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

Study 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
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: 
27 oct 2021
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

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