The FPS Public Health and the FAMHP invite you to participate in the public consultation on a clinical trial testing the genetically modified oncolytic virus VSV-GP (BI 1831169), for the treatment of patients with various types of advanced cancer (solid tumours). The public consultation runs from 11 January 2022 to 10 February 2022.
For each clinical trial application for the use of a genetically modified organisms, the government organises a thirty-day public consultation, in accordance with the Royal Decree of 21 February 2005. As a citizen, you can give your opinion on this clinical trial application with the genetically modified medicinal product VSV-GP (BI 1831169) for the treatment of various types of advanced cancer (solid tumours).
This clinical trial will investigate the safety and tolerability of the oncolytic virus VSV-GP (BI 1831169) in people with certain tumour types. The study will consist of two parts, each with different participants. In part one the oncolytic virus VSV-GP (BI 1831169) will be tested on its own, at different dose levels. It will be administered five times over a period of three months by injection directly into the tumour (intratumoral, i.t.), by injection directly into the bloodstream (intravenous, i.v.) or by a combination of both injections, intratumoral and intravenous. In second part of the study, the oncolytic virus will be tested at different dose levels in combination with another cancer drug, ezabenlimab.
VSV-GP (BI 1831169) has not yet been used as a treatment in humans, which means that the study outlined above is a first-in-human (FIH) clinical trial. Previous studies have shown VSV-GP to be safe and effective in non-clinical animal studies.
The clinical trial will take place at Saint-Luc University Hospital in Brussels from the second quarter of 2022 to the first quarter of 2025.
How to give your opinion?
The public consultation runs until 10 February 2022 inclusive. You can access the various data in the application file, as well as an online form to send your comments or ask your questions.