First-in-Human Safety, Tolerability and Antitumour Activity Study of MTL-CEBPA in Patients With Advanced Liver Cancer

Study ID
NCT02716012

Study type
Interventional

Study phase
Phase 1

Study status
Active, not recruiting

Trial Acronym

OUTREACH

Trial 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.

More informations

Trial Starting Date

Mar 01,2016

Requirements

Gender All
Minimum age 16 Years
Maximum age N/A

Enrollement Limit