B/BE/21/BVW4 - Information sheet for the public (prepared by the notifier)Public information presented according to the provisions of Directive 2001/18/EC
Long title
An Open-Label, Multicenter, Non-Randomized, Dose-Confirmation and Cohort-Expansion Phase 1b Study to Evaluate the Safety, Tolerability, and Anti-Tumor Activity of ATP128, VSV-GP128 and BI 754091, in Patients with Stage IV Colorectal Cancer
Date receipt dossier
EU record number
B/BE/21/BVW4
EudraCT number
2019-000728-16
Company / Sponsor
AMAL Therpeutics
Phase
Ib
Treated organism
Humans
Indication category
Cancer therapy
Disease
Colorectal cancer
Therapeutic approach
Immunotherapy
Genetic modification
VSV-GP128 is a recombinant live-attenuated Vesicular Stomatitis Virus (VSV), modified to minimize the potential of neurotoxicity for humans and skin disease in animals, and engineered to contain cancer antigens, which help it induce an immune response against colorectal tumour cells.
Method of transfer of nucleic acid of interest
recombinant live-attenuated Vesicular Stomatitis Virus
Administered biological material
Genetically modified virus
Route of administration
Intravenous
Locations in Belgium
UZ Antwerpen, UZ Leuven
Nr of subjects
96
Foreseen duration
Q1 2022 to Q4 2023
Current status
Authorized