Ph1 Study of HMPL-306 in Advanced Hematological Malignancies with mIDH
Research type
Research Study
Full title
A Phase 1, Open-Label, Multicenter Study of HMPL-306 in Advanced Hematological Malignancies with Isocitrate Dehydrogenase (IDH) Mutations
IRAS ID
294379
Contact name
Alisha Khullar
Contact email
Sponsor organisation
Hutchison MediPharma Limited
Eudract number
2020-003751-15
Clinicaltrials.gov Identifier
150936, IND Number
Duration of Study in the UK
1 years, 3 months, 6 days
Research summary
This trial will investigate the safety, tolerability, PK (how a drug is absorbed, distributed and eliminated from the body), PD (how a drug effects to the body), and preliminary efficacy of HMPL-306 administered orally in treatment of participants with advanced relapsed, refractory, or resistant haematological malignancies that harbor IDH mutations.
HMPL-306 is an investigational drug, which is an innovative, small-molecule, orally available; highly selective that targets mutations that are common among those tumours. It belongs to a class of drugs called “IDH Inhibitors”. Proteins called IDH play an important role in cell functioning, in a process where living cells break down molecules to harvest energy they need to grow and divide. Changes (mutations) of this protein can lead to loss of function of these important proteins. The mutated proteins then cause further disruption in cells by influencing the increase of possibly toxic molecules, eventually leading to cancer.
The purpose of this study is to evaluate the safety, tolerability (how well participant stand it and if there are any unwanted symptoms or side effects), determine a safe dose of the study drug, and measure the amount of study drug in samples of the blood.
The study consists of 2 parts: a dose-escalation part (Part 1) and a dose-expansion part (Part 2). The first part of the study is dose escalation, where cohorts of participants will receive ascending oral doses of HMPL-306. In the dose-expansion part, 4 cohorts of participants will receive HMPL-306 to further evaluate safety, tolerability, PK and PD.
Approximately 75 participants globally will take part in this study (approximately 12 to 15 participants are expected in the dose-escalation part and approximately 60 participants are estimated for the dose expansion part). The duration of the study is approximately 36 months. The treatment duration is 28 day continuous dosing treatment cycle.
REC name
London - Central Research Ethics Committee
REC reference
21/LO/0187
Date of REC Opinion
8 Apr 2021
REC opinion
Further Information Favourable Opinion