A Phase I/IIa study of TG6002 (VV TK-RR-FCU1) administered by intravenous (IV) infusions in combination with oral flucytosine (5-FC) in patients with advanced gastro-intestinal (GI) tumors

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Study title: 
A Phase I/IIa study of TG6002 (VV TK-RR-FCU1) administered by intravenous (IV) infusions in combination with oral flucytosine (5-FC) in patients with advanced gastro-intestinal (GI) tumors
Date receipt dossier: 
18 Apr 2018
EU record number: 
B/BE/18/BVW1
EudraCT number: 
2018-000039-28
Pharmaceutical study code: 
TG6002.02
Company / Sponsor: 
Transgene
Phase: 
I/II a
Treated organism: 
Humans
Indication category: 
Cancer therapy
Disease: 
Patients with advanced gastro-intestinal (GI) tumors
Therapeutic approach: 
Suicide gene/ pro drug
Genetic modification: 
Engineered replicative oncolytic vaccinia virus (VV) derived from the Copenhagen strain. It contains three genetic modifications: 1) deletion of the viral thymidine kinase (TK) gene, 2) deletion of the viral ribonucleotide reductase (RR) gene and 3) insertion of the chimeric yeast FCU1 suicide gene in the TK locus.
Method of transfer of nucleic acid of interest: 
Vaccinia virus
Administered biological material: 
Replicative oncolytic vaccinia virus
Route of administration: 
Intravenous
Locations in Belgium: 
Institut Jules Bordet (Bruxelles)
Nr of subjects: 
A maximum of 59 patients will be recruited in this trial.
Foreseen duration: 
The clinical trial is expected to start in Q4 2018 with the first patient recruited at this time. The study is anticipated to last 30 months. Therefore, the foreseen period of time of the release is Q4 2018 to Q3 2021.
Type of procedure: 
Contained use and Deliberate release
Current status: 
Authorized

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