Hospital Universitario Miguel Servet

Zaragoza, Spain

View Full Details on ClinicalTrials.gov

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NCT06128551