Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruiting
Participants planned
182
Countries
5
Sites
16
Advanced metastatic castration-resistant prostate cancer with prostate specific membrane antigen (PSMA) expression
Key facts
- Sponsor
- Bayer Consumer Care AG
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 20 Aug 2024 → ongoing
- Decision date (initial)
- 2024-01-30
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2023-507486-26-00
- ClinicalTrials.gov
- NCT06217822
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Advanced metastatic castration-resistant prostate cancer with prostate specific membrane antigen (PSMA) expression
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | LLT | 10076506 | Castration-resistant prostate cancer | 10029104 |
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
Locations
5 EU/EEA countries · 16 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ongoing, recruiting | 20 | 3 |
| Finland | Ongoing, recruiting | 20 | 5 |
| Italy | Ongoing, recruiting | 10 | 2 |
| Netherlands | Ongoing, recruiting | 10 | 2 |
| Sweden | Ongoing, recruiting | 13 | 4 |
| Rest of world
Canada, Switzerland, United States, United Kingdom
|
— | 109 | — |
Investigational sites
Algemeen Ziekenhuis Groeninge
Urology, President Kennedylaan 4, 8500, Kortrijk
UZ Leuven
Nuclear Medicine, Herestraat 49, 3000, Leuven
Institut Jules Bordet
Nuclear Medicine, Mijlenmeersstraat 90, 1070, Anderlecht
HUS-yhtymae
Helsinki University Hospital Comprehensive cancer center, Clinical trial unit, Haartmaninkatu 4, 00290, Helsinki
Pohjois-Savon hyvinvointialue
Department of Oncology, Kelkkailijantie 7, Puijonlaaksontie 2, P. O. Box 1711, Kuopio
Turku University Hospital
Oncology department, Kiinamyllynkatu 4-8, 20520, Turku
Tampere University Hospital
Oncology and radiotherapy department, Elamanaukio 2, 33520, Tampere
Mehilaeinen Oy
Docrates Mehiläinen cancer center, Saukonpaadenranta 2, 00180, Helsinki
IRCCS Istituto Nazionale Tumori Fondazione Pascale
Nuclear Medicine, Via Mariano Semmola 52, 80131, Naples
Istituto Europeo Di Oncologia S.r.l.
Nuclear Medicine, Via Giuseppe Ripamonti 435, 20141, Milan
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Medical Oncology, Dr. Molewaterplein 40, 3015 GD, Rotterdam
Universitair Medisch Centrum Groningen
Medical Oncology, Hanzeplein 1, 9713 GZ, Groningen
Karolinska University Hospital
Fas 1-enheten Solna, CKC, Tema Cancer, Eugeniavagen 3, 171 64, Solna
Uppsala University Hospital
KFUE, Blod och tumörsjukdomar, Akademiska Sjukhuset, Uppsala, Akademiska Sjukhuset, 751 85, Uppsala
Sahlgrenska University Hospital-Vaestra Goetalandsregionen
Verksamhet onkologi, Bla Straket 5, 413 46 Goteborg, Bla Straket 5, Goteborgs Annedal, Goteborg
Region Skane Skanes Universitetssjukhus
KFE Hematologi, onkologi och strålningsfysik, Lasarettsgatan 23, 221 85 Lund, Entregatan 7, 222 42, Lund
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 | 2024-08-20 | 2024-09-24 | |||
| Finland | 2025-12-11 | 2025-12-12 | |||
| Italy | 2025-10-31 | 2025-12-15 | |||
| Netherlands | 2025-12-29 | 2026-02-03 | |||
| Sweden | 2025-10-22 | 2025-10-27 |
Application history
19 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-11-30 | Belgium | Acceptable 2024-01-25
|
2024-01-30 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-06-05 | Belgium | Acceptable 2024-06-20
|
2024-07-11 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-08-06 | Belgium | Acceptable | 2024-08-19 |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-11-05 | Belgium | Acceptable | 2024-11-05 |
| 5 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-11-19 | Belgium | Acceptable 2024-12-18
|
2024-12-18 |
| 6 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-02-19 | Belgium | Acceptable 2025-02-28
|
2025-02-28 |
| 7 | SUBSEQUENT ADDITION OF MSC | APP-7 | 2025-03-17 | Acceptable 2025-02-28
|
2025-06-05 | |
| 8 | SUBSEQUENT ADDITION OF MSC | APP-8 | 2025-03-18 | Acceptable 2025-02-28
|
2025-05-30 | |
| 9 | SUBSEQUENT ADDITION OF MSC | APP-9 | 2025-03-18 | 2025-06-16 | ||
| 10 | SUBSEQUENT ADDITION OF MSC | APP-10 | 2025-03-19 | Acceptable 2025-02-28
|
2025-05-14 | |
| 11 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-06-16 | Belgium | Acceptable 2025-02-28
|
2025-06-16 |
| 12 | SUBSTANTIAL MODIFICATION | SM-5 | 2025-06-18 | Belgium | Acceptable 2025-09-02
|
2025-09-02 |
| 13 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2025-09-05 | Belgium | Acceptable 2025-09-02
|
2025-09-05 |
| 14 | NON SUBSTANTIAL MODIFICATION | NSM-4 | 2025-09-12 | Belgium | Acceptable 2025-09-02
|
2025-09-12 |
| 15 | SUBSTANTIAL MODIFICATION | SM-6 | 2025-09-15 | Belgium | Acceptable | 2025-10-21 |
| 16 | SUBSTANTIAL MODIFICATION | SM-7 | 2025-09-23 | Acceptable | 2025-10-24 | |
| 17 | NON SUBSTANTIAL MODIFICATION | NSM-5 | 2025-10-24 | Acceptable | 2025-10-24 | |
| 18 | SUBSTANTIAL MODIFICATION | SM-8 | 2025-12-12 | Belgium | Acceptable 2026-03-09
|
2026-03-09 |
| 19 | NON SUBSTANTIAL MODIFICATION | NSM-6 | 2026-03-24 | Belgium | Acceptable 2026-03-09
|
2026-03-24 |