Safety, Tolerability and Anti-tumour Activity Study of MTL-CEBPA Plus Sorafenib
Status:
Not yet recruiting
Trial end date:
2025-05-01
Target enrollment:
Participant gender:
Summary
This is a Phase II study in patients with advanced liver cancer (hepatocellular carcinoma)
caused by a hepatitis B and/or C infection. Participants will be dosed with a combination of
MTL-CEBPA (an experimental treatment) and sorafenib. The MTL-CEBPA is administered once a
week via intravenous infusion for three consecutive weeks followed by a week of rest (one
cycle). Sorafenib is taken orally from Day 8 at a dose of 400 mg twice a day. Participants
will receive cycles of treatment until disease progression, unacceptable toxicity, withdrawal
of consent or death occurs.This combination of treatment was tested in a previous Phase I
study (OUTREACH) which showed anti-tumour activity along with a good safety and toxicity
profile.