NEBULA clinical study
Research type
Research Study
Full title
A multicentre, open-label, non-randomized, phase 1a/1b study of NG 641, a tumour-selective and transgene-expressing adenoviral vector, in combination with nivolumab in patients with metastatic or advanced epithelial tumours (NEBULA)
IRAS ID
1004337
Contact name
Andrew Fox
Contact email
Sponsor organisation
Akamis Bio (form. PsiOxus Therapeutics Limited)
Eudract number
2021-005570-26
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-641 is an experimental gene therapy medicinal product. It is a virus with four additional genes inserted. A gene is information in the form of deoxyribonucleic acid (DNA) required for making proteins or other molecules. The virus should multiply only in cancer cells and the products of these four genes will help to activate a type of white blood cell called “T cells”, which help the immune system to kill a specific type of cell in the immune system called “fibroblasts”. Fibroblasts are not cancer cells, but it is thought they can help cancer cells grow. As well as killing fibroblasts within tumours, the additional genes in the virus are also thought to help the immune system to locate and kill the cancer cells more effectively. NG-641 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, Nivolumab, works by changing the action of the immune system, directing it to attack cancer cells. Nivolumab belongs to a class of drugs known as monoclonal antibodies. Nivolumab 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 12 months.REC name
London - West London & GTAC Research Ethics Committee
REC reference
21/LO/0869
Date of REC Opinion
8 Feb 2022
REC opinion
Further Information Favourable Opinion