Clinical trial • Phase I • Oncology
BI 1831169 for Solid tumors
Phase I trial of BI 1831169 for Solid tumors. None/Not specified-controlled, adaptive. 64 participants.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Solid tumors
- Trial Stage
- Phase I
- Drug Modality
- Small molecule | Monoclonal antibody
Key dates
- Initial CTIS Submission Date
- 31-05-2024
- First CTIS Authorization Date
- 23-07-2024
Trial design
None/Not specified-controlled, adaptive Phase I trial across 22 sites in Belgium, Germany, Austria and others.
- Comparator
- None/Not specified
- Adaptive
- True, dose-escalation elements testing different dose levels (protocol references to "lower dose levels" ongoing)
- Single Multiple Or Escalation Dose Combined
- Yes
- Target Sample Size
- 64
Recruitment
- Planned Sample Size
- 64
- Recruitment Window Months
- 61
Geography
- Total Number Of Sites
- 22
- Total Number Of Participants
- 122
Belgium
- Latest Decision Or Authorization Date
- 22-09-2025
- Number Of Sites
- 3
- Number Of Participants
- 16
Sites
- Site Name
- Antwerp University Hospital
- Department Name
- Oncologie UZA
- Principal Investigator Name
- Hans Prenen
- Principal Investigator Email
- Hans.Prenen@uza.be
- Contact Person Name
- Hans Prenen
- Contact Person Email
- Hans.Prenen@uza.be
- Site Name
- Universitair Ziekenhuis Gent
- Department Name
- Medical Oncology
- Principal Investigator Name
- Sylvie Rottey
- Principal Investigator Email
- sylvie.rottey@uzgent.be
- Contact Person Name
- Sylvie Rottey
- Contact Person Email
- sylvie.rottey@uzgent.be
- Site Name
- UZ Leuven
- Department Name
- General Medical Oncology
- Principal Investigator Name
- Oliver Bechter
- Principal Investigator Email
- oliver.bechter@uzleuven.be
- Contact Person Name
- Oliver Bechter
- Contact Person Email
- oliver.bechter@uzleuven.be
Germany
- Latest Decision Or Authorization Date
- 24-09-2025
- Number Of Sites
- 4
- Number Of Participants
- 22
Sites
- Site Name
- Universitaetsklinikum Heidelberg AöR
- Department Name
- Service d'Oncologie Multidisciplinaire et Innovation thérapeutique
- Principal Investigator Name
- Guy Ungerechts
- Principal Investigator Email
- guy.ungerechts@nct-heidelberg.de
- Contact Person Name
- Guy Ungerechts
- Contact Person Email
- guy.ungerechts@nct-heidelberg.de
- Site Name
- Universitaetsklinikum Ulm AöR
- Department Name
- Comprehensive Cancer Center Ulm (CCCU)
- Principal Investigator Name
- Christof Schneider
- Principal Investigator Email
- christof.schneider@uniklinik-ulm.de
- Contact Person Name
- Christof Schneider
- Contact Person Email
- christof.schneider@uniklinik-ulm.de
- Site Name
- Charite Universitaetsmedizin Berlin KöR
- Department Name
- Charité Comprehensive Cancer Center
- Principal Investigator Name
- Sebastian Ochsenreither
- Principal Investigator Email
- sebastian.ochsenreither@charite.de
- Contact Person Name
- Sebastian Ochsenreither
- Contact Person Email
- sebastian.ochsenreither@charite.de
- Site Name
- Universitaetsklinikum Tuebingen AöR
- Department Name
- Medizinische Klinik Innere Medizin VIII
- Principal Investigator Name
- Ulrich Lauer
- Principal Investigator Email
- ulrich.lauer@uni-tuebingen.de
- Contact Person Name
- Ulrich Lauer
- Contact Person Email
- ulrich.lauer@uni-tuebingen.de
Austria
- Latest Decision Or Authorization Date
- 23-09-2025
- Number Of Sites
- 2
- Number Of Participants
- 10
Sites
- Site Name
- SCRI CCCIT Ges.m.b.H.
