Safety and efficacy of MTL-CEBPA randomised with sorafenib in HCC

• Research type

  Research Study

• Full title

  AN OPEN LABEL, RANDOMISED, PHASE 2 STUDY TO EVALUATE THE SAFETY AND EFFICACY OF MTL-CEBPA ADMINISTERED IN COMBINATION WITH SORAFENIB OR SORAFENIB ALONE, IN TKI NAÏVE PARTICIPANTS WITH PREVIOUSLY TREATED ADVANCED HEPATOCELLULAR CARCINOMA (HCC) AND HEPATITIS B OR HEPATITIS C VIRUS (OUTREACH2)

• IRAS ID

  1004318

• Contact name

  Alison Adderkin

• Contact email

  alison@minatx.com

• Sponsor organisation

  MiNA Alpha Ltd

• Eudract number

  2021-005431-23

• Clinicaltrials.gov Identifier

  NCT04710641

• Research 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 randomised (randomly assigned) to a combination of MTL-CEBPA (an experimental treatment) and
  sorafenib or sorafenib alone. The MTL-CEBPA is administered once a week via intravenous infusion for three consecutive weeks
  followed by a week of rest (one cycle). When assigned with MTL-CEBPA, Sorafenib is taken orally from Day 8 at a dose of 400 mg twice a day. When assigned to just Sorafenib, it is taken orally from Day 1 at a dose of 400mg 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

• REC name

  London - Hampstead Research Ethics Committee

• REC reference

  22/LO/0019

• Date of REC Opinion

  16 Mar 2022

• REC opinion

  Further Information Favourable Opinion