Actuate Therapeutics (NASDAQ: ACTU) has announced results from the phase 1 portion of its Actuate-1902 Phase 1/2 clinical study evaluating elraglusib as a monotherapy or in combination with irinotecan, irinotecan plus temozolomide, or with cyclophosphamide plus topotecan in pediatric patients with refractory malignancies.
According to Actuate, data from the Phase 1 trial showed clinical responses in relapsed/refractory Ewing sarcoma (EWS), which is viewed as positive evidence of clinical activity in this difficult-to-treat indication.
In a statement, Daniel Schmitt, president and CEO of Actuate, commented, “Elraglusib continues to exhibit the potential to extend and improve the lives of patients in disease settings where specific treatment options are extremely limited. In the 1902 trial, we observed early signals of significant efficacy in EWS, neuroblastoma and desmoplastic small round cell tumor (DSRCT), showing that elraglusib’s unique mechanism of action can play an important role in multiple difficult-to-treat cancers. We plan to initiate additional clinical trials in 2026 that expedite a registration pathway for the program in patients with Ewing sarcoma and potentially advancing elraglusib in neuroblastoma.”
