Title

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

Company or sponsor

Transgene S.A.

Pharmaceutical study code

TG1024.01

Phase

I/II

Unicenter/multicenter study

multicenter but only one center in Belgium

Installation

Hôpital Erasme, Bussels

Authorisation procedure 1

contained use, subsequent use (see relevant regulation)

Application number

SBB 219 2004/0572

User(s)

Prof. T. Velu

Receipt date

23/04/2004 (02/02/2004 for authorisation procedure 2)

Biosafety Council meeting date

25/03/2004

Authorisation date

27-09-2004

Authorisation procedure 2

deliberate release for research and development purposes (see regulation in french - in dutch)

Application number

B/BE/03/B3

Status

enrolment of patients stopped on 11 April 2005