A Phase 3, Randomized, Open-Label Study of Zoldonrasib (RMC-9805) Plus Daraxonrasib (RMC-6236) Versus Gemcitabine and Nab-Paclitaxel as First-Line Treatment in Patients with Metastatic KRAS G12D-Mutated Pancreatic Adenocarcinoma (RASolute 309)

Condition studied

Pancreatic Adenocarcinoma

Investigational medicinal product(s)

Every trial of RMC-9805, Cetuximab, Gemcitabine and Paclitaxel across our registers →

Eligibility

Primary endpoint

PFS, defined as the time from randomization until disease progression or death from any cause, whichever occurs first. Progression is assessed per RECIST v1.1 by Investigator, OS, defined as the time from randomization until death from any cause

Endpoint detail

PFS, defined as the time from randomization until disease progression or death from any cause, whichever occurs first. Progression is assessed per RECIST v1.1 by BICR, Objective response of PR or CR per RECIST v1.1, as assessed by Investigator, DOR, defined as the time from first evidence of objective response (PR or CR) per RECIST v1.1 to disease progression or death due to any cause, whichever occurs first, as assessed by Investigator, Incidence and severity of TEAEs, TRAEs, and SAEs, Change from baseline in clinical laboratory tests and vital signs, Predose and postdose blood concentrations of zoldonrasib and daraxonrasib, Change from baseline on the EORTC QLQ-PAN26 pain scale, Change from baseline on the EORTC QLQ-C30 global health status score