Phase I open-label, dose escalation trial of BI 1831169 monotherapy and in combination with ezabenlimab in patients with advanced or metastatic solid tumors

Study 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
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: 
10 Jan 2022
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.

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