POLARIS-2 = Study of Olverembatinib (HQP1351) in Patients With CP-CML [USA]
Study title
Study of Olverembatinib (HQP1351) in Patients with CP-CML
Scientific title
A Global Multicenter, Open Label, Randomized, Phase 3 Registrational Study of Olverembatinib (HQP1351) in Patients with Chronic Phase Chronic Myeloid Leukemia (POLARIS-2)
Type of study
Therapy optimization trial
Phase
Current status
Recruiting
Other trial ID
HQP1351CG301; ClinicalTrials.gov NCT06423911
What is the purpose of the study
This study is conducted to compare the efficacy and safety of olverembatinib (HQP1351) versus bosutinib in patients with chronic phase chronic myeloid leukemia (CP-CML) previously treated with at least two tyrosine kinase inhibitors (TKIs).
What will happen during the study
The study consists of two parts, A and B.
In Part A, patients with CML-CP previously treated with at least two TKIs will be randomly assigned to receive either olverembatinib (HQP1351) or bosutinib. The safety and efficacy of olverembatinib will be compared to bosutinib in terms of the major molecular response (MMR) rate at 24 weeks.
In Part B, patients with CML-CP with T315I mutation will receive olverembatinib (HQP1351). The safety and MMR rate at 24 weeks will be evaluated.
Key inclusion criteria
This study includes patients of all sexes who:
- are aged at least 18 years
- have been diagnosed with chronic myelogenous leukemia in chronic phase (CML-CP)
- Part A: have been previously treated with at least two approved TKIs
- Part B: have T315I mutation at screening.
- have an Eastern Co-Operative Oncology Group (ECOG) status of 0, 1 or 2
- have adequate organ functions
Further criteria apply. Please discuss these with your doctor or study staff.
Key exclusion criteria
This study does not include patients who:
- for Part A only: have T315I mutation at any time prior to starting study treatment
- have an active infection that requires systemic drug therapy
- have an impairment of gastrointestinal (GI) function or GI disease that may significantly alter absorption of study drugs
- have had previous treatment with or known / suspected hypersensitivity to olverembatinib or any of its excipients
- have had revious treatment with or known / suspected hypersensitivity to bosutinib or any of its excipients
- are pregnant or breast-feeding
Further criteria may apply. Please discuss these with your doctor or study staff.
Estimated primary completion date
Where can I find additional information
You can find a study description in the US registry ClinicalTrials.gov. This is a database provided by of the U. S. National Institutes of Health.
Study sponsor
Ascentage Pharma Group Inc.
Scientific lead / contact
Ben Little, Ascentage Pharma Group Inc.
Principal investigator
Study centers / principal investigators
United States
Texas
M D Anderson Cancer Center
Houston, Texas, 77030