Phase I multicentre study of TG1024 (Adenovirus interleukin 2) in patients with metastatic melanoma or other advanced solid tumor cancers
EU record number:
Pharmaceutical study code:
Company / Sponsor:
Metastatic melanoma or other advanced solid tumors
gene coding for human interleukin 2
Method of transfer of nucleic acid of interest:
Human adenovirus C serotype 5 deleted in E1 and E3
Administered biological material:
Recombinant Adenovirus D (E1, E3)
Route of administration:
Locations in Belgium:
Erasme Hospital, Brussels
Nr of subjects:
not specified (up to 51 patients in Switzerland and Belgium)
about 12 months
Type of procedure:
Contained use and Deliberate release
In June 2004 the notifier sent additional data and made a request to alleviate one of the conditions of the authorization. As a result of this request, a revised advice was drafted by the Biosafety Advisory Council and a second authorization was delivered by the Competent Authority.
Information for the public
Public information presented according to the provisions of Directive 2001/18/EC
Information related to the decision procedure
26 March 2004 & 5 July 2004: The Biosafety Advisory Council issues a positive advice (with conditions) for this trial.
29 April 2004 & 8 July 2004: The Federal Public Service Health, Food chain safety and Environment gives a final decision (positive) for this trial.