MTL-CEBPA + Sorafenib for Liver Cancer

(OUTREACH2 Trial)

Recruiting at 1 trial location

Overseen By Nagy Habib, ChM

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Mina Alpha Limited

Must be taking: Active HBV therapy

Must not be taking: Investigational drugs, Live vaccines

Disqualifiers: Child-Pugh B/C, CNS metastases, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

8 Participants Needed

Trial Summary

What is the purpose of this trial?

This is a Phase II study in patients with advanced liver cancer (hepatocellular carcinoma) as a result of hepatitis B and/or C infection. Participants will be dosed with either MTL-CEBPA (an experimental treatment) and sorafenib or sorafenib alone. The MTL-CEBPA is administered once every 3 weeks via intravenous infusion. Sorafenib is taken orally from Day 8 for the combination group or Day 1 for the sorafenib alone group at a dose of 400 mg twice a day. Participants will receive 3 week cycles of treatment until disease progression, unacceptable toxicity, withdrawal of consent or death occurs. The combination of MTL-CEBA and sorafenib 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.

Eligibility Criteria

This trial is for adults with advanced liver cancer due to hepatitis B/C, who have a life expectancy of over 3 months and are not suitable for surgery or liver transplant. They should be new to tyrosine kinase inhibitors like sorafenib and must have normal organ function tests. Pregnant women, those with severe liver impairment (Child-Pugh B/C), recent serious cardiovascular issues, other active cancers, or known allergies to the drugs tested cannot participate.

Inclusion Criteria

White Blood Cell (WBC) ≥2.0 x 109/L

At least one measurable liver lesion (RECIST v1.1) assessed by the investigator

I am fully active or restricted in physically strenuous activity but can do light work.

Exclusion Criteria

Participants with a screening diastolic blood pressure >90 mm Hg

Participants who received investigational drug(s) within the last 30 days prior to study treatment initiation

I have not had sepsis, issues with bile drainage, jaundice, or brain function problems recently.

Treatment Details

Interventions

• MTL-CEBPA
• Sorafenib

Trial Overview The study compares two approaches: one group receives MTL-CEBPA via IV every three weeks plus oral Sorafenib starting Day 8; the other gets only Sorafenib from Day 1. The goal is to see if adding MTL-CEBPA improves outcomes in hepatocellular carcinoma patients who've had hepatitis B/C.

Participant Groups

Group I: MTL-CEBPA in combination with sorafenib Experimental Treatment 2 Interventions

Intravenous infusion of MTL-CEBPA 130mg/m2 given once every 3 weeks. Oral sorafenib 400mg twice a day will commence C1D8.

Group II: Sorafenib alone Active Control 1 Intervention

Oral sorafenib 400mg twice a day commencing Day1

Who Is Running the Clinical Trial?

Mina Alpha Limited

Lead Sponsor

Trials

3

Recruited

130+