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

NCT06423911 | Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: HQP1351CG301
• Study Type: interventional
• Target: 285
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• MMR rate Part A

  To compare the major molecular response (MMR) rate at 24 weeks of olverembatinib versus bosutinib

  24 weeks

• MMR rate Part B

  To evaluate the MMR rate by 24 weeks of olverembatinib in CML-CP patients with T315I mutation

  24 weeks

Study Arms (2)

Part A, RCT, olverembatinib arm and bosutinib arm

OTHER

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

Drug: olverembatinib; Drug: Bosutinib

Part B, SAT, olverembatinib arm

OTHER

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

Drug: olverembatinib

Interventions

olverembatinib DRUG

olverembatinib QOD

Part A, RCT, olverembatinib arm and bosutinib arm; Part B, SAT, olverembatinib arm

Bosutinib DRUG

Bosutnib QD

Part A, RCT, olverembatinib arm and bosutinib arm

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• Ascentage Pharma Group Inc.: lead

Study Sites (1)

MD Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

MeSH Terms

Conditions

Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Leukemia, Myeloid, Chronic-Phase

Interventions

olverembatinib; bosutinib

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Myeloproliferative Disorders; Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Kate Shantz

CONTACT

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

Huanshan Guo

CONTACT

huanshan.guo@ascentage.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Part A 2:1 ratio Part B: control

Study Record Dates

• First Submitted: May 16, 2024
• First Posted: May 21, 2024
• Study Start: February 5, 2024
• Primary Completion: December 1, 2025
• Study Completion: February 1, 2026
• Last Updated: June 3, 2025

Record last verified: 2025-05

Locations

US (1)