Phase 1 study of NG-350A plus pembrolizumab in metastatic or advanced epithelial tumours
Research type
Research Study
Full title
A multicentre, open-label, non-randomized, phase 1a/1b study of NG-350A, a tumour-selective anti-CD40-expressing adenoviral vector in combination with pembrolizumab in patients with metastatic or advanced epithelial tumours
IRAS ID
1005052
Contact name
Andrew Fox
Contact email
Sponsor organisation
Akamis Bio
Eudract number
2022-000335-22
Clinicaltrials.gov Identifier
Research summary
Worldwide, almost 10 million deaths in 2020 were estimated to be due to cancer. Despite the introduction of multiple new therapies, the overall burden of cancer incidence and mortality is growing worldwide and there remains a critical need for new and effective treatments.
NG-350A is an experimental gene therapy medicinal product. A gene is information in the form of deoxyribonucleic acid (DNA) required for making proteins or other molecules. This additional drug is called an ‘anti-CD40 antibody’ and is designed to help the immune system to attack cancer cells:
1. The virus (study drug) infects only tumour cells
2. The virus (study drug) forces tumour cells to produce another drug (anti-CD40 antibody)
3. This additional drug is designed to help activate your immune system
4. Activated immune cells then further attack your cancer cells.
NG-350A can multiply in and kill cancer cells, but it is not expected to have an effect on normal cells.
The other drug used in this study, Pembrolizumab, works by changing the action of the immune system, directing it to attack cancer cells. Pembrolizumab belongs to a class of drugs known as monoclonal antibodies. Pembrolizumab is approved for use in the UK.
The study will be conducted with participants in 2 phases. The first phase will involve up to 30 patients and is designed to determine the safest tolerated dose of study drug. The second phase will investigate how well the study drug works in groups of patients with specific tumour types and include approximately 168 patients.
The estimated duration of the study from enrolment to follow-up is 112 weeks.REC name
London - West London & GTAC Research Ethics Committee
REC reference
22/LO/0161
Date of REC Opinion
10 May 2022
REC opinion
Further Information Favourable Opinion