Clinical trial • Phase III • Oncology
BI 765063 for Head and neck squamous cell carcinoma | Hepatocellular carcinoma
Phase III trial of BI 765063 for Head and neck squamous cell carcinoma | Hepatocellular carcinoma. 29 participants.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Head and neck squamous cell carcinoma | Hepatocellular carcinoma
- Trial Stage
- Phase III
- Drug Modality
- Monoclonal antibody|Small molecule|Other
Key dates
- Initial CTIS Submission Date
- 31-05-2024
- First CTIS Authorization Date
- 23-07-2024
Trial design
Phase III trial across 8 sites in France, Romania, Spain.
- Target Sample Size
- 29
Recruitment
- Planned Sample Size
- 29
- Recruitment Window Months
- 41
Geography
- Total Number Of Sites
- 8
- Total Number Of Participants
- 21
France
- Earliest CTIS Part Ii Submission Date
- 21-06-2024
- Latest Decision Or Authorization Date
- 21-08-2024
- Processing Time Days
- 61
- Number Of Sites
- 3
- Number Of Participants
- 10
Sites
- Site Name
- Centr Georges Francois Leclerc
- Department Name
- Oncologie Médicale
- Contact Person Name
- François Ghiringhelli
- Contact Person Email
- FGhiringhelli@cgfl.fr
- Site Name
- Oncopole Claudius Regaud
- Department Name
- IUCT-O
- Contact Person Name
- Carlos Alberto Gomez Roca
- Contact Person Email
- GomezRoca.Carlos@iuct-oncopole.fr
- Site Name
- Institut Curie
- Department Name
- Département Oncologie
- Contact Person Name
- Edith Borcoman
- Contact Person Email
- edith.borcoman@curie.fr
Romania
- Earliest CTIS Part Ii Submission Date
- 21-06-2024
- Latest Decision Or Authorization Date
- 29-07-2024
- Processing Time Days
- 38
- Number Of Sites
- 2
- Number Of Participants
- 2
Sites
- Site Name
- Institutul Oncologic Prof. Dr. Alexandru Trestioreanu Bucuresti
- Department Name
- Oncology
- Contact Person Name
- Laurentia Nicoleta Gales
- Contact Person Email
- Laurentia.gales.ext@arensia-em.com
- Site Name
- Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca
- Department Name
- Department of Oncology
- Contact Person Name
- Tudor Ciuleanu
- Contact Person Email
- tudor_ciuleanu@hotmail.com
Spain
- Earliest CTIS Part Ii Submission Date
- 21-06-2024
- Latest Decision Or Authorization Date
- 23-07-2024
- Processing Time Days
- 32
- Number Of Sites
- 3
- Number Of Participants
- 9
Sites
- Site Name
- Institut Catala D'oncologia
- Department Name
- Institut Català d'Oncologia
- Contact Person Name
- Marta Gil
- Contact Person Email
- mgilmartin@iconcologia.net
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- Oncology Department
- Contact Person Name
- Irene Braña
- Contact Person Email
- ibrana@vhio.net
- Site Name
- Hospital Clinico San Carlos
- Department Name
- Servicio de Oncología Médica
- Contact Person Name
- Javier Sastre
- Contact Person Email
- jsastrev@salud.madrid.org
Sponsor
Primary sponsor
- Full Name
- Boehringer Ingelheim International GmbH
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Germany
Investigational products
- Investigational Product Name
- BI 765063
- Active Substance
- BI 765063
- Modality
- Other
- Investigational Product Name
- ezabenlimab
- Active Substance
- ezabenlimab
- Modality
- Monoclonal antibody
- Investigational Product Name
- chemotherapy
- Active Substance
- chemotherapy
- Modality
- Small molecule
- Investigational Product Name
- cetuximab
- Active Substance
- cetuximab
- Modality
- Monoclonal antibody
- Investigational Product Name
- BI 836880
- Active Substance
- BI 836880
- Modality
- Other
- Combination Treatment
- Yes
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