B/BE/20/BVW3 - Summary Notification Information Format (SNIF)Public information presented according to the provisions of Directive 2001/18/EC
Long title
A Phase I/IIa study of intra-tumoral BT-001 (TG6030) administered alone and in combination with pembrolizumab in patients with cutaneous or, subcutaneous lesions or easily injectable lymph nodes of metastatic/advanced solid tumors
Date receipt dossier
EU record number
B/BE/20/BVW3
EudraCT number
2020-000505-80
Company / Sponsor
Transgene
Phase
I/II a
Treated organism
Humans
Indication category
Cancer therapy
Disease
Patients with cutaneous or, subcutaneous lesions or easily injectable lymph nodes of metastatic/advanced solid tumors
Therapeutic approach
Suicide gene/ pro drug
Genetic modification
Replicative oncolytic vaccinia virus derived from the Copenhagen strain, genetically modified by inactivation of its thymidine kinase (TK) and ribonucleotide reductase (RR) genes and by addition of genes encoding for the human granulocyte-macrophage colony-stimulating factor (hGM-CSF) cytokine and for a monoclonal antibody targeting the Cytotoxic T-Lymphocyte-Antigen 4 (CTLA-4).
Method of transfer of nucleic acid of interest
Vaccinia virus
Administered biological material
Replicative oncolytic vaccinia virus
Route of administration
Intratumoral
Locations in Belgium
Cliniques universitaires Saint-Luc (UCLouvain)
Nr of subjects
Max 48 patients in the Phase I. The number of patients needed in Phase IIa will be defined based on Phase I results.
Foreseen duration
The foreseen period of time of the release is Q4 2020 to Q3 2024.
Type of procedure
Contained use and Deliberate release
Current status
Assessed
Pharmaceutical study code
BT-001.01