Leukemia, Myeloid, ChronicPhase 1NCT04260022
Study of HQP1351 in Subjects With Refractory CML and Ph+ ALL
A Phase 1 study testing Ascentage Pharma HQP1351 bioavailable inhibitor and Blinatumomab in people with Leukemia, Myeloid, Chronic and Myeloid Leukemia, run by Ascentage Pharma Group Inc. at 9 sites in 2 countries.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Leukemia, Myeloid, Chronic, Myeloid Leukemia, Chronic Myeloid Leukemia
- What is being tested?
- Ascentage Pharma HQP1351 bioavailable inhibitor and Blinatumomab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 242 participants
- Where
- 9 sitesin 2 countries
- Study dates
- 9 Jan 2020to 31 Mar 2030
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- The definition of resistance to first-line TKI treatment refers to European Leukemia Net (ELN) recommendations. The definitions are the same for patients in CP, AP, BP, and Ph+ ALL, and apply also to second-line treatment, when first-line treatment was changed for intolerance. The patients must meet at least one criterion:
- Three months after the initiation of therapy: non-complete hematologic response (CHR) and/or Ph+ >95%
- Six months after the initiation of therapy: BCR-ABL1>10% and/or Ph+ >35%
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- Twelve months after the initiation of therapy: BCR-ABL1>1% and/or Ph+ >0%
- Then, and at any time after the initiation of therapy: Loss of CHR, or loss of complete cytogenetic response (CCyR), or confirmed loss of major molecular response (MMR) (In 2 consecutive tests, of which one with a BCR-ABL1 transcripts level ≥1%), mutations, clonal chromosome abnormalities in Ph+ cells (CCA/Ph+)
- The definition of resistance to second-line TKI treatment
- For CML CP patients: the patients must meet at least one criterion as follows:
- i.) Three months after the initiation of therapy: No CHR or Ph+ >95% or new mutations
- ii.) Six months after the initiation of therapy: BCR-ABL1>10% and/or Ph+ >65% and/or new mutations
- iii.) Twelve months after the initiation of therapy: BCR-ABL1>1% and/or Ph+ >35% and/or new mutations
- iv.) Then, and at any time after the initiation of therapy: Loss of CHR or loss of CCyR, new mutations, confirmed loss of MMR (In 2 consecutive tests, of which one with a BCR-ABL1 transcripts level ≥1%), clonal chromosome abnormalities in Ph+ cells (CCA/Ph+)
- For CML AP patients: the patients must meet at least one criterion as follows:
- i.) Three months after the initiation of therapy: failure to achieve a major hematologic response (MaHR)
- ii.) At any time after the initiation of therapy, the loss of a MaHR, confirmed in at least 2 consecutive analyses separated by at least 4 weeks
- iii.) At any time after the initiation of therapy, the development of new BCR-ABL kinase domain mutations in the absence of a MaHR
- For CML BP and Ph+ ALL patients: the patients must meet at least one criterion as follows:
- One month after the initiation of therapy: failure to achieve a MaHR
- At any time after the initiation of therapy, the loss of a MaHR, confirmed in at least 2 consecutive analyses separated by at least 1 week
- At any time after the initiation of therapy, the development of new BCR-ABL kinase domain mutations in the absence of a MaHR
- Intolerance to TKIs is defined as:
- Non-hematological AEs: patients with grade 3 or 4 toxicity during TKIs treatment, or with persistent grade 2 toxicity, unresponsive to optimal management, including dose adjustments in the absence of a CCyR for CP patients or MaHR for AP/BP or Ph+ ALL patients
- Hematological AEs: patients with grade 3 or 4 toxicity during TKIs treatment, that is recurrent after unresponsive after optimal management, including dose adjustments in the absence of a CCyR for CP patients or MaHR for AP/BP or Ph+ ALL patients
- 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:
- Creatinine < 2 × upper limit of normal (ULN); or, creatinine > 2 × ULN, with 24h glomerular filtration rate (GFR) ≥ 30 mL/min (Cockcroft-Gault)
- Serum albumin ≥ 3.0 g/dL
- Total bilirubin < 1.5 × ULN
- Aspartate aminotransferase (AST [Serum glutamic oxaloacetic transaminase (SGOT)]) and alanine aminotransferase (ALT [serum glutamate-pyruvate transaminase (SGPT)]) < 3 × ULN for institution (<5×ULN if liver involvement with leukemia)
- Serum amylase and lipase ≤ 1.5 × ULN
- Prothrombin time (PT) ≤ 1.5 × ULN
- 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
Who cannot join
- 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:
- 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
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- Patients who had been treated with HQP1351
- Patients requiring immunosuppressive therapy other than short time of steroid
- 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:
- Any history of myocardial infarction (MI) within 6 months or unstable angina within 3 months
- Any history of cerebrovascular accident within 1 year, or transient ischemic attack (TIA) within 3 months
- Any history of peripheral vascular infarction, including visceral infarction within 6 months
- Congestive heart failure (CHF) (New York Heart Association [NYHA] class III or IV) within 6 months prior to enrollment, or left ventricular ejection fraction (LVEF) less than lower limit of normal, per local institutional standards, within 6 months prior to enrollment
- History of clinically significant (as determined by the treating physician) atrial arrhythmia or any history of ventricular arrhythmia
- Venous thromboembolism, including deep venous thrombosis or pulmonary embolism, within 3 months prior to enrollment. Patients who have experienced a venous thromboembolic event should only be eligible if the condition is well controlled with optimal intervention (as determined by the treating physician). Continued prophylactic anticoagulation is acceptable.
