Phase 1/2 trial of Debio 1562M, novel inhibitor of aberrant leukemic signaling.

This first-in-human, open-label study evaluates Debio 1562M administered intravenously every 3 weeks to determine safety, tolerability, and optimal dosing in patients with relapsed or refractory acute myeloid leukemia and myelodysplastic syndromes. The trial design includes a Phase 1 dose escalation/optimization arm followed by a Phase 2 expansion to assess antileukemic activity. The study is sponsored by Debiopharm International SA at leading US centers.