- Department Name
- Center for Clinical Cancer and Immunology Trials (CCCIT)
- Principal Investigator Name
- Alexander Egle
- Principal Investigator Email
- a.egle@salk.at
- Contact Person Name
- Alexander Egle
- Contact Person Email
- a.egle@salk.at
- Site Name
- Medizinische Universitaet Innsbruck
- Department Name
- Univ.-Klinik für Innere Medizin V, Hämatologie und Onkologie
- Principal Investigator Name
- Dominik Wolf
- Principal Investigator Email
- dominik.wolf@i-med.ac.at
- Contact Person Name
- Dominik Wolf
- Contact Person Email
- dominik.wolf@i-med.ac.at
France
- Latest Decision Or Authorization Date
- 10-11-2025
- Number Of Sites
- 5
- Number Of Participants
- 42
Sites
- Site Name
- Institut Gustave Roussy
- Department Name
- Département d'Innovation Thérapeutique et d’Essais Précoces - DITEP
- Principal Investigator Name
- Rastislav Bahleda
- Principal Investigator Email
- Rastilav.BAHLEDA@gustaveroussy.fr
- Contact Person Name
- Rastislav Bahleda
- Contact Person Email
- Rastilav.BAHLEDA@gustaveroussy.fr
- Site Name
- Centre Hospitalier Regional De Marseille
- Department Name
- Unité de Phase I Oncologie labélisée CLIP
- Principal Investigator Name
- Laurent Greillier
- Principal Investigator Email
- Laurent.GREILLIER@ap-hm.fr
- Contact Person Name
- Laurent Greillier
- Contact Person Email
- Laurent.GREILLIER@ap-hm.fr
- Site Name
- Institut Bergonie
- Department Name
- Service Oncologie
- Principal Investigator Name
- Antoine Italiano
- Principal Investigator Email
- a.italiano@bordeaux.unicancer.fr
- Contact Person Name
- Antoine Italiano
- Contact Person Email
- a.italiano@bordeaux.unicancer.fr
- Site Name
- Centre De Lutte Contre Le Cancer Eugene Marquis
- Department Name
- Département d'Oncologie Médicale
- Principal Investigator Name
- Héloise Bourien
- Principal Investigator Email
- h.bourien@rennes.unicancer.fr
- Contact Person Name
- Héloise Bourien
- Contact Person Email
- h.bourien@rennes.unicancer.fr
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- Service Dermatologie
- Principal Investigator Name
- Celeste Lebbe
- Principal Investigator Email
- celeste.lebbe@aphp.fr
- Contact Person Name
- Celeste Lebbe
- Contact Person Email
- celeste.lebbe@aphp.fr
Spain
- Latest Decision Or Authorization Date
- 28-10-2025
- Number Of Sites
- 5
- Number Of Participants
- 25
Sites
- Site Name
- Hospital Universitario Fundacion Jimenez Diaz
- Department Name
- Servicio de Oncología Médica
- Principal Investigator Name
- Víctor Moreno
- Principal Investigator Email
- victor.moreno@startmadrid.com
- Contact Person Name
- Víctor Moreno
- Contact Person Email
- victor.moreno@startmadrid.com
- Site Name
- Hospital Quironsalud Barcelona
- Department Name
- Next Oncology Barcelona IOB
- Principal Investigator Name
- Guzmán Alonso
- Principal Investigator Email
- galonso@nextoncology.eu
- Contact Person Name
- Guzmán Alonso
- Contact Person Email
- galonso@nextoncology.eu
- Site Name
- Clinica Universidad De Navarra
- Department Name
- Servicio de Oncología Médica
- Principal Investigator Name
- Mariano Ponz
- Principal Investigator Email
- mponz@unav.es
- Contact Person Name
- Mariano Ponz
- Contact Person Email
- mponz@unav.es
- Site Name
- Fundacion Instituto Valenciano De Oncologia
- Department Name
- Servicio de Farmacia
- Principal Investigator Name
- David Lorente
- Principal Investigator Email
- dlorente@fivo.org
- Contact Person Name
- David Lorente
- Contact Person Email
- dlorente@fivo.org
- Site Name
- Institut Catala D'oncologia
- Department Name
- Servicio de Oncología Médica
- Principal Investigator Name
- Ramon Salazar Soler
- Principal Investigator Email
- ramonsalazar@iconcologia.net
- Contact Person Name
- Ramon Salazar Soler
- Contact Person Email
- ramonsalazar@iconcologia.net
Italy
- Latest Decision Or Authorization Date
- 27-11-2025
- Number Of Sites
- 3
- Number Of Participants
- 7
Sites
- Site Name
- Centro Ricerche Cliniche Di Verona S.r.l.
- Department Name
- Azienda Ospedaliera Universitaria Integrata Verona
- Principal Investigator Name
- Andrea Zivi
- Principal Investigator Email
- andrea.zivi@aovr.veneto.it
- Contact Person Name
- Andrea Zivi
- Contact Person Email
- andrea.zivi@aovr.veneto.it
- Site Name
- ASST Grande Ospedale Metropolitano Niguarda
- Department Name
- S.C. Divisione Oncologia Medica Falck
- Principal Investigator Name
- Salvatore Siena
- Principal Investigator Email
- salvatore.siena@ospedaleniguarda.it
- Contact Person Name
- Salvatore Siena
- Contact Person Email
- salvatore.siena@ospedaleniguarda.it
- Site Name
- Istituto Di Candiolo Fondazione Del Piemonte Per L'Oncologia IRCCS
- Department Name
- Trapianti e Terapia cellulare
- Principal Investigator Name
- Fabrizio Carnevale Schianca
- Principal Investigator Email
- fabrizio.carnevale@ircc.it
- Contact Person Name
- Fabrizio Carnevale Schianca
- Contact Person Email
- fabrizio.carnevale@ircc.it
Sponsor
Primary sponsor
- Full Name
- Boehringer Ingelheim International GmbH
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Germany
Investigational products
- Investigational Product Name
- BI 1831169
- Modality
- Small molecule
- Investigational Product Name
- Ezabenlimab (anti-PD-1 antibody)
- Modality
- Monoclonal antibody
- Combination Treatment
- Yes
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