B/BE/15/BVW2 - Informatie fiche bestemd voor het publiek (voorbereid door de kennisgever)12 January 2016 - The Biosafety Council issues a positive advice (with conditions) for this trial
EU record number
B/BE/15/BVW2
EudraCT number
2015-003011-38
Company / Sponsor
Amgen Ltd
Phase
I and III
Treated organism
Humans
Indication category
Cancer therapy
Disease
Metastatic Squamous Cell Carcinoma of the Head and Neck
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
Institut Jules Bordet (Bruxelles), GasthuisZusters Antwerpen (Campus Sint-Augustinus Wilrijk)
Nr of subjects
270 patients in Europe, with a max. of 10 in Belgium
Foreseen duration
January 2016 to February 2022
Type of procedure
Contained use and Deliberate release
Current status
Authorized
Pharmaceutical study code
20130232