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.

Trial Details

NCT ID
NCT04260022
Phase
PHASE1
Sponsor
Ascentage Pharma Group Inc.
Status
RECRUITING
Cancer Type
Leukemia
Interventions
  • Ascentage Pharma HQP1351 bioavailable inhibitor
  • Blinatumomab
Locations (sample)
  • Birmingham, Alabama, United States|33.52066,-86.80249
  • Duarte, California, United States|34.13945,-117.97729
  • Atlanta, Georgia, United States|33.749,-84.38798
  • Augusta, Georgia, United States|33.47097,-81.97484
  • Baltimore, Maryland, United States|39.29038,-76.61219

Key Eligibility Criteria

  • For HQP1351 monotherapy, patients must have CML in any phase (CP, AP, or BP of any phenotype) or Ph+ ALL, with or without T315I mutation
  • For Cohort D, patients with Ph+ BCP ALL or CML LBP must be resistant or intolerant to at least one second or later generation TKI, such as dasatini…
  • For HQP1351 monotherapy only: Be previously treated with and developed resistance or intolerance to at least two TKIs including ponatinib, imatinib…
  • The definition of resistance to first-line TKI treatment refers to European Leukemia Net (ELN) recommendations. The definitions are the same for pa…

For full eligibility, visit ClinicalTrials.gov.

Check If You May Be Eligible

Trialify translates complex eligibility criteria into plain yes-or-no questions to help you understand if this trial might be right for you.

Find Leukemia Trials on Trialify →