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Study of Olverembatinib (HQP1351) in Patients With CP-CML | Clinical Trials | Clareo Health

RECRUITINGPHASE3

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

This is a Global, Multi-center, Open-label Randomized and Registrational Phase 3 Study of Olverembatinib (HQP1351) in Patients With Chronic Phase Chronic Myeloid Leukemia

NCT06423911•Ascentage Pharma Group Inc.

View on ClinicalTrials.gov

Summary

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

Detailed Description

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.

Eligibility

Age

18 - 99 years

Sex

ALL

Healthy Volunteers

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

Exclusion Criteria

•Patients eligible for this study must not meet any of the following criteria.
•1. For Part A only: T315I 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.

Locations (1)

MD Anderson Cancer Center

Houston, Texas, United States

Key Dates

Start Date

February 5, 2024

Primary Completion Date

December 1, 2025

Completion Date

February 1, 2026

Last Updated

June 3, 2025

Enrollment

285

ESTIMATED participants

Conditions

Chronic Myeloid LeukemiaCMLCML, Chronic Phase

Interventions

olverembatinib

DRUG

Bosutinib

DRUG

Contacts

Kate Shantz

CONTACT

301-509-0038 kate.shantz@ascentage.com

Huanshan Guo

CONTACT

huanshan.guo@ascentage.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 3, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

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