Safety and Tolerability of MTL-CEBPA in Advanced Liver Cancer
Research type
Research Study
Full title
A First-in-Human, multi-centre, open-label, Phase 1 clinical study with RNA oligonucleotide drug MTL-CEBPA to investigate its safety and tolerability in patients with advanced liver cancer.
IRAS ID
186547
Contact name
Robert Nutbrown
Contact email
Eudract number
2015-003051-21
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
20332 (CANC 4818), UKCRN ID
Duration of Study in the UK
1 years, 6 months, 24 days
Research summary
This is a First in Human study of a new single agent (MTL-CEBPA) in patients with advanced cancer of the liver. The study is in two parts. The first part (Part 1) is a dose escalation study in 6 cohorts of patients, the second part (Part 2) is a dose expansion study in patients with hepatocellular carcinoma.
All participants will be refractory to loco-regional therapy and/or sorafenib or treatments such as surgery, radiofrequency tumour ablation, and transarterial chemoembolisation.
MTL-CEBPA is a double stranded RNA that upregulates the CEBPa gene, It has been shown that patients with tumours expressing low CEBPa have shorter survival compared to patients with tumours expressing higher CEBPa expression.
This study will take place in the UK, in specialised early phase units.
REC name
North East - Newcastle & North Tyneside 2 Research Ethics Committee
REC reference
15/NE/0406
Date of REC Opinion
27 Jan 2016
REC opinion
Further Information Favourable Opinion