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

NCT07491445 · tracked via the Priya Life Science UK tracker

Sponsor

Revolution Medicines, Inc.

Phase

Phase 3

Started

2026-03-09

Last updated

2026-09-14

Condition(s) studied

Pancreatic CancerPancreatic Cancer MetastaticPDACPDAC - Pancreatic Ductal AdenocarcinomaPancreatic Ductal Adenocarcinoma (PDAC)Pancreatic Adenocarcinoma MetastaticPancreatic AdenocarcinomaPancreatic Adenosquamous Carcinoma

Investigational drug(s) / intervention(s)

daraxonrasibgemcitabinenab-paclitaxel

daraxonrasib: oral tablets

gemcitabine: intravenous (IV) infusion

nab-paclitaxel: IV infusion

Study 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

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: * At least 18 years old and has provided informed consent. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. * Histologically or cytologically confirmed pancreatic adenocarcinoma. * Diagnosis of metastatic disease ≤ 6 weeks prior to informed consent. * Documented RAS mutation status, either mutant or wild-type. * Measurable disease per RECIST v1.1. * Adequate organ function (bone marrow, liver, kidney, coagulation). * Able to take oral medications. Exclusion Criteria: * Prior treatment with systemic anticancer therapy in metastatic setting or prior RAS-targeted therapy in any treatment setting. * Active or known history of untreated central nervous system metastatic disease. * Any conditions that may affect the ability to take or absorb study drug. * Major surgery within 28 days prior to randomization. * Patient is unable or unwilling to comply with protocol-required study visits or procedures.

Primary outcome measure(s)

Progression free survival (PFS) — Up to approximately 2 years
PFS is defined as the time from randomization until disease progression or death from any cause, whichever occurs first. Progression is per response evaluation criteria in solid tumors (RECIST) v1.1 and as assessed by Investigator.
Overall survival (OS) — Up to approximately 2 years
OS is defined as the time from randomization until death from any cause.

Trial sites (49)

Facility	City	Region	Status
Mayo Clinic - Scottsdale	Phoenix	Arizona	Recruiting
Honor Health Research Institute	Scottsdale	Arizona	Recruiting
University of California Los Angeles Health - Hematology/Oncology	Los Angeles	California	Recruiting
University of California San Francisco	San Francisco	California	Recruiting
Mayo Clinic Cancer Center- Florida	Jacksonville	Florida	Recruiting
H Lee Moffitt Cancer Center and Research Institute	Tampa	Florida	Recruiting
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center	Baltimore	Maryland	Recruiting
Dana-Farber Cancer Institute	Boston	Massachusetts	Recruiting
Mayo Clinic Cancer Center- Rochester	Rochester	Minnesota	Recruiting
Comprehensive Cancer Centers of Nevada	Henderson	Nevada	Active Not Recruiting
Memorial Sloan Kettering Cancer Center	New York	New York	Recruiting
Duke University Medical Center	Durham	North Carolina	Recruiting
University of Cincinnati Cancer Center	Cincinnati	Ohio	Recruiting
Taylor Cancer Research Center	Maumee	Ohio	Active Not Recruiting
SCRI Oncology Partners	Nashville	Tennessee	Recruiting
SCRI - Texas Oncology Dallas	Dallas	Texas	Recruiting
MD Anderson Cancer Center	Houston	Texas	Recruiting
Huntsman Cancer Institute	Salt Lake City	Utah	Recruiting
Virginia Cancer Specialists	Fairfax	Virginia	Recruiting
Virginia Mason Medical Center	Seattle	Washington	Recruiting
Prince of Wales Hospital	Randwick	New South Wales	Recruiting
Calvary Mater Newcastle	Waratah	New South Wales	Recruiting
Epworth HealthCare	East Melbourne	Victoria	Recruiting
Krankenhaus der Barmherzigen Brüder Wien-Klinisch wissenschaftliche Studien	Vienna	Austria	Recruiting
CEPON - Centro de Pesquisa Oncologicas de Santa Catarina	Florianópolis	Santa Catarina	Recruiting
CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia	São Paulo	Brazil	Recruiting
Princess Margaret Cancer Centre	Toronto	Ontario	Recruiting
McGill University - Dept. Oncology Clinical Research Program	Montreal	Quebec	Recruiting
National Cancer Center - East	Kashiwa	Chiba	Recruiting
Cancer Institute Hospital - Japan Foundation for Cancer Research	Koto-Ku	Tokyo	Recruiting
Chiba Cancer Center	Chiba	Japan	Recruiting
NHO Kyushu Cancer Center	Fukuoka	Japan	Recruiting
Kyushu University Hospital	Fukuoka	Japan	Recruiting
Kanagawa Cancer Canter	Kanagawa	Japan	Recruiting
Osaka International Cancer Institute	Osaka	Japan	Recruiting
National Cancer Center - Tokyo	Tokyo	Japan	Recruiting
Wakayama Medical University Hospital	Wakayama	Japan	Recruiting
Yamaguchi University Hospital	Yamaguchi	Japan	Recruiting
Curie Oncology Pte Ltd	Singapore	Singapore	Recruiting
Seoul National University Hospital	Seoul	South Korea	Recruiting

+ 9 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07491445 on ClinicalTrials.gov ↗ ← All trials in the UK