MTL-CEBPA IN COMBINATION WITH A PD-1 INHIBITOR IN SOLID TUMOURS V1.1
Research type
Research Study
Full title
AN OPEN LABEL PHASE 1A/B STUDY OF MTL-CEBPA IN COMBINATION WITH A PD-1 INHIBITOR (PEMBROLIZUMAB) IN ADULT PATIENTS WITH ADVANCED SOLID TUMOURS (TIMEPOINT)
IRAS ID
266862
Contact name
Ruth Plummer
Contact email
Eudract number
2019-002231-28
Duration of Study in the UK
2 years, 1 months, 17 days
Research summary
This study has two parts.
Part 1a is called “dose escalation” which means we are trying to find out how much of the drug (MTL-CEBPA) we can give safely (in combination with another drug called pembrolizumab) and what the side effects might be.
Part 1b is called “cohort expansion”. The purpose of Part 1b is to continue gaining information on the safety of the combination of drugs (MTL-CEBPA plus pembrolizumab) and to check if they can potentially reduce the size of the tumour.
The overall number of patients expected to take part in the study will depend on how safe and how much anti-tumour effect is observed during the study. For the first part of the study (1a) a maximum of 18 patients will be included; for the second part (1b) a maximum of 90 patients will be included.
This is not a randomized study participants will take the next available space on the study and will be administered both MTL-CEBPA and pembrolizumab.
Participants will remain in the study taking study drugs until either death, they choose to withdraw from the study, or the Sponsor decides to terminate the study.
The study will be conducted in approximately 10 specialised centres and university hospitals in S.E. Asia, United Kingdom, and US.
REC name
North East - Newcastle & North Tyneside 2 Research Ethics Committee
REC reference
19/NE/0312
Date of REC Opinion
13 Nov 2019
REC opinion
Further Information Favourable Opinion