Phase 3 Study of Daraxonrasib Alone or with Chemotherapy Compared to Standard Chemotherapy for First-Line Treatment of Metastatic Pancreatic Adenocarcinoma

What this Trial Is About

Researchers are evaluating the safety and efficacy of an investigational drug called daraxonrasib, given alone or combined with gemcitabine and nab-paclitaxel chemotherapy, compared with standard chemotherapy alone. This Phase 3, global, randomized, and open-label study focuses on patients with metastatic pancreatic adenocarcinoma. The goal is to see if these treatments improve progression-free survival and overall survival as first-line therapy. Participants will be randomly assigned to one of three groups daraxonrasib alone, daraxonrasib combined with gemcitabine and nab-paclitaxel, or gemcitabine and nab-paclitaxel alone. Daraxonrasib is taken as oral tablets, while gemcitabine and nab-paclitaxel are given by intravenous infusion. Treatment cycles last 28 days, and drug concentration is assessed up to the fifth cycle. Throughout the study, participants will undergo regular assessments that include measuring tumor response, health-related quality of life questionnaires, monitoring adverse events, vital signs, and laboratory tests. The main outcomes measured are progression-free and overall survival up to about two years. The total study duration spans from March 2026 to March 2029, with safety and efficacy closely followed during this time.

Study of Daraxonrasib and Daraxonrasib + GnP as First-line Treatment in Patients With Metastatic Pancreatic Adenocarcinoma