Open Actively Recruiting

Phase 3 Study of Daraxonrasib (RMC-6236) in Patients with Previously Treated Metastatic Pancreatic Ductal Adenocarcinoma (PDAC)

About

Brief Summary

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

Primary Purpose

Treatment

Study Type

Interventional

Phase

Phase 3

Gender

All

Healthy Volunteers

Minimum Age

18 Years

Maximum Age

N/A

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 PDAC with metastatic disease.
Measurable disease per RECIST 1.1.
Adequate organ function (bone marrow, liver, kidney, coagulation)
Documented RAS mutation status, either mutant or wild-type. Eligible RAS mutations defined as nonsynonymous mutations in KRAS, NRAS, or HRAS at codons 12, 13, or 61 (G12, G13, or Q61).
Able to take oral medications.

Prior therapy with direct RAS-targeted therapy (eg. degraders and/or inhibitors).
History of or known central nervous system metastatic disease.
Any conditions that may affect the ability to take or absorb study treatment
Major surgery within 4 weeks prior to randomization.
Patient is unable or unwilling to comply with protocol-required study visits or procedures