Phase 1b Study of Oral HQP1351 for Treating Resistant Chronic Myeloid Leukemia and Philadelphia Positive Acute Lymphoblastic Leukemia

What this Trial Is About

Researchers are studying the drug HQP1351 in people with chronic myeloid leukemia CML in various stages and Philadelphia chromosome-positive acute lymphoblastic leukemia Ph ALL who have not responded well or cannot tolerate at least two other similar treatments called tyrosine kinase inhibitors TKIs. This phase Ib study aims to understand how HQP1351 behaves in the body and to find the best dose for future studies. It also includes patients with specific genetic mutations and forms of leukemia who have limited treatment options. Participants will be randomly assigned to one of three groups receiving different doses of HQP1351 taken by mouth every other day for 28 days in a cycle. Another group will receive HQP1351 combined with blinatumomab, an intravenous drug given in repeated 42-day cycles, to evaluate this combination in certain leukemia types. The study monitors dose-limiting toxicities in the first cycle to decide if a dose should continue. Blood samples will be collected to analyze drug levels and effects. During the trial, patients will undergo regular safety and efficacy assessments including blood tests and heart function checks. The main outcomes measured are the maximum concentration of HQP1351 in the blood and the overall exposure over 28 days. Patients must be able to follow the study procedures and will be monitored closely throughout treatment. The trial will continue until March 2030, offering ongoing evaluation of HQP1351s safety and pharmacokinetics in this patient population.

Study of HQP1351 in Subjects With Refractory CML and Ph+ ALL