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Full notification Final report - General information Notification Number B/ES/22/12 Member State to which the notification was sent Spain Date of acknowledgement from the Member State Competent Authority 16/06/2022 Title of the Project Phase I open-label, dose escalation trial of BI 1831169 monotherapy and in combination with ezabenlimab in patients with advanced or metastatic solid tumors Proposed period of release: 01/10/2022 to 30/06/2025 Name of the Institute(s) or Company(ies) Boehringer Ingelheim, España, S.A
Is the same GMO been notified elsewhere by the same notifier? Yes:
Austria; Belgium; Germany; France; Has the same GMO been notified elsewhere by the same notifier? No GMO characterization GMO is a: RNA Virus Identity of the GMO: Genus: Vesiculovirus Species: Vesicular stomatitis virus Information relating to the recipient or parental organisms from which the GMO is derived Common Name: Genus: Vesiculovirus Species: Vesicular stomatitis virus Subspecies: Strain: Indiana Pathovar: VSV European Commission administrative Information Consent given by the Member State Competent Authority: Not known