Recruiting
Phase 3

Olverembatinib

Sponsor:

Ascentage Pharma Group Inc.

Code:

NCT06423911

Conditions

Chronic Myeloid Leukemia

CML

CML, Chronic Phase

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

olverembatinib

Bosutinib

Study Details

Brief summary:

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

Conditions

Chronic Myeloid Leukemia

CML

CML, Chronic Phase

Study ID

NCT06423911

Start date

Feb 5, 2024

Status verified date

May, 2025

Completion date

Feb, 2026

Anticipated

Primary completion date

Dec, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

285 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

other: Part A, RCT, olverembatinib arm and bosutinib arm

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 TKIs

other: Part B, SAT, olverembatinib arm

To evaluate the efficacy and safety of olverembatinib in the CML-CP patients with T315I mutation previously

Interventions

olverembatinib

olverembatinib QOD

Bosutinib

Bosutnib QD

Primary outcome measure

  • MMR rate Part A [ Time Frame: 24 weeks ]
  • MMR rate Part B [ Time Frame: 24 weeks ]

Central Contacts and Locations

Locations

MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

More Information

Sponsor

Ascentage Pharma Group Inc.

Last update posted

Jun 3, 2025

Last verified

May, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Ascentage Pharma Group Inc. on 2025-06-03.