Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruiting
Participants planned
235
Countries
4
Sites
14
hepatocellular carcinoma (HCC)
Key facts
- Sponsor
- Bayer Consumer Care AG, Bayer AG
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 14 May 2025 → ongoing
- Decision date (initial)
- 2025-04-08
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
hepatocellular carcinoma (HCC)
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10073071 | Hepatocellular carcinoma | 100000004864 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Bayer Consumer Care AG
- Sponsor organisation
- Bayer Consumer Care AG
- Address
- Peter Merian-Strasse 84
- City
- Basel
- Postcode
- 4052
- Country
- Switzerland
Scientific contact point
- Organisation
- Bayer AG
- Contact name
- Therapeutic Area Head
Public contact point
- Organisation
- Bayer AG
- Contact name
- Therapeutic Area Head
Bayer AG
- Sponsor organisation
- Bayer AG
- Address
- -
- City
- Leverkusen
- Postcode
- 51368
- Country
- Germany
Locations
4 EU/EEA countries · 14 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ongoing, recruiting | 50 | 4 |
| Finland | Ongoing, recruiting | 12 | 2 |
| France | Authorised, recruiting | 40 | 4 |
| Spain | Ongoing, recruiting | 21 | 4 |
| Rest of world
United States, United Kingdom, China, Canada, Japan
|
— | 112 | — |
Investigational sites
Cliniques Universitaires Saint-Luc
Nuclear Medicine, Hippokrateslaan 10, Batiment 54, Sint-Lambrechts-Woluwe
Algemeen Ziekenhuis Groeninge
Digestive Oncology, President Kennedylaan 4, 8500, Kortrijk
UZ Leuven
Digestive Oncology, Herestraat 49, 3000, Leuven
Universitair Ziekenhuis Antwerpen
Digestive Oncology, Drie Eikenstraat 655, 2650, Edegem
Turku University Hospital
Tyks Cancer Centre, Kiinamyllynkatu 4-8, 20520, Turku
Tampere University Hospital
TAYS Cancer Centre, Elamanaukio 2, 33520, Tampere
Centre Hospitalier Universitaire De Nantes
Médecine Nucléaire, 1 Place Alexis Ricordeau, 44000, Nantes
Institut Gustave Roussy
DITEP Drug Development Department, 114 Rue Edouard Vaillant, 94800, Villejuif
Institut Regional Du Cancer De Montpellier
Médecine Nucléaire, 208 Avenue Des Apothicaires, 34298, Montpellier Cedex 5
Hospices Civils De Lyon
Médecine Nucléaire, 28 Avenue Du Doyen Jean Lepine, 69500, Bron
Clinica Universidad De Navarra
Oncology, Calle Marquesado De Santa Marta 1, 28027, Madrid
Clinica Universidad De Navarra
Oncology, Pio XII Etorbidea 36, 31008, Pamplona
Hospital Universitario Hm Sanchinarro
Oncology, Calle Ona 10, 28050, Madrid
Institut Catala D'oncologia
Oncology, Avinguda De La Gran Via De L'hospitalet 199-203, 08908, L'hospitalet De Llobregat
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Belgium | 2025-05-19 | 2025-05-27 | |||
| Finland | 2025-05-14 | 2025-06-05 | |||
| France | 2026-05-26 | ||||
| Spain | 2025-06-18 | 2025-06-27 |
Application history
8 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-12-05 | Finland | Acceptable 2025-04-08
|
2025-04-08 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-04-16 | Acceptable 2025-04-08
|
2025-04-16 | |
| 3 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-04-23 | Finland | Acceptable 2025-07-09
|
2025-07-11 |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-08-01 | Finland | Acceptable 2025-07-09
|
2025-08-01 |
| 5 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-08-04 | Acceptable | 2025-09-11 | |
| 6 | SUBSEQUENT ADDITION OF MSC | APP-6 | 2025-08-06 | Acceptable 2025-07-09
|
2025-10-31 | |
| 7 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-11-12 | Finland | Acceptable 2026-02-11
|
2026-02-11 |
| 8 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2026-02-25 | Finland | Acceptable 2026-02-11
|
2026-02-25 |