Clinical trial • Phase I • Oncology
BAY 3547926 for Hepatocellular carcinoma
Phase I trial of BAY 3547926 for Hepatocellular carcinoma. open-label. 112 participants.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Hepatocellular carcinoma
- Trial Stage
- Phase I
Key dates
- Initial CTIS Submission Date
- 05-12-2024
- First CTIS Authorization Date
- 08-04-2025
Trial design
open-label Phase I trial across 14 sites in Belgium, Finland, Spain and others.
- Open Label
- Yes
- Target Sample Size
- 112
Recruitment
- Planned Sample Size
- 112
- Recruitment Window Months
- 46
Geography
- Total Number Of Sites
- 14
- Total Number Of Participants
- 123
Belgium
- Earliest CTIS Part Ii Submission Date
- 17-03-2025
- Latest Decision Or Authorization Date
- 11-02-2026
- Processing Time Days
- 331
- Number Of Sites
- 4
- Number Of Participants
- 50
Sites
- Site Name
- UZ Leuven
- Department Name
- Digestive Oncology
- Principal Investigator Name
- Jeroen Dekervel
- Principal Investigator Email
- jeroen.dekervel@uzleuven.be
- Contact Person Name
- Jeroen Dekervel
- Contact Person Email
- jeroen.dekervel@uzleuven.be
- Site Name
- Universitair Ziekenhuis Antwerpen
- Department Name
- Digestive Oncology
- Principal Investigator Name
- Timon Vandamme
- Principal Investigator Email
- Studies.oncologie@uza.be
- Contact Person Name
- Timon Vandamme
- Contact Person Email
- Studies.oncologie@uza.be
- Site Name
- Cliniques Universitaires Saint-Luc
- Department Name
- Nuclear Medicine
- Principal Investigator Name
- Renaud Lhommel
- Principal Investigator Email
- Administration-phase1-clinicaltrialsIRAII@saintluc.uclouvain.be
- Contact Person Name
- Renaud Lhommel
- Contact Person Email
- Administration-phase1-clinicaltrialsIRAII@saintluc.uclouvain.be
- Site Name
- Algemeen Ziekenhuis Groeninge
- Department Name
- Digestive Oncology
- Principal Investigator Name
- Alexander Vanden Bulcke
- Principal Investigator Email
- inwendigeziekten@azgroeninge.be
- Contact Person Name
- Alexander Vanden Bulcke
- Contact Person Email
- inwendigeziekten@azgroeninge.be
Finland
- Earliest CTIS Part Ii Submission Date
- 17-03-2025
- Latest Decision Or Authorization Date
- 16-02-2026
- Processing Time Days
- 336
- Number Of Sites
- 2
- Number Of Participants
- 12
Sites
- Site Name
- Tampere University Hospital
- Department Name
- TAYS Cancer Centre
- Principal Investigator Name
- Minna Tanner
- Principal Investigator Email
- minna.tanner@pirha.fi
- Contact Person Name
- Minna Tanner
- Contact Person Email
- minna.tanner@pirha.fi
- Site Name
- Turku University Hospital
- Department Name
- Tyks Cancer Centre
- Principal Investigator Name
- Saana Virtanen
- Principal Investigator Email
- saana.maaria.virtanen@varha.fi
- Contact Person Name
- Saana Virtanen
- Contact Person Email
- saana.maaria.virtanen@varha.fi
Spain
- Earliest CTIS Part Ii Submission Date
- 04-04-2025
- Latest Decision Or Authorization Date
- 16-02-2026
- Processing Time Days
- 318
- Number Of Sites
- 4
- Number Of Participants
- 21
Sites
- Site Name
- Hospital Universitario Hm Sanchinarro
- Department Name
- Oncology
- Principal Investigator Name
- Irene Moreno Candilejo
- Principal Investigator Email
- irene.moreno@startmadrid.com
- Contact Person Name
- Irene Moreno Candilejo
- Contact Person Email
- irene.moreno@startmadrid.com
- Site Name
- Institut Catala D'oncologia
- Department Name
- Oncology
- Principal Investigator Name
- Mariola Calvo Campos
- Principal Investigator Email
- mcalvo@iconcologia.net
- Contact Person Name
- Mariola Calvo Campos
- Contact Person Email
- mcalvo@iconcologia.net
- Site Name
- Clinica Universidad De Navarra
- Department Name
- Oncology
- Principal Investigator Name
- Bruno Sangro
- Principal Investigator Email
- bsangro@unav.es
- Contact Person Name
- Bruno Sangro
- Contact Person Email
- bsangro@unav.es
- Site Name
- Clinica Universidad De Navarra
- Department Name
- Oncology
- Principal Investigator Name
- Bruno Sangro
- Principal Investigator Email
- bsangro@unav.es
- Contact Person Name
- Bruno Sangro
- Contact Person Email
- bsangro@unav.es
France
- Earliest CTIS Part Ii Submission Date
- 26-09-2025
- Latest Decision Or Authorization Date
- 16-02-2026
- Processing Time Days
- 143
- Number Of Sites
- 4
- Number Of Participants
- 40
Sites
- Site Name
- Institut Regional Du Cancer De Montpellier
- Department Name
- Médecine Nucléaire
- Principal Investigator Name
- Emmanuel Deshayes
- Principal Investigator Email
- emmanuel.deshayes@icm.unicancer.fr
- Contact Person Name
- Emmanuel Deshayes
- Contact Person Email
- emmanuel.deshayes@icm.unicancer.fr
- Site Name
- Centre Hospitalier Universitaire De Nantes
- Department Name
- Médecine Nucléaire
- Principal Investigator Name
- Clément Bailly
- Principal Investigator Email
- clement.bailly@chu-nantes.fr
- Contact Person Name
- Clément Bailly
- Contact Person Email
- clement.bailly@chu-nantes.fr
- Site Name
- Hospices Civils De Lyon
- Department Name
- Médecine Nucléaire
- Principal Investigator Name
- Anthime Flaus
- Principal Investigator Email
- anthime.flaus@chu-lyon.fr
- Contact Person Name
- Anthime Flaus
- Contact Person Email
- anthime.flaus@chu-lyon.fr
- Site Name
- Institut Gustave Roussy
- Department Name
- DITEP Drug Development Department
- Principal Investigator Name
- Antoine Hollebecque
- Principal Investigator Email
- antoine.hollebecque@gustaveroussy.fr
- Contact Person Name
- Antoine Hollebecque
- Contact Person Email
- antoine.hollebecque@gustaveroussy.fr
Sponsor
Primary sponsor
- Full Name
- Bayer Consumer Care AG
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Switzerland
Co-sponsors
- Bayer AG
Investigational products
- Investigational Product Name
- BAY 3547926
- First In Human
- Yes
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