Phase Ib Study of 9-ING-41 and Retifanlimab with Modified FOLFIRINOX as First Treatment for Advanced Pancreatic Adenocarcinoma

What this Trial Is About

Researchers are studying a combination treatment involving 9-ING-41 elraglusib, retifanlimab, and modified FOLFIRINOX chemotherapy in patients with advanced pancreatic adenocarcinoma who have not received prior systemic therapy for their advanced disease. This Phase 1b study aims to evaluate the safety, tolerability, and potential anti-tumor activity of these combined therapies, as 9-ING-41 inhibits GSK-3 which may enhance immune response when combined with a PD-1 inhibitor like retifanlimab. The study builds on previous positive safety and efficacy data for each agent separately but seeks to understand their combined effects. The treatment involves chemotherapy with oxaliplatin, leucovorin, irinotecan, and 5-FU administered every 14 days, retifanlimab given by IV infusion at 500 mg on day 1 of every other cycle, and 9-ING-41 given intravenously twice weekly for the first four cycles then weekly thereafter. The study starts with a safety lead-in cohort of 6 patients to assess dose-limiting toxicities and may adjust doses accordingly before expanding to a larger group up to 12 patients total. This combination has not been previously tested together in humans. Participants will undergo scheduled visits with laboratory tests and imaging to monitor treatment safety and tumor response. Researchers will track dose-limiting toxicities within 28 days of treatment start and measure disease control rates, response rates, progression-free survival, overall survival, and treatment-related adverse events over months to years. The study includes detailed monitoring of lab function, performance status, and tumor measurements to assess outcomes and safety during follow-up periods up to 42 months.

9-ING-41 Combined With Retifanlimab, Plus Modified FOLFIRINOX for Patients With Advanced Pancreatic Adenocarcinoma (RiLEY)