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

Study 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
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: 
13 Aug 2020
EU record number: 
B/BE/20/BVW3
EudraCT number: 
2020-000505-80
Pharmaceutical study code: 
BT-001.01
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: 
Under evaluation