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

Recruiting now · Phase 3

Conditions studied: Chronic Myeloid Leukemia, CML, CML, Chronic Phase

In brief

A Global Multicenter, Open Label, Randomized, Phase 3 Registrational Study of Olverembatinib (HQP1351) in Patients with Chronic Phase Chronic Myeloid Leukemia (POLARIS-2)

Key facts

Study ID

NCT06423911

Run by

Ascentage Pharma Group Inc.

People needed

285

Starts

2024-02-05

Expected to finish

2026-02-01

Last updated by the study team

2025-06-03

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• MD Anderson Cancer Center — Houston, Texas, United States (enrolling)

Full record on ClinicalTrials.gov

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