RecruitingPhase 3NCT07252232

Study of Daraxonrasib (RMC-6236) in Patients With Resected Pancreatic Ductal Adenocarcinoma (PDAC)

RASolute 304: A Phase 3 Multicenter, Open-label, Randomized, 2-Arm Study of Adjuvant Daraxonrasib Versus Standard of Care Observation Following Completion of Neoadjuvant and/or Adjuvant Chemotherapy in Patients With Resected Pancreatic Ductal Adenocarcinoma (PDAC)

Sponsor

Revolution Medicines, Inc.

Enrollment

500 participants

Start Date

Dec 15, 2025

Study Type

INTERVENTIONAL

Conditions

Pancreatic Cancer PDAC PDAC - Pancreatic Ductal Adenocarcinoma Resectable Pancreatic Ductal Adenocarcinoma (PDAC)Resected Pancreatic Adenocarcinoma

Summary

The purpose of this study is to evaluate the safety and efficacy of a novel RAS(ON) inhibitor compared to standard of care (SOC) observation only.

Eligibility

Min Age: 18 Years

Inclusion Criteria8

At least 18 years old and has provided informed consent.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Histologically confirmed PDAC with successful (R0/R1) curative intent surgical resection and no evidence of recurrent or metastatic disease.
Must have received perioperative (neoadjuvant, adjuvant, or a combination of both) multi-agent chemotherapy.
Must have completed most recent treatment within the past 12 weeks.
Adequate organ function (bone marrow, liver, kidney, coagulation).
Documented RAS mutation status.
Able to take oral medications.

Exclusion Criteria4

Prior therapy with direct RAS-targeted therapy (eg. degraders and/or inhibitors).
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.

Interventions

DRUGdaraxonrasib

oral tablets

Locations(7)

Hartford Healthcare

Hartford, Connecticut, United States

Community Health Network

Indianapolis, Indiana, United States

Saint Luke's Cancer Institute

Kansas City, Missouri, United States

Taylor Cancer Research Center

Maumee, Ohio, United States

Avera Cancer Institute

Sioux Falls, South Dakota, United States

Virginia Cancer Specialists

Fairfax, Virginia, United States

Pan American Oncology Trials, LLC

San Juan, Puerto Rico, Puerto Rico

View Full Details on ClinicalTrials.gov

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NCT07252232

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