Study of HQP1351 for Refractory CML and Ph+ ALL
This study is testing HQP1351, a medication taken by mouth every other day, in people with certain types of leukemia, specifically chronic myeloid leukemia (CML) or Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL). These conditions must have become resistant or intolerant to other treatments called tyrosine kinase inhibitors (TKIs). The study aims to understand how HQP1351 is absorbed and processed by the body (pharmacokinetics) and to find the best dose for future studies. For some patients, another drug called Blinatumomab will also be given through an IV. The study will measure the levels of HQP1351 in your blood over 28 days to help determine the best dose.
- Study design
- This is an open-label, randomized study with approximately 40 participants. It is designed to evaluate different doses of HQP1351.
- What's involved
- You would take HQP1351 by mouth every other day for at least 28 days. Blood samples will be collected at specific times to measure drug levels.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary endpoints for HQP1351 levels are measured at 28 days. Further follow-up is not specified.
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NCT04260022
Study of HQP1351 in Subjects With Refractory CML and Ph+ ALL
Recruiting
PHASE1Ages 18+InterventionalTreatmentAscentage Pharma Group Inc.
~242 participants
Updated 2025-11-05 on ClinicalTrials.gov
What's tested:Ascentage Pharma HQP1351 bioavailable inhibitorBlinatumomab
At a glance
Recruiting sites
9 of 9 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Maximum Plasma Concentration (Cmax) of HQP1351
Measured over 28 days
+1 more outcome measured
Conditions
Where it's being run
9 sites across 8 statesGeorgia2
Alabama1
California1
Maryland1
Ohio1
Texas1
Washington1
Ontario1
Study leadership
- Yifan Zhai, MD, PhD · STUDY_CHAIR · Ascentage Pharma Group Inc.
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
For HQP1351 monotherapy, patients must have CML in any phase (CP, AP, or BP of any phenotype) or Ph+ ALL, with or without T315I mutation
For Cohort D, patients with Ph+ BCP ALL or CML LBP must be resistant or intolerant to at least one second or later generation TKI, such as dasatinib, nilotinib, bosutinib and ponatinib, despite optimal supportive care
For HQP1351 monotherapy only: Be 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, number of pretreated TKIs is not restricted.
Patients providing written informed consent before initiation of any study-related activities
Eastern Cooperative Oncology Group (ECOG) performance status ≤2
Minimum life expectancy of 3 months or more
Patients with adequate organ function as defined below:
Heart function: Left ventricular ejection fraction (LVEF) \> 50%
Normal QT interval corrected Fridericia (QTcF) interval on screening electrocardiogram (ECG) evaluation: male ≤450ms, female ≤470ms
For females of childbearing potential, a negative pregnancy test must be established before enrollment. And the eligible female and male patients with childbearing potential must agree to use an effective form of contraception with their sexual partners throughout participation in this study
Ability to comply with study procedures, in the Investigator's opinion
Exclusion
Received TKI therapy within 5 half-lives or 7 days prior to first dose of HQP1351, whichever is shorter, or any adverse events (AEs) (except alopecia and pigmentation) not recovered to CTCAE v5.0 grade 0-1 due to any other treatments
Received other therapies as follows:
Impairment of gastrointestinal (GI) function or GI disease that may significantly alter absorption of study drugs
Patients with cardiovascular diseases, including uncontrolled high blood pressure (HBP) (that is blood pressure \>140/90mmHg.); or, receiving drugs that can cause prolonged QT interval. Patients with well controlled HBP can be considered to be included. ("well controlled HBP" is defined as: HBP can be ≤ 140/90mmHg with antihypertensive treatment). Those requiring 3 or more antihypertensive medications should be discussed with the medical monitor.
Have clinically significant, uncontrolled, or active cardiovascular disease, specifically including, but not restricted to:
Have history of autologous or allogeneic stem cell transplant, or with active graft-versus-host disease (GVHD), or active immune suppression in recent 6 months prior to informed consent date or active immune suppression in recent 6 months prior to informed consent date
CML CP patients with CCyR
Patients who have a significant bleeding disorder unrelated to CML or Ph+ ALL
Patients who had a major surgery within 4 weeks prior to study entry or have not recovered from side effects of such surgery which the Investigator considers not appropriate for enrollment
Cytologically confirmed central nervous system (CNS) involvement (if asymptomatic, spinal fluid examination is not necessary prior to first treatment)
Patients with another primary malignancy within 1 year of study entry. Patients with nonmelanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resection and are considered disease-free at the time of study entry.
Have ongoing or active infection, including known history of immunodeficiency virus (HIV) or HIV antibody positive, hepatitis B virus (HBV) or HBsAg positive, hepatitis C virus (HCV). Patients who have positive HCV antibody must have an undetectable HCV viral load.
Patients with COVID-19 who now present with positive swab
Patients who have poorly controlled diabetes, defined as HbA1C values of \> 7.5%. Patients with pre-existing, well-controlled diabetes are not excluded.
Known allergy to any components in the study drug
Pregnant or lactating
Patients who have any conditions or illness that, according to the opinions of the investigator or the medical monitor, would comprise patient safety or interfere with the evaluation of safety and efficacy to the study drug
What this trial measures
- Maximum Plasma Concentration (Cmax) of HQP135128 days
To evaluate the Maximum Plasma Concentration (Cmax) of HQP1351
- Area Under the Curve (AUC) of HQP135128 days
To evaluate the Area Under the Curve (AUC) of HQP1351