A multi-center, open-label, randomized, phase Ib study to evaluate the pharmacokinetics (PK) of HQP1351 and to determine the recommended phase 2 dose (RP2D) of HQP1351 in subjects with CML CP and AP, who have experienced resistance or intolerance to at least two tyrosine kinase inhibitors (TKIs) such as imatinib, nilotinib, dasatinib, bosutinib or ponatinib.
Name: Ascentage Pharma HQP1351 bioavailable inhibitor
Description: To evaluate the Maximum Plasma Concentration (Cmax) of HQP1351
Measure: Maximum Plasma Concentration (Cmax) of HQP1351 Time: 27 daysDescription: To evaluate the Area Under the Curve (AUC) of HQP1351
Measure: Area Under the Curve (AUC) of HQP1351 Time: 27 daysAllocation: Randomized
Single Group Assignment
There is one SNP
Inclusion Criteria: - Patients must have CML in chronic phase (CP) or accelerated phase (AP) of any phenotype, with or without T315I mutation - Be previously treated with and developed resistance or intolerance to at least two TKIs (such as imatinib, dasatinib, nilotinib, bosutinib or ponatinib) 1. --- T315I ---
- Known allergy to any components in the study drug - Pregnant or lactating - Patients who have any conditions or illness that, according to the opinions of the investigator or the medical monitor, would comprise patient safety or interfere with the evaluation of safety and efficacy to the study drug Inclusion Criteria: - Patients must have CML in chronic phase (CP) or accelerated phase (AP) of any phenotype, with or without T315I mutation - Be previously treated with and developed resistance or intolerance to at least two TKIs (such as imatinib, dasatinib, nilotinib, bosutinib or ponatinib) 1. --- T315I ---
The randomization will be stratified to 3 groups: T315I mutated CML-CP and CML-AP, T315I un-mutated CML-CP, and T315I unmutated CML-AP to ensure that the subgroups are represented across all dose cohorts. --- T315I ---
The randomization will be stratified to 3 groups: T315I mutated CML-CP and CML-AP, T315I un-mutated CML-CP, and T315I unmutated CML-AP to ensure that the subgroups are represented across all dose cohorts. --- T315I --- --- T315I ---
The randomization will be stratified to 3 groups: T315I mutated CML-CP and CML-AP, T315I un-mutated CML-CP, and T315I unmutated CML-AP to ensure that the subgroups are represented across all dose cohorts. --- T315I --- --- T315I --- --- T315I ---