NCT06128551PHASE1, PHASE2Recruiting

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

Revolution Medicines, Inc.

Start Date

11/14/2023

Completion Date

6/1/2029

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.

Detailed 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.

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: * 18 years of age * Histology: pathologically documented, KRAS G12C-mutated, advanced or metastatic solid 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 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 procedures within 7 days of treatment

Interventions

DRUG

Elironrasib

DRUG

Daraxonrasib

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Conditions

Non-Small Cell Lung Cancer (NSCLC)Colorectal CancerPancreatic Ductal Adenocarcinoma

Locations

City of Hope

Duarte, California 91010

United States

UC IRVINE Health

Orange, California 92868

United States

UC Davis Comprehensive Cancer Center

Sacramento, California 95817

United States

Stanford Cancer Institute

Stanford, California 94305

United States

University of Colorado Cancer Center

Aurora, Colorado 80045

United States

Florida Cancer Specialists

Sarasota, Florida 34232

United States

Moffitt Cancer Center and Research Institute

Tampa, Florida 33612

United States

Dana Farber Cancer Institute

Boston, Massachusetts 02215

United States

Henry Ford Cancer

Detroit, Michigan 48202

United States

START Midwest

Grand Rapids, Michigan 49546

United States

Columbia University

New York, New York 10032

United States

NYU Langone Health

New York, New York 10032

United States

Memorial Sloan Kettering Cancer Center

New York, New York 10065

United States

University of Oklahoma

Oklahoma City, Oklahoma 73104

United States

Sarah Cannon Research Institue

Nashville, Tennessee 37203

United States

Mary Crowley Cancer Research

Dallas, Texas 75230

United States

MD Anderson

Houston, Texas 77030

United States

NEXT Dallas

Irving, Texas 75039

United States

NEXT Oncology San Antonio

San Antonio, Texas 78229

United States

START Texas

San Antonio, Texas 78229

United States

NEXT Oncology Virginia

Fairfax, Virginia 22031

United States

West Cancer Institute

Angers, 49055

France

Institut Bergonie

Bordeaux, 33000

France

Hospital Louise Pradel

Bron, 69500

France

Oscar Lambret Center of Lillle

Lille, 59000

France

Centre Leon Berard

Lyon, 69373

France

Cancer Institute of Montpellier

Montpellier, 34298

France

CHU Nantes

Nantes, 44093

France

Institute of Cancer of Strasbourg

Strasbourg, 67033

France

Universitäts Klinikum Köln

Cologne, 80937

Germany

Klinikum Esslingen GmbH

Esslingen am Neckar, 73730

Germany

Krankenhaus Bethanien Moers

Moers, 47441

Germany

Klinkum Nurnberg Paracelsus Medical Unviersity

Nuremberg, 90419

Germany

Department of Medical Oncology - Azienda Ospedaliero Uniersitaria delle Marche

Ancona, 60126

Italy

Centro Di Riferimento Oncologico

Aviano, 33081

Italy

Institute Romagnolo per lo Studio Tumori

Meldola, 47014

Italy

Niguarda Cancer Center

Milan, 20162

Italy

Istituto Nazionale Tumori IRCCS Fondazione "G. Pascale"

Naples, 80131

Italy

San Luigi Hospital

Orbassano, 10043

Italy

AUSL Romagna - S.M. delle Croci Hospital

Ravenna, 48121

Italy

Netherlands Cancer Institute Antoni van Leeuwenhoek

Amsterdam, 1066CX

Netherlands

Pan American Center for Oncology Trials

San Juan, 00935

Puerto Rico

START Barcelona - Hospital HM Nou Delfos

Barcelona, 08023

Spain

Institut Catala d'Oncologia Hospital

Barcelona, 08908

Spain

University Clinic of Navarra

Madrid, 28027

Spain

Fundacion MD Anderson Cancer Center

Madrid, 28033

Spain

START Madrid

Madrid, 28040

Spain

Hospital Universitario 12 de Octubre

Madrid, 28041

Spain

NEXT Oncology - Quirónsalud Madrid University Hospital

Madrid, 28223

Spain

University Clinic of Navarra

Pamplona, 31008

Spain

Hospital Universitario Virgen Macarena

Seville, 41009

Spain

La Fe University and Polytechnic Hospital

Valencia, 46026

Spain

Hospital Universitario Miguel Servet

Zaragoza, 50009

Spain