A Phase 3 Registrational Study of Olverembatinib (HQP1351) in Patients With CML

Chronic Myeloid Leukemia Clinical Trial

— POLARIS-2  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06423911
• Other study ID #: HQP1351CG301
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: May 2024
• Est. completion date: February 2026

Study information

• Verified date: May 2024
• Source: Ascentage Pharma Group Inc.
• Contact: Ben Little
• Phone: 301-509-3222
• Email: ben.little[@]ascentage.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

This is a global, multi-center, open-label randomized and registrational phase 3 study of olverembatinib: Part A is a randomized controlled part that is designed to compare the efficacy and safety of olverembatinib (investigational arm) versus bosutinib (control arm) in patients with CML-CP, previously treated with at least two tyrosine kinase inhibitors (TKIs). Part B is to evaluate the efficacy and safety of olverembatinib in the CML- CP patients with T315I mutation.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 285
• Est. completion date: February 2026
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Myeloid Leukemia
• CML
• CML, Chronic Phase
• Leukemia
• Leukemia, Myelogenous, Chronic, BCR-ABL Positive
• Leukemia, Myeloid
• Leukemia, Myeloid, Chronic-Phase

Intervention

Drug:
• olverembatinib
olverembatinib QOD
• Bosutinib
Bosutnib QD

Locations

Country	Name	City	State
United States	MD Anderson Cancer Center	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Ascentage Pharma Group Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MMR rate Part A	To compare the major molecular response (MMR) rate at 24 weeks of olverembatinib versus bosutinib	24 weeks
Primary	MMR rate Part B	To evaluate the MMR rate by 24 weeks of olverembatinib in CML-CP patients with T315I mutation	24 weeks