Olverembatinib After Failure of Tyrosine Kinase Inhibitors, Including Ponatinib or Asciminib: A Phase 1b Randomized Clinical Trial.
Elias Jabbour, Vivian G Oehler, Paul B Koller...
https://pubmed.ncbi.nlm.nih.gov/39570620Actively Recruiting
Phase 1
Age: 18Years +
All Genders
ID04260022
A Phase Ib Study of the Pharmacokinetics, Safety and Efficacy of Orally Administered HQP1351 in Subjects With Refractory Chronic Myeloid Leukemia and Ph+ Acute Lymphoblastic Leukemia
Led by Ascentage Pharma Group Inc. · Updated on 2025-11-05
242
Participants Needed
9
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the drug HQP1351 in people with chronic myeloid leukemia (CML) in various stages and Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) who have not responded well or cannot tolerate at least two other similar treatments called tyrosine kinase inhibitors (TKIs). This phase Ib study aims to understand how HQP1351 behaves in the body and to find the best dose for future studies. It also includes patients with specific genetic mutations and forms of leukemia who have limited treatment options. Participants will be randomly assigned to one of three groups receiving different doses of HQP1351 taken by mouth every other day for 28 days in a cycle. Another group will receive HQP1351 combined with blinatumomab, an intravenous drug given in repeated 42-day cycles, to evaluate this combination in certain leukemia types. The study monitors dose-limiting toxicities in the first cycle to decide if a dose should continue. Blood samples will be collected to analyze drug levels and effects. During the trial, patients will undergo regular safety and efficacy assessments including blood tests and heart function checks. The main outcomes measured are the maximum concentration of HQP1351 in the blood and the overall exposure over 28 days. Patients must be able to follow the study procedures and will be monitored closely throughout treatment. The trial will continue until March 2030, offering ongoing evaluation of HQP1351's safety and pharmacokinetics in this patient population.
CONDITIONS
Brief Title
Study of HQP1351 in Subjects With Refractory CML and Ph+ ALL
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Diagnosed with chronic myeloid leukemia (any phase) or Philadelphia chromosome-positive acute lymphoblastic leukemia
- For HQP1351 monotherapy: resistant or intolerant to at least two tyrosine kinase inhibitors (TKIs), no limit on TKIs for patients with T315I mutation
- For combination cohort: resistant or intolerant to at least one second or later generation TKI
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- Expected to live at least 3 months or longer
- Adequate organ function including kidney, liver, and heart as defined in study
- Normal corrected QT interval on ECG and left ventricular ejection fraction above 50%
- Negative pregnancy test for females of childbearing potential and agreement to use contraception
- Ability to follow study procedures as assessed by investigator
You will not qualify if you...
- Recent tyrosine kinase inhibitor therapy within 5 half-lives or 7 days prior to study start
- Recent use of certain other therapies like chemotherapy, immunotherapy, or radiotherapy within specified timeframes before first dose
- Current use of medications that may interact with HQP1351
- Previous treatment with HQP1351
- Need for ongoing immunosuppressive therapy beyond short-term steroids
- Significant gastrointestinal disorders affecting drug absorption
- Uncontrolled or significant cardiovascular diseases including recent heart attack, stroke, heart failure, or arrhythmias
- History of stem cell transplant or active graft-versus-host disease within past 6 months
- Chronic myeloid leukemia patients with complete cytogenetic response
- Significant bleeding disorders or recent major surgery
- Central nervous system involvement by leukemia
- Other active malignancies within 1 year except certain skin cancers
- Active infections including HIV, hepatitis B or C, or COVID-19
- Poorly controlled diabetes with HbA1C over 7.5%
- Known allergies to study drug components
- Pregnant or breastfeeding
- Any condition deemed unsafe or interfering with study by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 28 days for HQP1351 monotherapy cohorts; repeated 42-day cycles for combination cohort
Participants receive HQP1351 orally every other day, with some participants also receiving blinatumomab as a continuous IV infusion depending on cohort assignment.
Repeated visits depending on cycle length and cohort assignment
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
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Research Team
B
Bill Garrett
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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Published Research Related To This Trial
Olverembatinib (HQP1351), a well-tolerated and effective tyrosine kinase inhibitor for patients with T315I-mutated chronic myeloid leukemia: results of an open-label, multicenter phase 1/2 trial.
Qian Jiang, Zongru Li, Yazhen Qin...
https://pubmed.ncbi.nlm.nih.gov/35982483