- Patients with revascularization procedures including cardiac bypass within the 6 months and stenting within the past 3 months should be excluded.
- 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
Trial locations and contacts
9 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
9 sites in 2 countries
United States8 sites, 8 recruiting
- Recruiting
Winship Cancer Institute, Emory University
Atlanta, Georgia, 30322
Shannon Gleason, 404-778-4334, shannon.gleason@emory.edu
Anthony Hunter, MD
- Recruiting
Augusta Cancer Center
Augusta, Georgia, 30912
Amanda Spires, 706-721-8991, amspires@augusta.edu
Jorge Cortes, MD
- Recruiting
University of Maryland
Baltimore, Maryland, 21201
Amelia Barkman, Amelia.Barkman@umm.edu
Maria Baer, MD
- Recruiting
University of Alabama at Birmingham
Birmingham, Alabama, 35294
Sarah Weaver, 205-975-8080, sarahweaver@uabmc.edu
Omer Jamy, MD
- Recruiting
Cleveland Clinic
Cleveland, Ohio, 44195
Erik Lewerenz, 216-442-2524, LEWEREE@ccf.org
Sudipto Mukherjee, MD
- Recruiting
City of Hope
Duarte, California, 91010
Paul Koller, MD
- Recruiting
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
Jovitta Jacob, 713-745-6834, jojacob@mdanderson.org
Elias Jabbour, MD
- Recruiting
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109
Kaysey Orlowski, 206-667-1997, korlowsk@fredhutch.org
Vivian Oehler, MD
Canada1 site, 1 recruiting
- Recruiting
Princess Margaret Cancer Centre
Toronto, Ontario, M5G 2M9
Fatima Sheikh, Fatima.sheikh@uhn.ca
Dennis Kim, MD
About this study
Official 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)
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.
Read the detailed 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.
- Conditions
- Leukemia, Myeloid, Chronic, Myeloid Leukemia, Chronic Myeloid Leukemia, Philadelphia Positive Acute Lymphoblastic Leukemia, B Cell Precursor Type Acute Leukemia
- Being tested
- Ascentage Pharma HQP1351 bioavailable inhibitor, Blinatumomab
- Keywords
- T315I mutation, Chronic Phase, Accelerated Phase, Blast Phase, Lymphoid blast phase
- Medical subject headings
- Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Leukemia, Myeloid, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Burkitt Lymphoma, Blast Crisis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ascentage Pharma HQP1351 bioavailable inhibitorDrug
HQP1351 taken by mouth every other day
BlinatumomabDrug
Also called Blincyto
Administered in all patients as a continuous IV infusion at the dosage of 28μg daily (9μg daily for Cycle 1 Day 1 to Day 7).
| Study group | Role | What they receive |
|---|---|---|
| Cohort A | Experimental | Not described Receives: Drug: Ascentage Pharma HQP1351 bioavailable inhibitor |
| Cohort B | Experimental | Not described Receives: Drug: Ascentage Pharma HQP1351 bioavailable inhibitor |
| Cohort C | Experimental | Not described Receives: Drug: Ascentage Pharma HQP1351 bioavailable inhibitor |
| Cohort D | Experimental | Not described Receives: Drug: Ascentage Pharma HQP1351 bioavailable inhibitor; Drug: Blinatumomab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Plasma Concentration (Cmax) of HQP1351
To evaluate the Maximum Plasma Concentration (Cmax) of HQP1351
Measured: 28 days
Area Under the Curve (AUC) of HQP1351
To evaluate the Area Under the Curve (AUC) of HQP1351
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2020
- Study start9 Jan 2020
- Primary completion27 Dec 2029 (estimated)
- Study completion31 Mar 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Leukemia, Myeloid, ChronicStudies of the same condition, open and under way.
- More trials run by Ascentage Pharma Group Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A total of 40 patients will be randomized at 3:3:2 ratio into one of the three dose cohorts (Cohorts 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. For Cohort D: 14 to 22 Ph+ BCP ALL or CML LBP patients will be enrolled.
- Masking
- None (open label)
- Enrolment
- 242 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ascentage Pharma Group Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yifan Zhai, MD, PhD, Study chair, Ascentage Pharma Group Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04260022
- Sponsor's protocol ID
- HQP1351CU101
- Status last verified
- Nov 2025
- First submitted
- 18 Sep 2019
- Last updated
- 5 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jabbour E, Oehler VG, Koller PB, Jamy O, Lomaia E, Hunter AM, Uspenskaya O, Samarina S, Mukherjee S, Cortes JE, Baer MR, Zherebtsova V, Shuvaev V, Turkina A, Davydkin I, Guo H, Chen Z, Fu T, Jiang L, Wang C, Wang H, Yang D, Zhai Y, Kantarjian H. Olverembatinib After Failure of Tyrosine Kinase Inhibitors, Including Ponatinib or Asciminib: A Phase 1b Randomized Clinical Trial. JAMA Oncol. 2025 Jan 1;11(1):28-35. doi: 10.1001/jamaoncol.2024.5157.
