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Ascentage Pharma HQP1351 bioavailable inhibitor

Phase 1

Leukemia, Myeloid, Chronic | Small molecule | Oncology |Ascentage Pharma Group International - American Depository Shares|Last Updated: Nov 5, 2025

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment242

FDA Designations

No designations recorded

Clinical trial landscape

Ascentage Pharma HQP1351 bioavailable inhibitor · 1 trial · 5 indications

Phase 1 1
NCT04260022Study of HQP1351 in Subjects With Refractory CML and Ph+ ALLLeukemia, Myeloid, Chronic
RECRUITING242 Analytics
PHASE1RECRUITING
Study of HQP1351 in Subjects With Refractory CML and Ph+ ALL
Leukemia, Myeloid, ChronicUnlock trial analytics

Study Endpoints

Primary Endpoints

Maximum Plasma Concentration (Cmax) of HQP1351
28 days

To evaluate the Maximum Plasma Concentration (Cmax) of HQP1351

Area Under the Curve (AUC) of HQP1351
28 days

To evaluate the Area Under the Curve (AUC) of HQP1351

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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Cohort AEXPERIMENTAL -
Cohort BEXPERIMENTAL -
Cohort CEXPERIMENTAL -
Cohort DEXPERIMENTAL -

Interventions

NameTypeDescription
Ascentage Pharma HQP1351 bioavailable inhibitorDRUGHQP1351 taken by mouth every other day
BlinatumomabDRUGAdministered in all patients as a continuous IV infusion at the dosage of 28μg daily (9μg daily for Cycle 1 Day 1 to Day 7).
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites9

Inclusion Criteria: * 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...

Countries:United StatesCanada
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Recent Changes (Last 90 Days)

MEDIUMAug 1, 2026NCT04260022primaryCompletionDate: changed
MEDIUMAug 1, 2026NCT04260022primaryCompletionDate: changed
MEDIUMAug 1, 2026NCT04260022primaryCompletionDate: changed

Frequently asked questions about Ascentage Pharma HQP1351 bioavailable inhibitor

What is Ascentage Pharma HQP1351 used for?

Ascentage Pharma HQP1351 is an investigational small molecule being studied for the treatment of chronic myeloid leukemia and Philadelphia positive acute lymphoblastic leukemia. It is currently in Phase 1 clinical development for these blood cancers.

What does HQP1351 target?

HQP1351 is a bioavailable inhibitor being developed by Ascentage Pharma. The specific molecular target is not disclosed in the available information, so its mechanism of action is not described here.

Who makes HQP1351?

HQP1351 is being developed by Ascentage Pharma Group International, which trades under the ticker AAPG. The company is conducting clinical trials for this investigational drug in the United States and Canada.

What phase is HQP1351 in?

HQP1351 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. The ongoing Phase 1 trial is actively recruiting participants.

What clinical trials is HQP1351 in?

HQP1351 is being studied in a Phase 1 clinical trial with the identifier NCT04260022. This trial is recruiting 242 participants with refractory chronic myeloid leukemia and Philadelphia positive acute lymphoblastic leukemia in the United States and Canada.

Is HQP1351 the same as Ascentage Pharma HQP1351?

Yes, HQP1351 is the same drug as Ascentage Pharma HQP1351. The drug is referred to by its code name HQP1351 in clinical trial records and is being developed by Ascentage Pharma Group International.