Clinical Trials Logo

Clinical Trial 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.


Clinical Trial Description

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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04260022
Study type Interventional
Source Ascentage Pharma Group Inc.
Contact Bill Garrett
Phone 301-520-3962
Email Bill.Garrett@ascentage.com
Status Recruiting
Phase Phase 1
Start date January 9, 2020
Completion date January 31, 2024

See also
  Status Clinical Trial Phase
Recruiting NCT05400122 - Natural Killer (NK) Cells in Combination With Interleukin-2 (IL-2) and Transforming Growth Factor Beta (TGFbeta) Receptor I Inhibitor Vactosertib in Cancer Phase 1
Completed NCT02057185 - Occupational Status and Hematological Disease
Recruiting NCT03326310 - Selumetinib and Azacitidine in High Risk Chronic Blood Cancers Phase 1
Recruiting NCT04621851 - Retro-prospective Observational Study on Risk of Progression in CP-CML Patients Eligible for TKI Discontinuation
Completed NCT01207440 - Ponatinib for Chronic Myeloid Leukemia (CML) Evaluation and Ph+ Acute Lymphoblastic Leukemia (ALL) Phase 2
Not yet recruiting NCT06409936 - PEARL Study: PotEntial of Asciminib in the eaRly Treatment of CML Phase 2
Active, not recruiting NCT02917720 - 2nd or 3rd TKI-stop After 2 Years Nilotinib Pre-treatment in CML-patients Phase 2
Not yet recruiting NCT02883036 - Vitro Study of Tigecycline to Treat Chronic Myeloid Leukemia N/A
Withdrawn NCT01188889 - RAD001 in Patients With Chronic Phase Chronic Myeloid Leukemia w/ Molecular Disease. Phase 1/Phase 2
Completed NCT01795716 - Bioequivalence Study of Mesylate Imatinib Capsule in Chronic Myeloid Leukemia Body Phase 1
Completed NCT00988013 - Intensity Modulated Total Marrow Irradiation (IM-TMI) for Advanced Hematologic Malignancies N/A
Approved for marketing NCT00905593 - Nilotinib in Adult Patients With Imatinib-resistant or Intolerant Chronic Myeloid Leukemia in Blast Crisis, Accelerated Phase or Chronic Phase Phase 3
Terminated NCT00573378 - Imatinib or Nilotinib With Pegylated Interferon-α2b in Chronic Myeloid Leukemia Phase 2
Terminated NCT00522990 - Study to Assess the Safety of Escalating Doses of AT9283, in Patients With Leukemias Phase 1/Phase 2
Completed NCT00469014 - Busulfan, Fludarabine, Clofarabine With Allogeneic Stem Cell Transplantation for Acute Myeloid Leukemia Phase 2
Completed NCT00257647 - Use of SV40 Vectors to Treat Chronic Myeloid Leukemia (CML) N/A
Unknown status NCT00598624 - Clinical Trial to Evaluate the Safety and Efficacy of Treosulfan Based Conditioning Prior to Allogeneic Haematopoietic Stem Cell Transplantation (HSCT) Phase 2
Completed NCT00219739 - STI571 ProspectIve RandomIzed Trial: SPIRIT Phase 3
Completed NCT06148493 - Real-World Usage of Asciminib Among Patients With Chronic Myeloid Leukemia in Chronic Phase in the United States Using a Large Claims Database
Completed NCT00375219 - Homoharringtonine (Omacetaxine Mepesuccinate) in Treating Patients With Chronic Myeloid Leukemia (CML) With the T315I BCR-ABL Gene Mutation Phase 2