Phase 3 Study of Zoldonrasib (RMC-9805) Plus Daraxonrasib (RMC 6236) Versus Gemcitabine and Nab-Paclitaxel as First-Line Treatment in Metastatic KRAS G12D-Mutated Pancreatic Adenocarcinoma

Prior treatment

• Mutation status with previously known driver mutations for which there are approved targeted therapies (eg, BRCA1/BRCA2, microsatellite-instability high/mismatch repair deficient, and NTRK gene fusion).
• Prior therapy with a MAPK-pathway targeted therapy
• Major surgery within 28 days prior to randomization

Other illness

• Active or known history of untreated central nervous system (CNS) metastatic or leptomeningeal disease.
• Any conditions that may affect the ability to take or absorb study drug

Other

• Patient is unable or unwilling to comply with protocol-required study visits or procedures

• At least 18 years of age (or age greater than or equal to regionally approved age of consent for participation in investigational clinical studies) at the time of signing informed consent form (ICF).
• ECOG performance status (ECOG performance status) 0 or 1.
• Definitive histologically or cytologically confirmed pancreatic adenocarcinoma,including adenosquamous carcinoma
• Initial diagnosis of metastatic disease occurring ≤ 6 weeks prior to informed consent
• No prior treatment of pancreatic adenocarcinoma in the locally advanced unresectable or metastatic setting with systemic anticancer therapy • Prior treatment with systemic anticancer therapy given in the neoadjuvant or adjuvant setting, if given in combination with surgical resection, is allowed if completed ≥ 6 months prior to diagnosis of metastatic disease
• Measurable metastatic disease per RECIST v1.1
• Documented KRAS G12D mutation mutations identified by a validated assay
• Availability of protocol‑specified tumour tissue.
• Adequate organ function (bone marrow, liver, kidney, coagulation).