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

Description

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

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Study Overview

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Study Details

Study overview

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

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

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

Condition
Chronic Myeloid Leukemia
Intervention / Treatment

-

Contacts and Locations

Houston

MD Anderson Cancer Center, Houston, Texas, United States, 77030

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • 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.

Ages Eligible for Study

18 Years to 99 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Ascentage Pharma Group Inc.,

Study Record Dates

2026-02