Phase 3 Study of Chemotherapy With or Without INCB161734 for Untreated KRAS G12D-Mutated Metastatic Pancreatic Cancer

What this Trial Is About

Researchers are evaluating the effectiveness and safety of standard chemotherapy with or without the drug INCB161734 in participants who have metastatic pancreatic ductal adenocarcinoma PDAC with a KRAS G12D mutation and have not received prior treatment for metastatic disease. This phase 3 study compares two groups to understand whether adding INCB161734 to chemotherapy improves outcomes in this condition. Participants will receive either oral INCB161734 tablets combined with chemotherapy chosen by their doctor either mFOLFIRINOX or GemNabP or a placebo tablet combined with the same chemotherapy options. The treatments are given according to the study protocol, and the study is conducted in a randomized, double-blind design to fairly compare the effects of INCB161734 plus chemotherapy versus placebo plus chemotherapy. During the study, participants will be monitored for overall survival, progression-free survival, and tumor response up to about two to three years. Researchers will also assess treatment side effects, quality of life using questionnaires, and other health outcomes. Participants will have regular visits for assessments, and safety will be closely tracked throughout the study period, which lasts until the study completion date in 2029.

A Study to Evaluate Chemotherapy With or Without INCB161734 in Previously Untreated, KRAS G12D-Mutated Metastatic Pancreatic Ductal Adenocarcinoma