Phase I multicentre study of TG1024 (Adenovirus interleukin 2) in patients with metastatic melanoma or other advanced solid tumor cancers

Study title: 
Phase I multicentre study of TG1024 (Adenovirus interleukin 2) in patients with metastatic melanoma or other advanced solid tumor cancers
EU record number: 
B/BE/03/B3
Pharmaceutical study code: 
TG1024.01
Company / Sponsor: 
Transgene S.A.
Treated organism: 
Humans
Indication category: 
Cancer therapy
Disease: 
Metastatic melanoma or other advanced solid tumors
Therapeutic approach: 
Immunotherapy
Genetic modification: 
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: 
intratumoral
Locations in Belgium: 
Erasme Hospital, Brussels
Nr of subjects: 
not specified (up to 51 patients in Switzerland and Belgium)
Foreseen duration: 
about 12 months
Type of procedure: 
Contained use and Deliberate release
Current status: 
Authorized
Notes: 
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.

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