NIPH Clinical Trials Search

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

Basic Information

Recruitment status	Recruiting
Health condition(s) or Problem(s) studied	CP-CML
Date of first enrollment	09/06/2026
Target sample size	333
Countries of recruitment	United States,Japan,Canada,Japan,Spain,Japan,India,Japan,Poland,Japan,Australia,Japan,Russia,Japan,Italy,Japan,United Kingdom,Japan,South Korea,Japan,Singapore,Japan,Belgium,Japan,France,Japan,Germany,Japan,Taiwan (China),Japan,Hong Kong (China),Japan,Turkey,Japan,Brazil,Japan,Mexico,Japan
Study type	Interventional
Intervention(s)	Part A Drug: olverembatinib olverembatinib QOD Drug: Bosutinib Bosutnib QD Part B Drug: olverembatinib olverembatinib QOD

Outcome(s)

Primary Outcome	MMR rate Part A: To compare the major molecular response (MMR) rate at 24 weeks of olverembatinib versus bosutinib MMR rate Part B: To evaluate the MMR rate by 24 weeks of olverembatinib in CML-CP patients with T315I mutation
Secondary Outcome

Key inclusion & exclusion criteria

Age minimum	>= 18age old
Age maximum	<= 99age old
Gender	Both
Include 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 4. Part B: T315I mutation at screening and previously treated with at least one approved TKI, with no other effective and/or tolerable therapies available 5. Eastern Cooperative Oncology Group (ECOG) performance status (PS) <= 2 6. Patients with adequate organ functions
Exclude 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.