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

Active:	Yes
Cancer Type:	Leukemia	NCT ID:	NCT04260022
Trial Phases:	Phase I	Protocol IDs:	HQP1351CU101 (primary) NCI-2020-01100
Eligibility:	18 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	Ascentage Pharma Group Inc.
NCI Full Details:	http://clinicaltrials.gov/show/NCT04260022

Summary

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 chronic phase (CP), accelerated phase (AP), or blast phase (BP) or with Ph+ ALL, who have
experienced resistance or intolerance to at least two tyrosine kinase inhibitors (TKIs) or in
subjects with Ph+ B-cell precursor (BCP) ALL or lymphoid blast phase CML (CML LBP), who have
experienced resistance or intolerance to at least one second or later generation TKI.

Objectives

Approximately 40 patients will be randomized at 3:3:2 ratio into one of three HQP1351
monotherapy dose cohorts (Cohort A, B, and C): 30 mg every other day (QOD), 40 mg QOD, and 50
mg QOD, with 15, 15, and 10 patients in Cohort A, B, and C. 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 two TKIs, for
patients with T315I mutation, number of pretreated TKIs is not restricted. Patients will be
administered HQP1351 orally QOD during a period of 28 days (1 cycle).

Cohort D (HQP1351 + blinatumomab) will enroll patients with relapsed/refractory Ph+ BCP ALL
or CML-BP using a dose escalation and expansion design. Patients will be administered HQP1351
orally QOD at an assigned dose with blinatumomab at repeated 42-day cycles. The first cycle
of 42 days is considered as the DLT observation period. The initial dose of HQP1351 will be
30 mg QOD.

Treatment Sites in Georgia

Winship Cancer Institute of Emory University
1365 Clifton Road NE
Building C
Atlanta, GA 30322
404-778-5180
winshipcancer.emory.edu

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