Setidegrasib

Setidegrasib (ASP3082) is an investigational agent whose form is not stated in the registry developed by Astellas Pharma Global Development. Its target is KRAS (the sponsor names KRAS G12D). The sponsor states: Setidegrasib (ASP3082) is designed to stop the action of abnormal proteins produced by the KRAS G12D mutation; given as a weekly intravenous infusion combined with mFOLFIRINOX or NALIRIFOX chemotherapy in KRAS G12D-mutated metastatic pancreatic cancer, and versus docetaxel in KRAS G12D-mutated NSCLC. It is the investigational product in 2 recruiting or active industry-led phase 2 and phase 3 interventional cancer trials, including phase 3 studies NCT07409272 (A Study to Evaluate the Effectiveness and Safety of Setidegrasib, Given With Either mFOLFIRINOX or NALIRIFOX Chemotherapies, in People With Pancreatic Cancer) and NCT07566052 (A Study to Compare Setidegrasib (ASP3082) With Docetaxel, in People With Non-small Cell Lung Cancer With a KRAS G12D Mutation), in pancreatic ductal adenocarcinoma and non-small-cell lung cancer. The largest, NCT07409272, plans to enrol 614 participants with primary completion expected 2029-08-31. Status reflects the highest phase registered on ClinicalTrials.gov at the 2026-09-11 check; no efficacy results are recorded here.