Fortress NG-350A-03
Research type
Research Study
Full title
A multicentre, open-label, non-randomized, phase 1b trial of NG-350A, a tumour-selective anti-CD40-expressing adenoviral vector, in combination with chemoradiotherapy in locally advanced rectal cancer (FORTRESS)
IRAS ID
1011106
Contact name
Robert Maietta
Contact email
Sponsor organisation
Akamis Bio Ltd.
ISRCTN Number
ISRCTN12595783
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 derived from a virus. The added 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 the immune system
4. Activated immune cells then further attack the cancer cells.NG-350A can multiply in and kill cancer cells, but it is not expected to have an effect on normal cells.
The study will include approximately 30 patients with locally advanced rectal cancer (LARC) that will all receive NG-350A. The trial is designed so that the initial anti-cancer effect of NG-350A plus standard chemotherapy and radiotherapy can be tested during a short active study treatment period of 12 weeks, while hospital sites can give additional standard-of-care treatment during the trial follow-up period.
The study will determine the number of patients that achieve a complete response in 12, 18 and 36 weeks after starting NG-350A. The study will also investigate what side effects people have and what percentage of people experience these.
The estimated duration of follow up during the study from joining to the end is at least 1 year up to a maximum follow-up of three years.
REC name
North East - York Research Ethics Committee
REC reference
24/NE/0216
Date of REC Opinion
28 Jan 2025
REC opinion
Further Information Favourable Opinion