B/BE/17/BVW2 - Summary Notification Information Format (SNIF) Public information presented according to the provisions of Directive 2001/18/EC
EU record number
B/BE/17/BVW2
EudraCT number
2015-005480-16
Company / Sponsor
Amgen Ltd
Phase
Ib
Treated organism
Humans
Indication category
Cancer therapy
Disease
Subjects with triple negative breast cancer and colorectal cancer with liver metastases
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
Intrahepatic injection
Locations in Belgium
UCL Cliniques Universitaires Saint Luc (Bruxelles), Universitair Ziekenhuis Gent
Nr of subjects
5 subjects foreseen in Belgium (36 subjects for the whole clinical trial)
Foreseen duration
January 2018 to December 2021
Type of procedure
Contained use and Deliberate release
Current status
Authorized