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 April, 2018

EU record number

B/BE/18/BVW1

EudraCT number

2018-000039-28

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

Pharmaceutical study code

TG6002.02