Ph1 study of HMPL-306 in Locally Advanced Solid Tumors w IDH Mutations
Research type
Research Study
Full title
A Multicenter, Open-Label Phase I Study Evaluating the Safety and Tolerability of HMPL-306 in Subjects with Locally Advanced or Metastatic Solid Tumors with IDH Mutations
IRAS ID
295992
Contact name
Hendrik - Tobias Arkenau
Contact email
Sponsor organisation
Hutchison MediPharma Limited
Eudract number
2020-003729-44
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 4 months, 30 days
Research summary
This is a phase 1, open-label, multicenter study to evaluate the safety and tolerability (how well the participant can tolerate the side effect) of HMPL-306 administered orally in the treatment of participants with locally advanced or metastatic solid tumours with IDH mutation.
HMPL-306 is a small-molecule, orally available, highly selective, and potent dual inhibitor of IDH1 and IDH2 mutants. HMPL-306 is available in tablet formulation of 2 strengths: 25 mg and 100 mg for this clinical trial.
The study consists of 2 parts:
Part 1 (dose escalation) and Part 2 (dose expansion). The dose escalation part will determine the Maximum tolerated dose/ Recommended phase 2 dose (MTD/RP2D). The dose expansion part will administer the MTD/RP2D to 4 cohorts of participants to further evaluate the safety, tolerability, PK, and PK of the study drugIn total, approximately 110-115 participants globally will take part in this study. Part 1- at least 1 participant will be enrolled to dose levels 1, 2, and 3. At least 3 participants will be enrolled to dose level 4. Part 2 - approximately 20 evaluable participants (15 in Cohort C-1) per cohort will be enrolled; for a total of approximately 95 participants. It will last approximately 36 months.
REC name
London - Central Research Ethics Committee
REC reference
21/LO/0326
Date of REC Opinion
9 Jun 2021
REC opinion
Further Information Favourable Opinion