Phase 3 Study Comparing Zoldonrasib Plus Chemotherapy Versus Placebo Plus Chemotherapy for First-line Treatment of Metastatic KRAS G12D-mutated Pancreatic Adenocarcinoma

What this Trial Is About

Researchers are evaluating the effectiveness of an investigational drug called zoldonrasib combined with chemotherapy, compared to a placebo combined with chemotherapy, for patients with metastatic pancreatic adenocarcinoma who have a specific KRAS G12D mutation. This is a Phase 3, global, randomized, double-blind study aiming to see if zoldonrasib plus chemotherapy improves progression-free survival or overall survival in previously untreated patients. Participants will be randomly assigned to one of two groups one group receives zoldonrasib with the investigators choice of chemotherapy either modified FOLFIRINOX or gemcitabine plus nab-paclitaxel, and the other group receives a placebo with the same chemotherapy options. Chemotherapy choice is determined by the investigator, and the study drug and placebo are given as oral tablets alongside chemotherapy infusions. During the study, participants will be monitored for up to approximately 4 years. Assessments include progression-free survival, overall survival, response rates, adverse events, vital signs, laboratory tests, and quality of life questionnaires focused on pancreatic cancer symptoms and general health. The concentration of zoldonrasib will also be measured early in treatment. Regular visits and evaluations will help researchers understand how well the treatments work and their safety over time.

Study of Zoldonrasib + Chemo of Investigator's Choice vs Placebo + Chemo of Investigator's Choice as First-line Treatment in Metastatic KRAS G12D-mutated Pancreatic Adenocarcinoma ( RASolute 305 )