NCT02716012

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

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

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 75 (actual)
• Sponsor: Mina Alpha Limited · Industry
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hepatocellular Carcinoma
• Liver Cancer

Interventions

Type	Name	Description
DRUG	MTL-CEBPA	Intravenous administration
DRUG	Sorafenib 200mg	Sorafenib tablets

Timeline

• Start date: 2016-03-01
• Primary completion: 2025-07-01
• Completion: 2025-07-31
• First posted: 2016-03-22
• Last updated: 2025-03-10

Locations

11 sites across 3 countries: Singapore, Taiwan, United Kingdom