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

A multi-center, open-label, randomized, phase Ib study to evaluate the pharmacokinetics (PK) of HQP1351 and to determine the recommended phase 2 dose (RP2D) of HQP1351 in subjects with CML chronic phase (CP), accelerated phase (AP), or blast phase (BP) or with Ph+ ALL, who have experienced resistance or intolerance to at least two tyrosine kinase inhibitors (TKIs) or in subjects with Ph+ B-cell precursor (BCP) ALL or lymphoid blast phase CML (CML LBP), who have experienced resistance or intolerance to at least one second or later generation TKI.

NCT Number	NCT04260022
Lead Sponsor	Ascentage Pharma Group Inc.
Conditions	Leukemia, Myeloid, Chronic, Myeloid Leukemia, Chronic Myeloid Leukemia, Philadelphia Positive Acute Lymphoblastic Leukemia, B Cell Precursor Type Acute Leukemia
Enrollment	242 participants
Start Date	2020-01-09
Primary Completion	2029-12-27 (estimated)
Study Completion	2030-03-31 (estimated)
Updated on ClinicalTrials.gov	2025-11-05