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

About

Brief Summary

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.

Primary Purpose

Treatment

Study Type

Interventional

Phase

Phase 3

Eligibility

Gender

All

Healthy Volunteers

No

Minimum Age

18 Years

Maximum Age

N/A

Inclusion Criteria

Patients eligible for inclusion in this study must meet all of the following criteria:

Age ≥ 18 years old
Diagnosis of CML-CP
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
Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 2
Patient has adequate organ function

Exclusion Criteria

Patients eligible for this study must not meet any of the following criteria:

For Part A only: T315I or V299L mutation at any time prior to starting study treatment
Active infection that requires systemic drug therapy
Impairment of gastrointestinal (GI) function or GI disease that may significantly alter absorption of study drugs
Previous treatment with or known / suspected hypersensitivity to olverembatinib or any of its excipients
Previous treatment with or known / suspected hypersensitivity to bosutinib or any of its excipients
Pregnant or nursing (lactating) women

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