Neoplasms

All Conditions

Digestive System Diseases

Infections

Symptoms and General Pathology

Carcinoma

Carcinoma, Hepatocellular

Hepatitis A

Hepatitis C

Hepatitis

Hepatitis B

Virus Diseases

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Liver Diseases

Gastrointestinal Diseases

Hepatitis, Viral, Human

Communicable Diseases

Enterovirus Infections

Picornaviridae Infections

RNA Virus Infections

Adenocarcinoma

Liver Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Blood-Borne Infections

Flaviviridae Infections

Hepadnaviridae Infections

DNA Virus Infections

Antineoplastic Agents

All Drugs and Chemicals

Sorafenib

Protein Kinase Inhibitors

Enzyme Inhibitors

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

Oral sorafenib 400mg twice a day commencing Day1

Administered once every 3 weeks on Day 1 of each 3 week cycle.

MTL-CEBPA

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.

After a participant has signed the consent form to confirm they wish to participate in the study a number of assessments (screening) will be completed to determine whether they are suitable to be enrolled in the study. Prior to the the first dose of experimental drug (MTL-CEBPA) a 2:1 randomisation programme will allocate to which arm the person will be allocated. For participants allocated to the combination treatment arm, MTL-CEBPA will be given via infusion on the first day (Cycle 1 Day 1) of the study. It will subsequently be administered every 21 days. Sorafenib tablets (a drug which is already used to treat liver cancer) will be started on the eighth day of the study and taken daily whilst the participant is in the study. If the participant is tolerating the combination of drugs and there is no evidence that the cancer is advancing they will continue to receive cycles (21 days in length) of treatment. For participants allocated to the single treatment arm, sorafenib tablets will be started on Day 1. All participants will have contrast-enhanced CT scans of the chest, abdomen and pelvis at the beginning of the study and then every 8 weeks whilst in the study. Assessments will be completed throughout the study to ensure the combination of drugs is safe. These will include recording any adverse events (untoward medical occurrences), vital signs (such as blood pressure, pulse, body temperature, and breathing rates), ECG, and completing blood tests. Blood samples, analysed in both local (hospital/clinic site) and central laboratories (ie, facilities independent of hospital/clinic labs) will be taken throughout the study. The maximum amount of blood taken in any 28-day treatment cycle is approximately 182 mL. A patient questionnaire will be used to assess changes in health-related quality of life for participants. The questionnaire will be used for all participants in the study and will be completed every 3 weeks. All participants will be offered an optional liver tumour biopsy prior to being administered study treatment and again if clinically feasible during treatment.

Participants will be randomised 2:1 to receive either both the experimental drug, MTL-CEBPA, and sorafenib tablets or sorafenib tablets alone

Radomised Phase II Study of MTL-CEBPA Plus Sorafenib or Sorafenib Alone

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)

Change from baseline CT scan using blinded central review of Response Evaluation Criteria in Solid Tumours v.1.1 and compare between the two arms

To compare the health-related quality of life (HRQoL) of MTL-CEBPA in combination with sorafenib compared to sorafenib alone as assessed by EORTC-QLQ-C30 plus EORTC-QLQ-HCC18 QOL questionnaires.

To compare overall survival (OS) between the two arms using statistical analysis

Compare the incidence of AEs/serious AEs (SAE) graded according to toxicity criteria (CTCAE v5.0 between the two arms

Mina Alpha Limited

Hematinics

Liver Extracts

MTL-CEBPA administered weekly, twice weekly or thrice weekly over 3 weeks followed by 1 week of rest defining a 28-day cycle.

MTL-CEBPA is administered weekly or twice weekly in combination with sorafenib over 3 weeks followed by 1 week of rest defining a 28-day cycle.

MTL-CEBPA is administered weekly or twice weekly for 2 cycles (28-day cycle) followed by 2 cycles of sorafenib

Sorafenib 200mg

Dr Debashis Sarker, MBChB, MRCP

Professor Nagy Habib, FRCS

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.

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

Frequency of adverse events graded according to NCI CTCAE v5.0

Increase or decrease in tumour measurement using Response Evaluation Criteria in Solid Tumours (RECIST) reports

Frequency of treatment-related adverse events graded according to NCI CTCAE v5.0

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Radomised Phase II Study of MTL-CEBPA Plus Sorafenib or Sorafenib Alone	NCT04710641	Hepatocellular ... Hepatitis B Hepatitis C	MTL-CEBPA Sorafenib	18 Years -	Mina Alpha Limited
First-in-Human Safety, Tolerability and Antitumour Activity Study of MTL-CEBPA in Patients With Advanced Liver Cancer	NCT02716012	Hepatocellular ... Liver Cancer	MTL-CEBPA Sorafenib 200mg	16 Years -	Mina Alpha Limited

Spots Global Cancer Trial Database for sarna

Every month we try and update this database with for sarna cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for sarna

Every month we try and update this database with for sarna cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for sarna cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.