Clinical Trials | A Phase 3, Double-blind, Placebo-controlled, Randomized Study to Assess the Efficacy and Safety of ASP3082 in Combination with mFOLFIRINOX or NALIRIFOX as First-line Treatment in Participants with KRAS G12D-mutated Metastatic Pancreatic Adenocarcinoma

The University of Virginia is conducting a clinical research study for adults ages 18 and over who have metastatic pancreatic ductal adenocarcinoma cancer (PDAC) with a KRAS G12D mutation. The purpose of this study is to see if the investigational study drug, ASP3082 is safe and effective as a treatment for people who have metastatic pancreatic ductal adenocarcinoma cancer (PDAC) with a KRAS G12D mutation when combined with chemotherapy and as compared to placebo (an inactive substance that looks like the study drug) combined with chemotherapy. This study has two treatment groups. You will be assigned randomly (by chance, like flipping a coin) to 1 of 2 treatment groups. • ASP3082 + mFOLFIRINOX/ NALIRIFOX (chemotherapy) • Placebo (inactive substance that looks like the study drug + mFOLFIRINOX/ NALIRIFOX This is a double-blind study, which means neither you not your study doctor will know which study group you are in (although your study doctor can find out which group you are in for serious medical reasons). You will receive ASP3082 or the placebo via an IV infusion once weekly in every 28 day cycle. mFOLFIRINOX/ NALIRIFOX will also be administered via an IV infusion either 2 days prior to and up to 7 days after administration of ASP3082 or placebo. You will receive study treatment for as long as your cancer is responding to the treatment. The anticipated duration of the study is approximately 17 months. Study-related procedures that are being done beyond your standard of care will be provided at no cost to you or your insurance.