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Study of Olverembatinib (HQP1351) in Patients With CML-CP
Trial Status: active
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.
Inclusion Criteria
Inclusion Criteria
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
Exclusion Criteria
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
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT06423911.
