B/BE/19/BVW3 - Summary Notification Information Format (SNIF) Public information presented according to the provisions of Directive 2001/18/EC
Long title
A Phase 1, Multi-center, Open-label, Dose De-escalation Study to Evaluate the Safety and efficacy of Talimogene Laherparepvec in Pediatric Subjects With Advanced Noncentral Nervous System Tumors That are Amenable to Direct Injection
Date receipt dossier
EU record number
B/BE/19/BVW3
EudraCT number
2015-003645-25
Company / Sponsor
Amgen Ltd
Phase
I
Treated organism
Humans
Indication category
Cancer therapy
Disease
Pediatric subjects with advanced non-central nervous system tumors
Therapeutic approach
Immunotherapy
Genetic modification
Insertion of a gene expressing granulocyte-macrophage colony-stimulating factor (hGM-CSF) - Functional deletion of two genes (ICP34.5 and ICP47) of the HSV-1 genome
Method of transfer of nucleic acid of interest
Herpes simplex virus 1 (HSV-1)
Administered biological material
Recombinant HSV-1 D(ICP34,5 & ICP47)
Route of administration
Intralesional
Locations in Belgium
Universitair Ziekenhuis Gent
Nr of subjects
2 subjects foreseen in Belgium (10 subjects in Europe)
Foreseen duration
2 years 11 months, starting in June 2019
Type of procedure
Contained use and Deliberate release
Current status
Authorized