Clinical trial • Phase I • Oncology
BI 765179 for Advanced head and neck cancer
Phase I trial of BI 765179 for Advanced head and neck cancer. None/Not specified-controlled. 85 participants.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Advanced head and neck cancer
- Trial Stage
- Phase I
- Drug Modality
- Monoclonal antibody|Other
Key dates
- Initial CTIS Submission Date
- 15-02-2024
- First CTIS Authorization Date
- 11-03-2024
Trial design
None/Not specified-controlled Phase I trial across 17 sites in Italy, Belgium, Netherlands and others.
- Comparator
- None/Not specified
- Target Sample Size
- 85
Eligibility
Recruits 85 Vulnerable population selected; no details on consent or assent provided in source..
- Vulnerable Population
- Vulnerable population selected; no details on consent or assent provided in source.
Recruitment
- Planned Sample Size
- 85
- Recruitment Window Months
- 85
Geography
- Total Number Of Sites
- 17
- Total Number Of Participants
- 111
Italy
- Latest Decision Or Authorization Date
- 18-03-2024
- Number Of Sites
- 1
- Number Of Participants
- 5
Sites
- Site Name
- IRCCS Istituto Nazionale Tumori Fondazione Pascale
- Department Name
- Struttura Complessa Oncologia Medica Melanoma
- Principal Investigator Name
- Paolo Ascierto
- Principal Investigator Email
- paolo.ascierto@gmail.com
- Contact Person Name
- Paolo Ascierto
- Contact Person Email
- paolo.ascierto@gmail.com
Belgium
- Latest Decision Or Authorization Date
- 27-03-2024
- Number Of Sites
- 3
- Number Of Participants
- 23
Sites
- Site Name
- Algemeen Ziekenhuis Groeninge
- Department Name
- Oncologisch centrum
- Principal Investigator Name
- Philip Debruyne
- Principal Investigator Email
- philip.debruyne@azgroeninge.be
- Contact Person Name
- Philip Debruyne
- Contact Person Email
- philip.debruyne@azgroeninge.be
- Site Name
- Antwerp University Hospital
- Department Name
- UNICCRA Research Unit Oncology
- Principal Investigator Name
- Marika Rasschaert
- Principal Investigator Email
- marika.rasschaert@uza.be
- Contact Person Name
- Marika Rasschaert
- Contact Person Email
- marika.rasschaert@uza.be
- Site Name
- Cliniques Universitaires Saint-Luc
- Department Name
- Unité d'Oncologie Médicale
- Principal Investigator Name
- Jean Pascal Machiels
- Principal Investigator Email
- jean-pascal.machiels@saintluc.uclouvain.be
- Contact Person Name
- Jean Pascal Machiels
- Contact Person Email
- jean-pascal.machiels@saintluc.uclouvain.be
Netherlands
- Latest Decision Or Authorization Date
- 11-03-2024
- Number Of Sites
- 2
- Number Of Participants
- 30
Sites
- Site Name
- Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
- Department Name
- Interne Oncologie
- Principal Investigator Name
- Ferry Eskens
- Principal Investigator Email
- f.eskens@erasmusmc.nl
- Contact Person Name
- Ferry Eskens
- Contact Person Email
- f.eskens@erasmusmc.nl
- Site Name
- Amsterdam UMC Stichting
- Department Name
- Radiology & Nuclear Medicine
- Principal Investigator Name
- Willemien van der Houven van Oordt
- Principal Investigator Email
- c.menke@vumc.nl
- Contact Person Name
- Willemien van der Houven van Oordt
- Contact Person Email
- c.menke@vumc.nl
Spain
- Latest Decision Or Authorization Date
- 11-03-2024
- Number Of Sites
- 4
- Number Of Participants
- 41
Sites
- Site Name
- Clinica Universidad De Navarra
- Department Name
- Unidad central de Ensayos Clínicos
- Principal Investigator Name
- Ignacio Melero
- Principal Investigator Email
- imelero@unav.es
- Contact Person Name
- Ignacio Melero
- Contact Person Email
- imelero@unav.es
- Site Name
- Hospital Clinico San Carlos
- Department Name
- Servicio de Oncología Médica
- Principal Investigator Name
- Santiago Cabezas
- Principal Investigator Email
- santicc81@gmail.com
- Contact Person Name
- Santiago Cabezas
- Contact Person Email
- santicc81@gmail.com
- Site Name
- Vall D Hebron Institute Of Oncology
- Department Name
- Early Drug Development Unit-UITM
- Principal Investigator Name
- Elena Garralda
- Principal Investigator Email
- egarralda@nextoncology.eu
- Contact Person Name
