EMR200647-001 MERCK TRAP
Research type
Research Study
Full title
A Phase I, open-label, multiple-ascending dose trial to investigate the safety, tolerability, pharmacokinetics, biological and clinical activity of MSB0011359C in subjects with metastatic or locally advanced solid tumors and expansion to selected indications.
IRAS ID
204758
Contact name
Martin Forster
Contact email
Sponsor organisation
Merck KGaA
Eudract number
2015-004366-28
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 0 months, 1 days
Research summary
MSB0011359C (M7824) is an investigational drug that is being evaluated for the treatment of patients with solid tumours. There are two parts to this research study: a dose-escalation part and a dose-expansion part. Only The dose expansion part of the study will be performed in the UK. In the dose-expansion part of the study, the study drug will be given at a dose that was well-tolerated in the dose-escalation part of the study and will be administered to a larger number of people to evaluate how effective it is in treating certain types of solid tumors. The main purpose of the dose expansion part of this Phase I study is to evaluate how effective the study drug is in treating certain types of solid tumors when given once every two weeks.
REC name
London - City & East Research Ethics Committee
REC reference
16/LO/0769
Date of REC Opinion
27 Jul 2016
REC opinion
Further Information Favourable Opinion