Core Viewpoint - Actuate Therapeutics has initiated a Phase 1b clinical trial to evaluate the combination of elraglusib, retifanlimab, and modified FOLFIRINOX as a frontline therapy for advanced pancreatic adenocarcinoma, aiming to address unmet medical needs in this challenging cancer type [1][4]. Group 1: Clinical Trial Details - The Phase 1b trial, named RiLEY (NCT06896188), will enroll up to 12 patients initially, with plans for expansion based on interim efficacy results [2]. - The primary objective is to determine the recommended phase 2 dose (RP2D) for the combination regimen, while secondary objectives include evaluating overall response rate (ORR), disease control rate (DCR), median progression-free survival (mPFS), overall survival (OS), and safety [2]. Group 2: Mechanism and Previous Results - The combination therapy is expected to provide a synergistic immune-modulatory approach, enhancing anti-tumor responses by targeting multiple immune checkpoints [3]. - Previous studies indicated that elraglusib combined with gemcitabine/nab-paclitaxel resulted in a significant increase in median overall survival, a 37% reduction in the risk of death, and a doubling of the 12-month survival rate in patients with metastatic pancreatic adenocarcinoma [3]. Group 3: Company Strategy and Future Plans - The collaboration with UPMC Hillman Cancer Center and Incyte aims to explore new synergistic opportunities for patients who have not yet received systemic therapy, enhancing both efficacy and durability of response [4]. - Actuate is also conducting a separate Phase 2 trial (NCT05077800) studying elraglusib in combination with FOLFIRINOX and losartan, with initial data showing promising results in patients with extensive liver metastases [4].