Safety, tolerability, and efficacy of MTL-CEBPA plus sorafenib in HCC

• Research type

  Research Study

• Full title

  AN OPEN LABEL PHASE 2 STUDY TO EVALUATE THE SAFETY AND EFFICACY OF MTL-CEBPA ADMINISTERED IN COMBINATION WITH SORAFENIB IN PARTICIPANTS WITH HEPATOCELLULAR CARCINOMA (HCC) AND HEPATITIS B OR HEPATITIS C VIRUS (OUTREACH-2)

• IRAS ID

  289605

• Contact name

  Tim Meyer

• Contact email

  t.meyer@ucl.ac.uk

• Sponsor organisation

  MiNA Alpha Limited

• Eudract number

  2020-004378-23

• Duration of Study in the UK

  2 years, 11 months, 12 days

• 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 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.

• REC name

  North East - Newcastle & North Tyneside 2 Research Ethics Committee

• REC reference

  21/NE/0037

• Date of REC Opinion

  31 Mar 2021

• REC opinion

  Further Information Favourable Opinion