NCT06423911

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 285 (estimated)
• Sponsor: Ascentage Pharma Group Inc. · Industry
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Myeloid Leukemia
• CML
• CML, Chronic Phase

Interventions

Type	Name	Description
DRUG	olverembatinib	olverembatinib QOD
DRUG	Bosutinib	Bosutnib QD

Timeline

• Start date: 2024-02-05
• Primary completion: 2025-12-01
• Completion: 2026-02-01
• First posted: 2024-05-21
• Last updated: 2025-06-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study