NG-641 & pembrolizumab in squamous cell carcinoma of the head and neck
Research type
Research Study
Full title
A multicentre, open-label, dose-escalating, phase Ib, neoadjuvant study of intravenous dosing of NG-641, an oncolytic adenoviral vector expressing a fibroblast activation protein-directed bi-specific T-cell activator antibody fragment (FAP-TAc) and an immune enhancer module (CXCL9/CXCL10/interferon alpha2), as monotherapy or in combination with pembrolizumab in patients with surgically resectable squamous cell carcinoma of the head and neck (Mode Of Action Transgene study- MOAT)
IRAS ID
290504
Contact name
Christian Ottensmeier
Contact email
Sponsor organisation
Akamis Bio
Eudract number
2020-004735-25
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
Among 550,000 cases of head and neck cancer that occur each year across the globe, 90% of them are squamous cell carcinomas of the head and neck (SCCHN), making SCCHN the 6th most common cancer type in the world.
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 your immune system to kill a specific type of cell in your 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 your 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 study will be conducted with participants in 2 groups. The first phase of the study (Cohort A) will involve treating participants treated with study drug until 6 participants show a response to the study drug. The second phase of the study (Cohort B) will include up to 6 participants treated with study drug and pembrolizumab.
Pembrolizumab is a modified antibody (a blood protein produced in the body in order to destroy substances which carry disease). Its an approved drug for use in the UK. Both the groups undergo the same assessments.
The estimated duration of the study from enrolment to follow-up is 24 months.
REC name
South Central - Oxford A Research Ethics Committee
REC reference
20/SC/0425
Date of REC Opinion
29 Jan 2021
REC opinion
Further Information Favourable Opinion