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Blinatumomab

Ascentage Pharma HQP1351 bioavailable inhibitor

Administered in all patients as a continuous IV infusion at the dosage of 28μg daily (9μg daily for Cycle 1 Day 1 to Day 7).

Bill Garrett

Sarah Weaver

Omer Jamy, MD

London Hall

Thad Beck, MD

Paul Koller, MD

Shannon Gleason

Anthony Hunter, MD

Amelia Barkman

Maria Baer, MD

Erik Lewerenz

Sudipto Mukherjee, MD

Jovitta Jacob

Elias Jabbour, MD

Kaysey Orlowski

Vivian Oehler, MD

Yifan Zhai, MD, PhD

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.

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.

A total of 40 patients will be randomized at 3:3:2 ratio into one of the three dose cohorts (Cohorts 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.

For Cohort D: 14 to 22 Ph+ BCP ALL or CML LBP patients will be enrolled.

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

A Phase Ib Study of the Pharmacokinetics, Safety and Efficacy of Orally Administered HQP1351 in Subjects With Refractory Chronic Myeloid Leukemia (CML) and Ph+ Acute Lymphoblastic Leukemia (Ph+ ALL)

To evaluate the Maximum Plasma Concentration (Cmax) of HQP1351

To evaluate the Area Under the Curve (AUC) of HQP1351

Ascentage Pharma Group Inc.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Study of HQP1351 in Subjects With Refractory CML and Ph+ ALL	NCT04260022	Leukemia, Myelo... Myeloid Leukemi... Chronic Myeloid... Philadelphia Po... B Cell Precurso...	Ascentage Pharm... Blinatumomab	18 Years -	Ascentage Pharma Group Inc.
Study of HQP1351 in Subjects With Refractory CML and Ph+ ALL	NCT04260022	Leukemia, Myelo... Myeloid Leukemi... Chronic Myeloid... Philadelphia Po... B Cell Precurso...	Ascentage Pharm... Blinatumomab	18 Years -	Ascentage Pharma Group Inc.

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