Recruiting

Phase 3

RAS(ON) InhibitorStudy of Daraxonrasib and Daraxonrasib + GnP as First-line Treatment in Patients With Metastatic Pancreatic Adenocarcinoma

Sponsor:

Revolution Medicines, Inc.

Code:

NCT07491445

Conditions

Pancreatic Cancer

Pancreatic Cancer Metastatic

PDAC

PDAC - Pancreatic Ductal Adenocarcinoma

Pancreatic Ductal Adenocarcinoma (PDAC)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

daraxonrasib

gemcitabine

nab-paclitaxel

Study Details

Brief 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.

Conditions

Pancreatic Cancer

Pancreatic Cancer Metastatic

PDAC

PDAC - Pancreatic Ductal Adenocarcinoma

Pancreatic Ductal Adenocarcinoma (PDAC)

Study ID

NCT07491445

Start date

Mar 9, 2026

Status verified date

Aug, 2026

Completion date

Mar, 2029

Anticipated

Primary completion date

Jun, 2028

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

900 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Arm A: daraxonrasib

study drug

experimental: Arm B: daraxonrasib + gemcitabine and nab-paclitaxel

study drug in combination with chemotherapy

active comparator: Arm C: gemcitabine and nab-paclitaxel

SOC chemotherapy

Interventions

daraxonrasib

oral tablets

gemcitabine

intravenous (IV) infusion

nab-paclitaxel

IV infusion

Primary outcome measure

Progression free survival (PFS) [ Time Frame: Up to approximately 2 years ]
Overall survival (OS) [ Time Frame: Up to approximately 2 years ]

Central Contacts and Locations

Central contacts

Revolution Medicines Study Director

1-844-2-REVMED medinfo@revmed.com

Locations

Honor Health Research Institute

Recruiting

Scottsdale, Arizona, United States, 85258

Contacts

Carolina Robertson

carobertson@honorhealth.com

University of California San Francisco

Recruiting

San Francisco, California, United States, 94158

Contacts

Kevin Lopez

415-353-7070

H Lee Moffitt Cancer Center and Research Institute

Recruiting

Tampa, Florida, United States, 33612

Contacts

Cheyenne Schneider

813-745-3691 cheyenne.schneider@moffitt.org

Johns Hopkins Sidney Kimmel Comprehensive Cancer Center

Recruiting

Baltimore, Maryland, United States, 21287

Contacts

Colleen Apostol

410-614-3644 giclinicaltrials@jhmi.edu

Dana-Farber Cancer Institute

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Danielle Lindquist

857-215-2351 DanielleA_Lindquist@DFCI.HARVARD.EDU

Memorial Sloan Kettering Cancer Center

Recruiting

New York, New York, United States, 10065

Contacts

Wungki Park

646-888-4543 parkw1@mskcc.org

University of Cincinnati Cancer Center

Recruiting

Cincinnati, Ohio, United States, 45219

Contacts

Alexis Brenner

513-584-5725 brenneas@ucmail.uc.edu

SCRI Oncology Partners

Recruiting

Nashville, Tennessee, United States, 37203

Contacts

Karlie Williams

615-329-7274 karlie.williams@scri.com

SCRI - Texas Oncology Dallas

Recruiting

Dallas, Texas, United States, 95246

Contacts

Christine Terraciano

214-370-1000 christine.terraciano@usoncology.com

MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Kamisha Jernigan

giclinicaltrials@mdanderson.org

Huntsman Cancer Institute

Recruiting

Salt Lake City, Utah, United States, 84112

Virginia Cancer Specialists

Recruiting

Fairfax, Virginia, United States, 22031

Contacts

Carrie Friedman

571-350-8400 carrie.friedman@usoncology.com

Virginia Mason Medical Center

Recruiting

Seattle, Washington, United States, 98101

Contacts

Das Rishika

206-287-6273 rishika.das@commonspirit.org

More Information

Sponsor

Revolution Medicines, Inc.

Last update posted

Aug 27, 2026

Last verified

Aug, 2026

Keywords

Pancreatic Cancer
PDAC
Pancreatic Ductal Adenocarcinoma
RAS
KRAS
NRAS
HRAS
RAS Wild-Type
RAS Mutation
Pancreatic Cancer Metastatic
Pancreatic Adenocarcinoma Metastatic
Pancreatic Adenosquamous Carcinoma
Pancreatic Adenocarcinoma

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Revolution Medicines, Inc. on 2026-08-27.