Study of HQP1351 in Subjects With Refractory CML and Ph+ ALL
Eligible age
18+ yrs
Accepts
All genders
Locations
7 states
Healthy volunteers
No
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About this study
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.
Sponsor: Ascentage Pharma Group Inc.
You may qualify if…
- ✓ 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 dasatinib, nilotinib, bosutinib and ponatinib, despite optimal supportive care
- ✓ For HQP1351 monotherapy only: Be previously treated with and developed resistance or intolerance to at least two TKIs including ponatinib, imatinib, dasatinib, nilotinib, bosutinib, and asciminib. For patients with a T315I mutation, number of pretreated TKIs is not restricted.
- ✓ 1. The definition of resistance to first-line TKI treatment refers to European Leukemia Net (ELN) recommendations. The definitions are the same for patients in CP, AP, BP, and Ph+ ALL, and apply also to second-line treatment, when first-line treatment was changed for intolerance. The patients must meet at least one criterion:
- ✓ 1. Three months after the initiation of therapy: non-complete hematologic response (CHR) and/or Ph+ \>95%
- ✓ 2. Six months after the initiation of therapy: BCR-ABL1\>10% and/or Ph+ \>35%
- ✓ 3. Twelve months after the initiation of therapy: BCR-ABL1\>1% and/or Ph+ \>0%
- ✓ 4. Then, and at any time after the initiation of therapy: Loss of CHR, or loss of complete cytogenetic response (CCyR), or confirmed loss of major molecular response (MMR) (In 2 consecutive tests, of which one with a BCR-ABL1 transcripts level ≥1%), mutations, clonal chromosome abnormalities in Ph+ cells (CCA/Ph+)
You may not qualify if…
- ✕ Received TKI therapy within 5 half-lives or 7 days prior to first dose of HQP1351, whichever is shorter, or any adverse events (AEs) (except alopecia and pigmentation) not recovered to CTCAE v5.0 grade 0-1 due to any other treatments
- ✕ Received other therapies as follows:
- ✕ 1. For CP and AP patients, received hydroxyurea or anagrelide within 24 hours prior to the first dose of HQP1351; or, interferon, immunotherapy or cytarabine within 14 days prior to the first dose of HQP1351; or, any other radiotherapy, cytotoxic chemotherapy or investigational therapy within 28 days prior to receiving the first dose of HQP1351
- ✕ 2. For BP patients, received chemotherapy within 7 days prior to the first dose of HQP1351
- ✕ 3. For Ph+ ALL patients, received corticosteroids within 24 hours before the first dose of HQP1351, or received chemotherapy within 7 days prior to the first dose of HQP1351
- ✕ 4. Patients who are currently receiving treatment with a medication that has the potential to interact with HQP1351
- ✕ 5. Patients who had been treated with HQP1351
- ✕ 6. Patients requiring immunosuppressive therapy other than short time of steroid
Where it's recruiting
Birmingham
Duarte
Atlanta · Augusta
Baltimore
Cleveland
Houston
Seattle
Source: ClinicalTrials.gov · NCT04260022 · last updated 2025-11-05