PubMed 39570620Jiang Q, Li Z, Qin Y, Li W, Xu N, Liu B, Zhang Y, Meng L, Zhu H, Du X, Chen S, Liang Y, Hu Y, Liu X, Song Y, Men L, Chen Z, Niu Q, Wang H, Lu M, Yang D, Zhai Y, Huang X. 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. J Hematol Oncol. 2022 Aug 18;15(1):113. doi: 10.1186/s13045-022-01334-z.
PubMed 35982483
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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)
- ClinicalTrials.gov ID
- NCT04260022
- Acronym / sponsor ID
- HQP1351CU101
- Conditions
- Leukemia, Myeloid, Chronic, Myeloid Leukemia, Chronic Myeloid Leukemia, Philadelphia Positive Acute Lymphoblastic Leukemia, B Cell Precursor Type Acute Leukemia
- Keywords
- T315I mutation, Chronic Phase, Accelerated Phase, Blast Phase, Lymphoid blast phase
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 242 participants (estimated)
- Lead sponsor
- Ascentage Pharma Group Inc.Industry (pharma, biotech, devices)
- Study start
- 9 Jan 2020 (actual)
- Primary completion
- 27 Dec 2029 (estimated)
- Study completion
- 31 Mar 2030 (estimated)
- First posted
- 7 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- A total of 40 patients will be randomized at 3:3:2 ratio into one of the three dose cohorts (Cohorts 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. For Cohort D: 14 to 22 Ph+ BCP ALL or CML LBP patients will be enrolled.
| Arm | Type | Receives |
|---|---|---|
| Cohort A | Experimental | Drug: Ascentage Pharma HQP1351 bioavailable inhibitor |
| Cohort B | Experimental | Drug: Ascentage Pharma HQP1351 bioavailable inhibitor |
| Cohort C | Experimental | Drug: Ascentage Pharma HQP1351 bioavailable inhibitor |
| Cohort D | Experimental | Drug: Ascentage Pharma HQP1351 bioavailable inhibitor, Drug: Blinatumomab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (39 listed)
- 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.
- i.) Three months after the initiation of therapy: No CHR or Ph+ >95% or new mutations
- ii.) Six months after the initiation of therapy: BCR-ABL1>10% and/or Ph+ >65% and/or new mutations
Key exclusion criteria (30 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ascentage Pharma HQP1351 bioavailable inhibitorHQP1351 taken by mouth every other day | Drug | Cohort A, Cohort B, Cohort C, Cohort D |
| BlinatumomabAlso: BlincytoAdministered in all patients as a continuous IV infusion at the dosage of 28μg daily (9μg daily for Cycle 1 Day 1 to Day 7). | Drug | Cohort D |
Primary outcome
Maximum Plasma Concentration (Cmax) of HQP1351
Time frame: 28 days
To evaluate the Maximum Plasma Concentration (Cmax) of HQP1351
Area Under the Curve (AUC) of HQP1351
Time frame: 28 days
To evaluate the Area Under the Curve (AUC) of HQP1351
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2025.
- Derived from this study: PubMed 39570620Jabbour E, Oehler VG, Koller PB, Jamy O, Lomaia E, Hunter AM, Uspenskaya O, Samarina S, Mukherjee S, Cortes JE, Baer MR, Zherebtsova V, Shuvaev V, Turkina A, Davydkin I, Guo H, Chen Z, Fu T, Jiang L, Wang C, Wang H, Yang D, Zhai Y, Kantarjian H. Olverembatinib After Failure of Tyrosine Kinase Inhibitors, Including Ponatinib or Asciminib: A Phase 1b Randomized Clinical Trial. JAMA Oncol. 2025 Jan 1;11(1):28-35. doi: 10.1001/jamaoncol.2024.5157.
- Derived from this study: PubMed 35982483Jiang Q, Li Z, Qin Y, Li W, Xu N, Liu B, Zhang Y, Meng L, Zhu H, Du X, Chen S, Liang Y, Hu Y, Liu X, Song Y, Men L, Chen Z, Niu Q, Wang H, Lu M, Yang D, Zhai Y, Huang X. 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. J Hematol Oncol. 2022 Aug 18;15(1):113. doi: 10.1186/s13045-022-01334-z.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yifan Zhai, MD, PhD study chair
Ascentage Pharma Group Inc.
9 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Ascentage Pharma HQP1351 bioavailable inhibitor and Blinatumomab in people with Leukemia, Myeloid, Chronic and Myeloid Leukemia, run by Ascentage Pharma Group Inc. at 9 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 39 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bill Garrett (301-520-3962, Bill.Garrett@ascentage.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Plasma Concentration (Cmax) of HQP1351 (time frame: 28 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04260022, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2025.