RecruitingPhase 3NCT07491445

Study of Daraxonrasib and Daraxonrasib + GnP as First-line Treatment in Patients With Metastatic Pancreatic Adenocarcinoma

RASolute 303: A Phase 3 Global, Multicenter, Open-label, Randomized, 3-Arm Study of Daraxonrasib Monotherapy or Daraxonrasib Plus Gemcitabine and Nab-paclitaxel Versus Gemcitabine and Nab-paclitaxel as a First-Line Treatment for Patients With Metastatic Pancreatic Adenocarcinoma

Sponsor

Revolution Medicines, Inc.

Enrollment

900 participants

Start Date

Mar 9, 2026

Study Type

INTERVENTIONAL

Conditions

Pancreatic Cancer Pancreatic Ductal Adenocarcinoma (PDAC)Pancreatic Adenocarcinoma Metastatic Pancreatic Adenocarcinoma PDAC PDAC - Pancreatic Ductal Adenocarcinoma Pancreatic Cancer Metastatic Pancreatic Adenosquamous Carcinoma

Summary

The purpose of this study is to evaluate the safety and efficacy of an investigational RAS(ON) inhibitor administered as monotherapy or in combination with chemotherapy, compared with standard of care (SOC) chemotherapy alone.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called daraxonrasib, a drug called gemcitabine, and others for people with pdac, pdac - pancreatic ductal adenocarcinoma, and other related conditions. The study is currently recruiting participants at 13 locations. People eligible for this study include aged 18 Years and older.

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

DRUGdaraxonrasib

oral tablets

DRUGgemcitabine

intravenous (IV) infusion

DRUGnab-paclitaxel

IV infusion

Locations(49)

Mayo Clinic - Scottsdale

Phoenix, Arizona, United States

Honor Health Research Institute

Scottsdale, Arizona, United States

University of California Los Angeles Health - Hematology/Oncology

Los Angeles, California, United States

University of California San Francisco

San Francisco, California, United States

Mayo Clinic Cancer Center- Florida

Jacksonville, Florida, United States

H Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, United States

Johns Hopkins Sidney Kimmel Comprehensive Cancer Center

Baltimore, Maryland, United States

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Mayo Clinic Cancer Center- Rochester

Rochester, Minnesota, United States

Comprehensive Cancer Centers of Nevada

Henderson, Nevada, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Duke University Medical Center

Durham, North Carolina, United States

University of Cincinnati Cancer Center

Cincinnati, Ohio, United States

Taylor Cancer Research Center

Maumee, Ohio, United States

SCRI Oncology Partners

Nashville, Tennessee, United States

SCRI - Texas Oncology Dallas

Dallas, Texas, United States

MD Anderson Cancer Center

Houston, Texas, United States

Huntsman Cancer Institute

Salt Lake City, Utah, United States

Virginia Cancer Specialists

Fairfax, Virginia, United States

Virginia Mason Medical Center

Seattle, Washington, United States

Prince of Wales Hospital

Randwick, New South Wales, Australia

Calvary Mater Newcastle

Waratah, New South Wales, Australia

Epworth HealthCare

East Melbourne, Victoria, Australia

Krankenhaus der Barmherzigen Brüder Wien-Klinisch wissenschaftliche Studien

Vienna, Austria

CEPON - Centro de Pesquisa Oncologicas de Santa Catarina

Florianópolis, Santa Catarina, Brazil

CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia

São Paulo, Brazil

Princess Margaret Cancer Centre

Toronto, Ontario, Canada

McGill University - Dept. Oncology Clinical Research Program

Montreal, Quebec, Canada

National Cancer Center - East

Kashiwa, Chiba, Japan

Cancer Institute Hospital - Japan Foundation for Cancer Research

Koto-Ku, Tokyo, Japan

Chiba Cancer Center

Chiba, Japan

NHO Kyushu Cancer Center

Fukuoka, Japan

Kyushu University Hospital

Fukuoka, Japan

Kanagawa Cancer Canter

Kanagawa, Japan

Osaka International Cancer Institute

Osaka, Japan

National Cancer Center - Tokyo

Tokyo, Japan

Wakayama Medical University Hospital

Wakayama, Japan

Yamaguchi University Hospital

Yamaguchi, Japan

Curie Oncology Pte Ltd

Singapore, Singapore

Seoul National University Hospital

Seoul, South Korea

Kaohsiung Medical University - Chung-Ho Memorial Hospital

Kaohsiung City, Taiwan

China Medical University Hospital

Taichung, Taiwan

National Taiwan University Hospital

Taipei, Taiwan

Torbay Hospital

Torquay, Devon, United Kingdom

Queen Elizabeth Hospital - Birmingham

Birmingham, United Kingdom

NHS Cambridge of Addenbrooke Hospital

Cambridge, United Kingdom

Barts Hospital

London, United Kingdom

Royal Marsden Hospital - London

London, United Kingdom

The Christie NHS Foundation Trust

Manchester, United Kingdom

View Full Details on ClinicalTrials.gov

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