Actuate Completes Enrollment For Phase 2 Trial In Pancreatic Cancer

Actuate Therapeutics has announced the successful completion of patient enrollment for its ongoing Phase 2 clinical trial, which is evaluating a combination therapy for metastatic pancreatic adenocarcinoma (mPDAC). The trial was led by Dr. Colin Weekes at Massachusetts General Hospital and supported by the Lustgarten Foundation. The trial explores the combination of FOLFIRINOX with elraglusib and losartan in previously untreated patients. Additional study sites include the University of Colorado and the Fred Hutchinson Cancer Center at the University of Washington.

“The completion of enrollment in this trial represents an important milestone in the development of elraglusib in metastatic pancreatic cancer. Initial data from this combination trial, as presented by Dr Weekes’ team at the AACR Special Conference on Advances in Pancreatic Cancer Research in September 2024, demonstrated early evidence of enhanced clinical activity when elraglusib was combined with FOLFIRINOX and losartan in patients with untreated mPDAC. We are proud to support this important trial and remain deeply committed to advancing elraglusib for patients with advanced cancer, including mPDAC,” said Daniel Schmitt, President & Chief Executive Officer of Actuate. 

He also commented, “Additionally, our recently reported interim Phase 2 data of elraglusib in combination with gemcitabine/nab-paclitaxel (GnP) also in the first-line treatment of mPDAC showed statistically significant improvements in 1-year and median overall survival, highlighting the potential of combining elraglusib with several different 1st line chemotherapy modalities in the treatment of mPDAC. We look forward to continuing both trials and further advancing our understanding of elraglusib’s therapeutic impact on mPDAC.” 

A total of 56 treatment-naïve mPDAC patients have been enrolled in this open-label, non-comparator Phase 2 trial (NCT05077800). The primary goals of the study are to assess the safety, tolerability, and progression-free survival of the combined treatment regimen. This milestone marks a key step in advancing Actuate’s efforts to develop novel therapies targeting glycogen synthase kinase-3 beta (GSK-3β) in difficult-to-treat cancers.

Colin Weekes, MD, Ph.D., Director of Medical Oncology Research for Pancreatic Cancer, Massachusetts General Hospital, and the study’s Principal Investigator stated, “We are happy to complete patient enrollment in this important trial, which represents a significant milestone in our efforts to improve the treatment of metastatic pancreatic cancer. Our team is optimistic that the insights gained from this trial will drive meaningful progress in developing more effective treatment options for patients. We look forward to reporting final results from the trial in 2026.”