POLARIS-2
Research type
Research Study
Full title
A GLOBAL MULTICENTER, OPEN LABEL, RANDOMIZED, PHASE 3 REGISTRATIONAL STUDY OF OLVEREMBATINIB (HQP1351) IN PATIENTS WITH CHRONIC PHASE CHRONIC MYELOID LEUKAEMIA (POLARIS-2)
IRAS ID
1010703
Contact name
Yifan Zhai
Contact email
Sponsor organisation
Ascentage Pharma Group Inc.
Eudract number
2024-511495-32
ISRCTN Number
NA
Clinicaltrials.gov Identifier
Research summary
This study is testing an investigational drug called Olverembatinib (also known as HQP 1351) (study drug) versus a control (Bosutinib). There are two parts to this study Part A & Part B.
In Part A of the study, patients are being invited to take part in this research study because they have Chronic Myeloid Leukemia-Chronic Phase (CML-CP) and have been previously treated with at least two tyrosine kinase inhibitors (TKIs). This research study is to compare the efficacy and safety of olverembatinib with that of bosutinib in the treatment of patients with CML-CP who had previously been exposed to a minimum of two TKIs.This study has part B in which patients are invited to take part in to test olverembatinib. Patients being invited to take part in Part B are invited because they have CML-CP with T315I mutation and previously treated with at least 1 prior TKI.
OLVEREMBATINIB also known as HQP 1351, is a new bioavailable TKI that is active against wild type as well as a broad spectrum of the BCR::ABL1 mutations, which can cause resistance to TKIs. 95% of subjects with Chronic Myeloid Leukemia (CML) have a conventionally identifiable chromosomal abnormality resulting in an abnormal fusion of BCR::ABL1 genes that results in uncontrolled growth and survival of cancer producing cells in the blood. This abnormal chromosome is also known as Philadelphia chromosome. Standard drugs targeting the BCR::ABL1 activity belong to the class of drugs called Tyrosine kinase inhibitors (TKIs) . However, mutations (changes in DNA) in the BCR::ABL1 region can make these standard drugs ineffective.
Olverembatinib has been developed to have a broad spectrum of activity against mutated forms of BCR::ABL1 gene. Therefore, this drug could potentially overcome the pitfalls of the standard drugs and be a possible new treatment for certain subjects with CML.
Length of participation depends on how well patients tolerate the study drug or if cancer doesn’t stabilise or improve.
REC name
Yorkshire & The Humber - Leeds West Research Ethics Committee
REC reference
25/YH/0010
Date of REC Opinion
5 Mar 2025
REC opinion
Further Information Favourable Opinion