Actuate Therapeutics Initiates Phase 1b Trial Of Elraglusib In Combination With Incyte's PD-1 Inhibitor, Retifanlimab, And Modified FOLFIRINOX As Frontline Therapy In Advanced Pancreatic Adenocarcinoma

• Clinical Trial Study to be Conducted at UPMC Hillman Cancer to Evaluate Novel Combination as Frontline Therapy

CHICAGO and FORT WORTH, Texas, Aug. 06, 2025 (GLOBE NEWSWIRE) -- Actuate Therapeutics, Inc. (NASDAQ:ACTU) ("Actuate" or the "Company"), a clinical-stage biopharmaceutical company focused on developing therapies for the treatment of high-impact, difficult-to-treat cancers through the inhibition of glycogen synthase kinase-3 beta (GSK-3β), today announced the initiation of the Phase 1b trial of elraglusib in combination with Incyte's PD-1 inhibitor, retifanlimab, and modified FOLFIRINOX (mFOLFIRINOX) as frontline therapy in advanced pancreatic adenocarcinoma. The trial is being conducted in collaboration with UPMC Hillman Cancer Center and Incyte Corporation.

The Investigator-Initiated Phase 1b open-label, single-arm RiLEY (NCT06896188) trial, led by Anwaar Saeed, MD, Associate Professor of Medicine, and Chief of the Gastrointestinal Medical Oncology at UPMC Hillman Cancer Center, will initially enroll up to 12 patients with advanced pancreatic adenocarcinoma with an expansion plan based on interim efficacy results. The primary objective of the trial is to determine the recommended phase 2 dose (RP2D) for the combination regimen, while the secondary objectives include evaluation of overall response rate (ORR), disease control rate (DCR), median progression-free survival (mPFS), overall survival (OS), and assessment of safety and tolerability.