RecruitingChronic Myeloid LeukemiaCMLCML, Chronic Phase

Study of Olverembatinib (HQP1351) in Patients With CML-CP

Eligible age

18+ yrs

Accepts

All genders

Locations

25 states

Healthy volunteers

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About this study

Study comparing efficacy and safety of olverembatinib (investigational arm) vs. bosutinib (control arm) in patients with CML-CP (Part A). Study will also evaluate efficacy and safety of olverembatinib (single-arm) in CML-CP patients with T315I mutation (Part B). Patients who meet ELN 2025 failure criteria while receiving bosutinib in Part A may be able to receive olverembatinib in crossover follow-on study.

Sponsor: Ascentage Pharma Group Inc.

You may qualify if…

✓ Patients eligible for inclusion in this study must meet all of the following criteria:
✓ 1. Age ≥ 18 years old
✓ 2. Diagnosis of CML-CP
✓ 3. Part A: Previously treated with at least two approved TKIs; Part B: T315I mutation at screening and previously treated with at least one approved TKI, with no other effective and/or tolerable therapies available
✓ 4. Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 2
✓ 5. Patient has adequate organ function

You may not qualify if…

✕ Patients eligible for this study must not meet any of the following criteria:
✕ 1. For Part A only: T315I or V299L mutation at any time prior to starting study treatment
✕ 2. Active infection that requires systemic drug therapy
✕ 3. Impairment of gastrointestinal (GI) function or GI disease that may significantly alter absorption of study drugs
✕ 4. Previous treatment with or known / suspected hypersensitivity to olverembatinib or any of its excipients
✕ 5. Previous treatment with or known / suspected hypersensitivity to bosutinib or any of its excipients
✕ 6. Pregnant or nursing (lactating) women