Study title:
A Phase 1, Multicenter, Open-label Trial to Evaluate the Safety of Talimogene
EU record number:
B/BE/16/BVW1
EudraCT number:
2014-005386-67
Company / Sponsor:
Amgen Ltd
Treated organism:
Humans
Indication category:
Treatment of hepatocellular carcinoma (HCC) and metastatic liver tumors (non-HCC)
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)
Route of administration:
Intrahepatic injection
Locations in Belgium:
UCL Cliniques Universitaires Saint Luc (Bruxelles), Universitair Ziekenhuis Gent, Universitair Ziekenhuis Leuven Campus Gasthuisberg, Universitair Ziekenhuis Antwerpen
Foreseen duration:
April 2017 to December 2019
Information for the public
Information related to the decision procedure
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3 March 2017: The Federal Ministers give a final decision (positive) for this trial
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13 December 2016 - The Biosafety Council issues a positive advice (with conditions) for this trial