Actively Recruiting
Study of HQP1351 in Subjects With Refractory CML and Ph+ ALL
Led by Ascentage Pharma Group Inc. · Updated on 2025-11-05
242
Participants Needed
9
Research Sites
533 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Study of HQP1351 in Subjects With Refractory CML and Ph+ ALL
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with chronic myeloid leukemia (any phase) or Philadelphia chromosome-positive acute lymphoblastic leukemia
- Resistance or intolerance to at least two tyrosine kinase inhibitors (TKIs); no TKI number restriction if T315I mutation present
- For Cohort D, resistant or intolerant to at least one second or later generation TKI
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
- Life expectancy of at least 3 months
- Adequate kidney function (creatinine < 2x upper limit of normal or GFR ≥ 30 mL/min)
- Serum albumin ≥ 3.0 g/dL
- Total bilirubin < 1.5x upper limit of normal
- AST and ALT < 3x upper limit of normal (or < 5x if liver involved with leukemia)
- Serum amylase and lipase ≤ 1.5x upper limit of normal
- Prothrombin time ≤ 1.5x upper limit of normal
- Heart function with left ventricular ejection fraction > 50%
- Normal corrected QT interval on ECG
- Negative pregnancy test for females of childbearing potential
- Agreement to use effective contraception during study
- Ability to comply with study procedures as judged by investigator
You will not qualify if you...
- Received TKI therapy within 5 half-lives or 7 days before first HQP1351 dose, or unresolved adverse events from other treatments
- Recent use of hydroxyurea, anagrelide, interferon, immunotherapy, cytarabine, radiotherapy, chemotherapy, or investigational therapy within specified timeframes
- Current treatment with medications that may interact with HQP1351
- Prior treatment with HQP1351
- Need for immunosuppressive therapy except short-term steroids
- Gastrointestinal disorders affecting drug absorption
- Uncontrolled cardiovascular disease or specific heart conditions including recent myocardial infarction, unstable angina, cerebrovascular events, heart failure, arrhythmias, thromboembolism, or recent cardiac surgery
- History of stem cell transplant with active graft-versus-host disease or recent immune suppression
- Chronic myeloid leukemia patients with complete cytogenetic response
- Significant bleeding disorders unrelated to CML or Ph+ ALL
- Major surgery within 4 weeks prior to study or not recovered from surgery effects
- Central nervous system involvement confirmed cytologically
- Other primary malignancy within 1 year except certain treated skin cancers
- Active infections including HIV, hepatitis B or C with detectable virus, or COVID-19 positive
- Poorly controlled diabetes (HbA1C > 7.5%)
- Known allergy to study drug components
- Pregnant or lactating
- Any conditions that may compromise safety or interfere with study evaluation as judged by investigator
AI-Screening
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Trial Site Locations
Total: 9 locations
1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
Actively Recruiting
2
City of Hope
Duarte, California, United States, 91010
Actively Recruiting
3
Winship Cancer Institute, Emory University
Atlanta, Georgia, United States, 30322
Actively Recruiting
4
Augusta Cancer Center
Augusta, Georgia, United States, 30912
Actively Recruiting
5
University of Maryland
Baltimore, Maryland, United States, 21201
Actively Recruiting
6
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Actively Recruiting
7
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
8
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98109
Actively Recruiting
9
Princess Margaret Cancer Centre
Toronto, Ontario, Canada, M5G 2M9
Actively Recruiting
Research Team
B
Bill Garrett
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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