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
Contact Person Name
Renaud Lhommel
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

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
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

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

Related trials

Other published trials that may interest you.