Phase 1B, PK Safety and Efficacy of Orally Administered HQP1351
Research type
Research Study
Full 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)
IRAS ID
1006032
Contact name
Yifan Zhai
Contact email
Sponsor organisation
Ascentage Pharma Group Inc.
Eudract number
2022-000126-19
Clinicaltrials.gov Identifier
Research summary
The purpose of this Phase 1b study is to establish the safety and efficacy of an investigational drug HQP1351, and to determine the recommended dose for a Phase 2 study.
Adult patients with either Chromic Myeloid Leukemia (CML) or Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia (ALL), who have been treated with two approved drugs for their disease (except if the patients has a T315l mutation), and whose treatment has been stopped because the drugs were no longer effective, or had side effects that could not be tolerated, are eligible to take part. Approximately 40 patients are expected to take part in this study. Participants may receive treatment for the study for up to two years, and a follow up period, where participants are contacted to check their health, of up to 8 years. If participants are benefitting from treatment, they may continue to receive the study drug, at the discretion of the Investigator and sponsor.
Both CML and ALL are types of cancer that affect the white blood cells.
The underlying cause of CML is a chromosomal abnormality, which is produced in 95% of patients, where the bone marrow produces too many myeloid cells (immature blood cells that are not fully developed and do not work properly). CML tends to progress slowly over many years, and is different to other types of leukemia. CML represents about 15-20% of adult leukemias.
ALL is a rare disease,, with around 790 people diagnosed with the condition each year in the UK. ALL progresses quickly and aggressively.
HQP1351 is a new drug that is active against a broad spectrum of mutations. Standard drugs targeting mutations belong to the class of drugs called tyrosine kinase inhibitors (TKIs). However, mutations can make these standard drugs ineffective. HQP1351 was developed to have a broad effect against mutated forms of certain gene. Therefore, this drug could potentially overcome the pitfalls of the standard drugs and be a possible new treatment.REC name
North East - York Research Ethics Committee
REC reference
22/NE/0129
Date of REC Opinion
16 Sep 2022
REC opinion
Further Information Unfavourable Opinion