US clinical-stage biopharmaceutical company Actuate Therapeutics Inc (NASDAQ: ACTU) on Thursday announced the completion of its Phase 1 clinical trial evaluating elraglusib in paediatric patients with relapsed or refractory malignancies, including Ewing Sarcoma.

The study demonstrated prolonged and durable complete responses in two of ten patients with treatment-resistant Ewing Sarcoma, a highly aggressive cancer of the bone and surrounding soft tissues that is most often found in teenagers.

Two additional Ewing Sarcoma patients achieved durable stable disease, while a partial response was observed in one patient with a desmoplastic small-round-cell tumour. All patients received elraglusib in combination with topotecan and cyclophosphamide.

These results have prompted Actuate to initiate planning for a Phase 2 clinical trial targeting paediatric, adolescent, and adult patients with relapsed or refractory Ewing Sarcoma. The company is working with regulatory agencies and expert groups to align the trial design with clinical and patient needs.

Ewing Sarcoma is a highly metastatic cancer with limited treatment options and poor survival outcomes, especially in relapsed or resistant cases. Elraglusib's observed activity in this population positions it as a potential first-in-class therapy.

The upcoming trial is expected to begin in 2026, contingent on funding availability.