Core Insights - Actuate Therapeutics plans to initiate a Phase 1/2 clinical program for elraglusib, an oral tablet formulation targeting advanced cancers, in the second half of 2026 [1][2] Group 1: Clinical Trial Details - The Phase 1 portion aims to determine the maximum tolerated dose (MTD) and assess dose-limiting toxicities (DLTs) of elraglusib tablets, while also investigating pharmacokinetics (PK) and preliminary anti-tumor activity [2] - The Phase 2 trial will focus on patients with refractory metastatic melanoma and other indications, building on previous encouraging results from a Phase 1 study where 5 out of 10 patients achieved disease control lasting 12 weeks or longer [2] - In the earlier Phase 1 study involving 67 patients, the median overall survival was reported at 9.9 months, with one patient achieving a complete response lasting over 6 years [2] Group 2: Drug Mechanism and Target Indications - Elraglusib targets glycogen synthase kinase-3 beta (GSK-3β), which is implicated in cancer progression, particularly in melanoma [3] - The drug may provide synergistic potential with existing therapies, such as BRAF and MEK inhibitors, and immune checkpoint inhibitors (ICIs) [3] - The company plans to include additional targeted histologies in the Phase 1/2 study, particularly select hematologic malignancies where GSK-3β inhibition has shown activity [4] Group 3: Company Overview - Actuate Therapeutics is a clinical-stage biopharmaceutical company focused on developing therapies for difficult-to-treat cancers [5] - The lead investigational drug, elraglusib, is a novel GSK-3β inhibitor that targets molecular pathways involved in tumor growth and resistance to conventional therapies [5][6]
Actuate Therapeutics Announces Plans to Expand Clinical Pipeline, Advancing Elraglusib Tablet into a Phase 1/2 Clinical Program in Refractory Cancers