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

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.

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.

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.

Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT07252232.

State:

Memorial Sloan Kettering Cancer Center

Status: Active

Name Not Available

Huntsman Cancer Institute/University of Utah

Status: Active

Name Not Available

This is a global, randomized, open-label, Phase 3 study designed to evaluate whether

treatment with daraxonrasib will improve disease-free survival (DFS) compared to SOC

observation in patients with resected PDAC who have completed neoadjuvant and/or adjuvant

chemotherapy.

Trial PhasePhase III

Trial Typetreatment

Lead OrganizationRevolution Medicines

Description