HQP1351CU101 = Study of HQP1351 in subjects with refractory chronic myeloid leukemia and Ph+ acute lymphoblastic leukemia [USA]
Study title
HQP1351CU101 = Study of HQP1351 in subjects with refractory chronic myeloid leukemia and Ph+ ALL
Scientific title
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)
Type of study
Trial after therapy failure or intolerance
Phase
Current status
Recruiting
Other trial ID
ClinicalTrials.gov NCT04260022
What is the purpose of the study
This is a phase 1b study to evaluate the pharmacokinetics of HQP1351 and to determine the recommended dose for phase 2 in subjects with CML chronic phase (CP), accelerated phase (AP) or blast phase (BP) or with Ph+ ALL, who have developed resistance or intolerance to at least two prior tyrosin kinase inhibitors (TKIs) or in subjects with Ph+ B-cell precursor (BCP) ALL or lymphoid blast phase CML (LBP), who have experienced resistance or intolerance to at least one second or later generation TKI. The preliminary efficacy and safety of HQP1351 in these patients will be evaluated as well.
What will happen during the study
In this study, patients with CML in chronic phase, accelerated phase, or blast phase will receive HQP1351 at a dose of either 30 mg, 40 mg, or 50 mg by mouth every other day for 28 days. (Cohort A, B, and C)
Patients with CML in lymphoid blast phase will receive HQP1351 at an initial dose of 30 mg by mouth every other day with blinatumomab as a continuous intravenous infusion at repeated 42-day cycles. (Cohort D)
Key inclusion criteria
This study includes male or female patients who:
- are 18 years or older.
- have been diagnosed with with CML in chronic phase or accelerated phase or blast phase or with Philadelphia chromosome positive (Ph+) acute lymphoblastic leukemia (ALL), with or without T315I mutation.
- for Cohort A, B, and C: have been previously treated with and developed resistance or intolerance to at least two TKIs, including ponatinib, imatinib, dasatinib, nilotinib, bosutinib, and asciminib. For patients with a T315I mutation, the number of previously given TKIs is not restricted.
- for Cohort D: have been diagnosed with with Ph+ BCP ALL or CML LBP and are resistant or intolerant to at least one second or later generation TKI, such as dasatinib, nilotinib, bosutinib and ponatinib, despite optimal supportive care.
- have adequate end-organ function.
- have an Eastern Co-Operative Oncology Group (ECOG) status of 0, 1 or 2.
Further criteria may apply. Please discuss these with your doctor or study staff.
Key exclusion criteria
This study does not include patients who:
- have received TKI therapy within 5 half-lives or 7 days prior to the first dose of HQP1351, whichever is shorter,
- have experienced adverse events (except alopecia [hair loss] and pigmentation) ndue to any other treatments and have not recovered.
- have received other therapies as follows:
- For CP and AP patients, received hydroxyurea or anagrelide within 24 hours prior to the first dose of HQP1351; or, interferon, immunotherapy or cytarabine within 14 days prior to the first dose of HQP1351; or, any other radiotherapy, cytotoxic chemotherapy or investigational therapy within 28 days prior to receiving the first dose of HQP1351
- For BP patients, received chemotherapy within 7 days prior to the first dose of HQP1351
- For Ph+ ALL patients, received corticosteroids within 24 hours before the first dose of HQP1351, or received chemotherapy within 7 days prior to the first dose of HQP1351
- Patients who are currently receiving treatment with a medication that has the potential to interact with HQP1351
- Patients who had been treated with HQP1351
- Patients requiring immunosuppressive therapy other than short time of steroid.
Further criteria may apply. Please discuss these with your doctor or study staff.
Estimated primary completion date
Where can I find additional information
You can find a study description in the US register ClinicalTrials.gov. This is a database provided by the U. S. National Institutes of Health.
Study sponsor
Ascentage Pharma Group Inc.
Scientific lead / contact
Yifan Zhai, MD, PhD
Ascentage Pharma Group Inc.
Principal investigator
Study chair: Yifan Zhai, MD, PhD
Ascentage Pharma Group Inc.
Study centers / principal investigators
United States
Alabama
University of Alabama at Birmingham
Birmingham, Alabama, 35294
Principal Investigator: Omer Jamy, MD
Arkansas
Highlands Oncology
Rogers, Arkansas, 72758
Principal Investigator: Thad Beck, MD
California
City of Hope
Duarte, California, 91010
Principal Investigator: Paul Koller, MD
Georgia
Winship Cancer Institute, Emory University
Atlanta, Georgia, 30322
Principal Investigator: Anthony Hunter, MD
Maryland
University of Maryland
Baltimore, Maryland, 21201
Principal Investigator: Maria Baer, MD
Ohio
Cleveland Clinic
Cleveland, Ohio, 44195
Principal Investigator: Sudipto Mukherjee, MD
Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
Contact: Elias Jabbour, MD
Washington
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109
Principal Investigator: Vivian Oehler, MD