Spots Global Cancer Trial Database for First-in-Human Safety, Tolerability and Antitumour Activity Study of MTL-CEBPA in Patients With Advanced Liver Cancer
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Trial Identification
Brief Title: First-in-Human Safety, Tolerability and Antitumour Activity Study of MTL-CEBPA in Patients With Advanced Liver Cancer
Official Title: A First-in-Human, Multi-centre, Open-label, Phase 1a/b Clinical Study With RNA Oligonucleotide Drug MTL-CEBPA to Investigate Its Safety, Tolerability, and Antitumour Activity in Patients With Advanced Liver Cancer
Study ID: NCT02716012
Study Description
Brief Summary: MNA-3521-011 study is a multi-centre, open-label, first-in-human, phase 1a/b clinical study dose/dose frequency escalation followed by a cohort expansion part. MTL-CEBPA is administered as monotherapy or in combination with sorafenib to patients with advanced hepatocellular carcinoma and cirrhosis of the liver. All participants will be considered unsuitable for liver tumour resection and/or is refractory to radiotherapy and other loco-regional therapies. MTL-CEBPA consists of a double stranded RNA formulated into a SMARTICLES® liposomal nanoparticle and is designed to activate the CEBPA gene.
Detailed Description:
Eligibility
Minimum Age: 16 Years
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
National University Hospital, Singapore, , Singapore
National Taiwan University Hospital, Taipei, , Taiwan
University Hospitals Birmingham NHS Foundation Trust, Birmingham, , United Kingdom
Cambridge University Hospitals NHS Trust, Cambridge, , United Kingdom
The Beatson West of Scotland Cancer Centre, Glasgow, , United Kingdom
Clatterbridge Cancer Centre NHS Foundation Trust, Liverpool, , United Kingdom
Guy's and St. Thomas' NHS Foundation Trust, London, , United Kingdom
Imperial College Healthcare NHS Trust, London, , United Kingdom
The Royal Free London NHS Foundation Trust, London, , United Kingdom
University College London Hospitals NHS Foundation Trust, London, , United Kingdom
Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle, , United Kingdom
Contact Details
Name: Dr Debashis Sarker, MBChB, MRCP
Affiliation: Guy's and St Thomas' NHS Foundation Trust and King's College London
Role: PRINCIPAL_INVESTIGATOR
Name: Professor Nagy Habib, FRCS
Affiliation: Mina Alpha Limited
Role: STUDY_DIRECTOR
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