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

The hypothesis suggests that in Part A, olverembatinib leads to a higher MMR rate compared to bosutinib in CP-CML patients without the T315I mutation; and in Part B, olverembatinib can provide therapeutic benefits to CP-CML patients with the T315I mutation.

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.
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 2.
• Written informed consent obtained prior to any screening procedures.
• Patients with adequate organ functions

Exclusion criteria

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

• For Part A only: T315I 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.