B/BE/21/BVW7 - Information sheet for the public (prepared by the notifier)Public information according to the provisions of Directive 2001/18/EC
Long title
Phase I open-label, dose escalation trial of BI 1831169 monotherapy and in combination with ezabenlimab in patients with advanced or metastatic solid tumors
Date receipt dossier
EU record number
B/BE/21/BVW7
EudraCT number
2020-003902-30
Company / Sponsor
SCS Boehringer Ingelheim Comm.V
Phase
I
Treated organism
Humans
Indication category
Cancer therapy
Disease
Metastatic or relapsed/recurrent malignant solid tumors
Therapeutic approach
Immunotherapy
Genetic modification
BI 1831169 is a recombinant live-attenuated Vesicular Stomatitis Virus (rVSV), modified to replace the VSV-G glycoprotein with the Lymphocytic Choriomeningitis Virus glycoprotein in order to minimize the potential of neurotoxicity for humans and skin disease in animals.
Method of transfer of nucleic acid of interest
recombinant live-attenuated Vesicular Stomatitis Virus
Administered biological material
Genetically modified virus
Route of administration
intravenous (infusion)/intratumoral (injection)
Locations in Belgium
Cliniques Universitaires Saint-Luc
Nr of subjects
4 patients
Foreseen duration
In Belgium: Q2 2022 - Q1 2025
Type of procedure
Contained use and Deliberate release
Current status
Assessed
Notes
This application was assessed and authorized under the GMO legislation (Royal Decree of 21 February 2005), without prejudice to other applicable legislation.