Study of HQP1351 in Subjects With Refractory CML and Ph+ ALL

Summary

Participation Requirements

Description

This is a multi-center, open-label, randomized, phase Ib study to evaluate the PK of HQP1351 and to determine the RP2D of HQP1351 in subjects with CML CP, AP or BP or with Ph+ ALL, who have experienced resistance or intolerance to at least three TKIs. The preliminary efficacy and safety of HQP1351 i...

This is a multi-center, open-label, randomized, phase Ib study to evaluate the PK of HQP1351 and to determine the RP2D of HQP1351 in subjects with CML CP, AP or BP or with Ph+ ALL, who have experienced resistance or intolerance to at least three TKIs. The preliminary efficacy and safety of HQP1351 in these patients will be evaluated as well. A total of 30 patients will be randomized at 1:1:1 ratio into one of the three dose cohorts: 30 mg every other day (QOD), 40 mg QOD, and 50 mg QOD, with 10 patients per dose cohort. The first cycle of 28 days is considered as the dose-limiting toxicity (DLT) observation period. If the incidence of DLTs exceeds 20% (2 patients) in 50 mg dose cohort during the first cycle of therapy, this dose cohort will be stopped. The randomization will be stratified to 4 groups: T315I mutated CML-CP and CML-AP, T315I un-mutated CML-CP, T315I unmutated CML-AP, and CML-BP and Ph+ ALL to ensure that the subgroups are represented across all dose cohorts. Blood samples will be collected from each subject at specified time points to evaluate the PK of HQP1351. RP2D of HQP1351 will be determined based on the comprehensive analyses of the PK, safety, and efficacy data of the US patients treated with HQP1351, when compared with that in the Chinese patients. Eligible patients will have disease resistance to or intolerance to at least three TKIs, for patients with T315I mutation, resistance or intolerance to ponatinib alone is acceptable. Patients will be administered HQP1351 orally every other day (QOD) during a period of 28 days (1 cycle).

Tracking Information