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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