- Elena Garralda
- Contact Person Email
- egarralda@nextoncology.eu
- Site Name
- Institut Catala D'oncologia
- Department Name
- Institut Català d'oncologia
- Principal Investigator Name
- Neus Bastè
- Principal Investigator Email
- nbaste@iconcologia.net
- Contact Person Name
- Neus Bastè
- Contact Person Email
- nbaste@iconcologia.net
France
- Latest Decision Or Authorization Date
- 10-04-2025
- Number Of Sites
- 3
- Number Of Participants
- 4
Sites
- Site Name
- Centre Hospitalier Universitaire De Bordeaux
- Department Name
- Service d’Oncologie Médicale
- Principal Investigator Name
- Amaury Daste
- Principal Investigator Email
- amaury.daste@chu-bordeaux.fr
- Contact Person Name
- Amaury Daste
- Contact Person Email
- amaury.daste@chu-bordeaux.fr
- Site Name
- Institut De Cancerologie De L Ouest
- Department Name
- Service d'Oncologie Médicale
- Principal Investigator Name
- Frédéric Rolland
- Principal Investigator Email
- frederic.rolland@ico.unicancer.fr
- Contact Person Name
- Frédéric Rolland
- Contact Person Email
- frederic.rolland@ico.unicancer.fr
- Site Name
- Centr Georges Francois Leclerc
- Department Name
- Unité de Phase Précoce
- Principal Investigator Name
- François Ghiringhelli
- Principal Investigator Email
- FGhiringhelli@cgfl.fr
- Contact Person Name
- François Ghiringhelli
- Contact Person Email
- FGhiringhelli@cgfl.fr
Czechia
- Latest Decision Or Authorization Date
- 22-04-2025
- Number Of Sites
- 1
- Number Of Participants
- 2
Sites
- Site Name
- Masarykuv Onkologicky Ustav
- Department Name
- Comprehensive Cancer Care Department
- Principal Investigator Name
- Peter Grell
- Principal Investigator Email
- grell@mou.cz
- Contact Person Name
- Peter Grell
- Contact Person Email
- grell@mou.cz
Germany
- Latest Decision Or Authorization Date
- 10-04-2025
- Number Of Sites
- 3
- Number Of Participants
- 6
Sites
- Site Name
- Medical Center - University Of Freiburg
- Department Name
- Klinik für Tumorbiologie und Innere Medizin I
- Principal Investigator Name
- Justyna Rawluk
- Principal Investigator Email
- justyna.rawluk@uniklinik-freiburg.de
- Contact Person Name
- Justyna Rawluk
- Contact Person Email
- justyna.rawluk@uniklinik-freiburg.de
- Site Name
- Martin-Luther-Universitaet Halle-Wittenberg
- Department Name
- Universitätsmedizin Halle, Klinik für Innere Medizin IV
- Principal Investigator Name
- Christine Dierks
- Principal Investigator Email
- christine.dierks@uk-halle.de
- Contact Person Name
- Christine Dierks
- Contact Person Email
- christine.dierks@uk-halle.de
- Site Name
- Klinikum Der Landeshauptstadt Stuttgart gKAöR
- Department Name
- Klinik für Hämatologie, Onkologie, Stammzelltransplantation und Palliativmedizin
- Principal Investigator Name
- Dennis Hahn
- Principal Investigator Email
- D.Hahn@klinikum-stuttgart.de
- Contact Person Name
- Dennis Hahn
- Contact Person Email
- D.Hahn@klinikum-stuttgart.de
Sponsor
Primary sponsor
- Full Name
- Boehringer Ingelheim International GmbH
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Germany
Third parties
- {"country":"Spain","full_name":"Boehringer Ingelheim Espana S.A.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
Co-sponsors
- Boehringer Ingelheim Espana S.A.
Investigational products
- Investigational Product Name
- BI 765179
- Active Substance
- BI 765179
- Modality
- Other
- Investigational Product Name
- ezabenlimab
- Active Substance
- ezabenlimab
- Modality
- Monoclonal antibody
- Investigational Product Name
- pembrolizumab
- Active Substance
- pembrolizumab
- Modality
- Monoclonal antibody
- Combination Treatment
- Yes
Related trials
Other published trials that may interest you.
- GDC-9545 for Locally advanced or metastatic estrogen receptor-positive breast cancer
- Abemaciclib for Stage IV lung cancer | Breast cancer
- BGB-43395 for Advanced or metastatic solid tumors | Hormone receptor positive HER2 negative breast cancer
- AZD9833 for Estrogen receptor-positive HER2-negative advanced breast cancer
- Pembrolizumab for Classical Hodgkin lymphoma | Melanoma | Solid tumours (MSI-H/dMMR) | Solid tumours (TMB-H)