Give your opinion on a genetically modified medicinal product for advanced or metastatic solid tumours

The FPS Public Health and the FAMHP invite you to participate in the public consultation on a clinical trial with the genetically modified medicinal product BT-001 (TG6030) for advanced or metastatic solid tumours. The public consultation runs from 18 August 2020 to 17 September 2020.

The clinical trial involves the administration of BT-001 directly into the tumour(s) of cancer patients. Between 1 and 4 ml of BT-001 will be injected depending on the size of the lesion(s) to be injected. Participating patients will be administered BT-001 repeatedly: up to four administrations (Phase I, Part A) or until documented disease progression, unacceptable toxicity or patient's refusal (Phase I, Part B and Phase IIa). For a given patient, the dose of BT-001 will be identical at all visits among the 3 doses tested.

The main objective of this trial is to determine the safety and tolerance of BT-001, alone and in combination with pembrolizumab (Keytruda).

The clinical trial will take place at the Clinique Universitaire Saint-Luc, Brussels.

As a citizen, you can give your opinion on this clinical trial application.

For each clinical trial application involving the use of genetically modified organisms, the government organises a 30-day public consultation (in accordance with the Royal Decree of 21 February 2005). You therefore have access to the various data from the application file, as well as to an online form to send your comments or ask questions about this file.

The public consultation runs until 17 September 2020 inclusive.

General information on public consultations on GMOs (French version).

Last updated on
24/09/2020