A Phase I/II, Multicenter, Open-Label Study of Nous-209 Genetic Vaccine for the Treatment of Microsatellite Unstable Solid Tumors

Study title: 
A Phase I/II, Multicenter, Open-Label Study of Nous-209 Genetic Vaccine for the Treatment of Microsatellite Unstable Solid Tumors
Long title: 
A Phase I/II, Multicenter, Open-Label Study of Nous-209 Genetic Vaccine for the Treatment of Microsatellite Unstable Solid Tumors
Date receipt dossier: 
7 okt 2022
EU record number: 
B/BE/22/BVW4
EudraCT number: 
2021-002823-40
Company / Sponsor: 
Nouscom Srl
Phase: 
I/II
Treated organism: 
Humans
Indication category: 
Cancer therapy
Disease: 
Microsatellite Unstable Solid Tumors
Therapeutic approach: 
Immunotherapy
Genetic modification: 
The study involves two GMOs: (i) A replication-incompetent adenovirus (GAd20 with deletions of the viral E1, E3 and E4 coding regions) isolated from a gorilla and encoding the FSP neoantigens; (ii) an attenuated, replication-defective orthopoxvirus (Modified Vaccinia virus Ankara), encoding for the same neoantigens.
Method of transfer of nucleic acid of interest: 
Non-replicating recombinant viruses
Administered biological material: 
Genetically modified viruses
Route of administration: 
Intramuscular
Locations in Belgium: 
Cliniques Universitaires Saint-Luc - Bruxelles
Nr of subjects: 
Up to 115 patients overall and 15 patients in Belgium
Foreseen duration: 
Start: October 2022 – End: December 2024
Type of procedure: 
Contained use and Deliberate release
Current status: 
Authorized

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