drugset / Trial / NCT06423911

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

NCT06423911 ↗

Phase 3 Recruiting 333 enrolled Ascentage Pharma Group Inc.
RandomizedParallel-groupOpen-labelTreatment

Summary

Study comparing efficacy and safety of olverembatinib (investigational arm) vs. bosutinib (control arm) in patients with CML-CP (Part A). Study will also evaluate efficacy and safety of olverembatinib (single-arm) in CML-CP patients with T315I mutation (Part B). Patients who meet ELN 2025 failure criteria while receiving bosutinib in Part A may be able to receive olverembatinib in crossover follow-on study.

Timeline

Start
2024-02-05
Primary completion
2027-06-30
Completion
2028-07-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Bosutinib Small molecule — —
Subject Olverembatinib Small molecule — —