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

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 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 mutationsdefined as nonsynonymous mutations in KRAS, NRAS, or HRAS at codons 12, 13, or 61 (G12, G13, or Q61).

• Able to take oral medications.

Exclusion Criteria:

• 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 orprocedures