HQP1351CU101 = Study of HQP1351 in subjects with refractory chronic myeloid leukemia and Ph+ acute lymphoblastic leukemia [USA]

Study title

HQP1351CU101 = Study of HQP1351 in subjects with refractory chronic myeloid leukemia

Scientific title

A Phase Ib Study of the Pharmacokinetics, Safety and Efficacy of Orally Administered HQP1351 in Subjects With Refractory Chronic Myeloid Leukemia (CML) and Ph+ Acute Lymphoblastic Leukemia (Ph+ ALL) (ClinicalTrials.gov NCT04260022)

Indication and most important inclusion criteria

This study includes male or female patients 18 years and older with CML in chronic phase (CP) or accelerated phase (AP) or blast phase (BP) or with Ph+ ALL, with or without T315I mutation.

Eligible patients will be previously treated with and developed resistance or intolerance to at least three tyrosine kinase inhibitors (TKIs), including ponatinib, imatinib, dasatinib, nilotinib, or bosutinib. For patients with a T315I mutation, resistance or intolerance to ponatinib alone is acceptable.

To be considered for inclusion, patients must have adequate end-organ function, and an Eastern Co-Operative Oncology Group (ECOG) status of 0, 1 or 2.

Additional criteria may apply.

Short description of intervention

This is a phase 1b study to evaluate the pharmacokinetics of HQP1351 and to determine the recommended dose for phase 2 in subjects with CML CP, AP or BP or with Ph+ ALL, who have developed resistance or intolerance to at least three prior TKIs. The preliminary efficacy and safety of HQP1351 in these patients will be evaluated as well.

In this study, patients will receive HQP1351 at a dose of either 30 mg, 40 mg or 50 mg every other day for 28 days.

Type of study

Trial after therapy failure or intolerance

Current status

Recruiting

Study sponsor

Ascentage Pharma Group Inc.

Scientific lead / contact

Yifan Zhai, MD, PhD
Ascentage Pharma Group Inc.

Principal investigator

Study chair: Yifan Zhai, MD, PhD
Ascentage Pharma Group Inc.

Additional information

Study description in the US register ClinicalTrials.gov, a service of the U. S. National Institutes of Health 

Study centers / principal investigators

United States

Arkansas

Highlands Oncology
Rogers, Arkansas, 72758
Principal Investigator: Thad Beck, MD

Georgia

Winship Cancer Institute, Emory University
Atlanta, Georgia, 30322
Principal Investigator: Rebecca Klisovic, MD

Ohio

Cleveland Clinic
Cleveland, Ohio, 44195
Principal Investigator: Sudipto Mukherjee, MD

Texas

University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
Contact: Elias Jabbour, MD

Washington

Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109
Principal Investigator: Vivian Oehler, MD



 
   
 

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