US clinical-stage biopharmaceutical company Actuate Therapeutics Inc (NASDAQ:ACTU) on Wednesday announced plans to initiate a Phase 1/2 clinical program evaluating its oral elraglusib tablet in patients with advanced cancers.

The Phase 1 portion, expected to start in the second half of 2026, will determine the maximum tolerated or administered dose, dose-limiting toxicities, pharmacokinetics, and preliminary anti-tumor activity.

Following Phase 1, the recommended dose for expansion will advance into Phase 2 for patients with refractory metastatic melanoma and other target solid tumor and hematologic cancers. The program builds on prior clinical data showing monotherapy activity in immune checkpoint inhibitor (CPI)-refractory metastatic melanoma, including disease control lasting 12 weeks or longer in half of treated patients and one complete response persisting over six years.

Refractory metastatic melanoma remains difficult to treat, with limited options after CPI therapy and historically low chemotherapy response rates of 4-10%. Elraglusib inhibits GSK3α and GSK3β, which may restore sensitivity to BRAF/MEK inhibitors or immune checkpoint inhibitors. The Phase 1/2 program will also explore additional hematologic malignancies where GSK3β inhibition could provide clinical benefit.