Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Authorised, recruiting
Participants planned
232
Countries
4
Sites
13
Metastatic castration-resistant prostate cancer
Key facts
- Sponsor
- Bayer AG
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 18 Sep 2023 → ongoing
- Decision date (initial)
- 2023-07-12
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2022-502623-22-00
- ClinicalTrials.gov
- NCT06052306
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Metastatic castration-resistant prostate cancer
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | PT | 10036909 | Prostate cancer metastatic | 100000004864 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Bayer AG
- Sponsor organisation
- Bayer AG
- City
- Leverkusen
- Postcode
- 51368
- Country
- Germany
Scientific contact point
- Organisation
- Bayer AG
- Contact name
- Therapeutic Area Head
Public contact point
- Organisation
- Bayer AG
- Contact name
- Therapeutic Area Head
Locations
4 EU/EEA countries · 13 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Finland | Ongoing, recruitment ended | 45 | 5 |
| Italy | Authorised, recruitment pending | 8 | 2 |
| Netherlands | Ongoing, recruitment ended | 25 | 2 |
| Sweden | Authorised, recruitment pending | 12 | 4 |
| Rest of world
Switzerland, Canada, United Kingdom, United States
|
— | 142 | — |
Investigational sites
HUS-yhtymae
Clinical Trial Unit, Comprehensive cancer centre, Haartmaninkatu 4, 00290, Helsinki
Tampere University Hospital
Department of Oncology, Elamanaukio 2, 33520, Tampere
Pohjois-Savon hyvinvointialue
Department of Oncology, Puijonlaaksontie 2, P. O. Box 1711, Kuopio
Clinical Research Services Turku CRST Oy
Department of Oncology and Radiotherapy Turku University Hospital, Joukahaisenkatu 2 B, 20520, Turku
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
Sahlgrenska University Hospital-Vaestra Goetalandsregionen
Verksamhet onkologi, Bla Straket 5, 413 46 Goteborg, Bla Straket 5, Goteborgs Annedal, Goteborg
Uppsala University Hospital
KFUE, Blod och tumörsjukdomar, Akademiska Sjukhuset, Uppsala, Akademiska Sjukhuset, 751 85, Uppsala
Karolinska University Hospital
Fas 1-enheten Solna, CKC, Tema Cancer, Eugeniavagen 3, 171 64, Solna
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 |
|---|---|---|---|---|---|
| Finland | 2023-09-18 | 2023-09-20 | 2025-11-19 | ||
| Netherlands | 2024-06-13 | 2024-08-16 | 2025-11-19 |
Application history
26 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-04-13 | Finland | Acceptable 2023-07-03
|
2023-07-12 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2023-07-13 | Finland | Acceptable 2023-07-03
|
2023-07-13 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2023-07-14 | Finland | Acceptable 2023-07-03
|
2023-07-14 |
| 4 | SUBSTANTIAL MODIFICATION | SM-1 | 2023-07-14 | Finland | Acceptable 2023-08-21
|
2023-08-21 |
| 5 | SUBSEQUENT ADDITION OF MSC | APP-5 | 2023-08-24 | Acceptable 2023-08-21
|
2023-11-10 | |
| 6 | SUBSTANTIAL MODIFICATION | SM-2 | 2023-10-04 | Finland | Acceptable | 2023-11-06 |
| 7 | SUBSTANTIAL MODIFICATION | SM-3 | 2023-11-22 | Finland | Acceptable 2024-01-11
|
2024-01-12 |
| 8 | SUBSTANTIAL MODIFICATION | SM-4 | 2024-05-06 | Acceptable | 2024-05-24 | |
| 9 | SUBSTANTIAL MODIFICATION | SM-5 | 2024-06-20 | Finland | Acceptable 2024-08-05
|
2024-08-08 |
| 10 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2024-10-09 | Finland | Acceptable 2024-08-05
|
2024-10-09 |
| 11 | SUBSTANTIAL MODIFICATION | SM-6 | 2024-11-14 | Finland | Acceptable 2024-12-30
|
2025-01-03 |
| 12 | NON SUBSTANTIAL MODIFICATION | NSM-4 | 2025-02-06 | Finland | Acceptable 2024-12-30
|
2025-02-06 |
| 13 | SUBSTANTIAL MODIFICATION | SM-7 | 2025-02-27 | Finland | Acceptable | 2025-04-14 |
| 14 | SUBSEQUENT ADDITION OF MSC | APP-14 | 2025-02-28 | Acceptable 2024-12-30
|
2025-05-14 | |
| 15 | SUBSEQUENT ADDITION OF MSC | APP-15 | 2025-03-04 | Acceptable 2024-12-30
|
2025-05-27 | |
| 16 | NON SUBSTANTIAL MODIFICATION | NSM-5 | 2025-06-05 | Finland | Acceptable 2024-12-30
|
2025-06-05 |
| 17 | SUBSTANTIAL MODIFICATION | SM-8 | 2025-06-11 | Finland | Acceptable 2025-09-10
|
2025-09-10 |
| 18 | NON SUBSTANTIAL MODIFICATION | NSM-6 | 2025-09-11 | Finland | Acceptable 2025-09-10
|
2025-09-11 |
| 19 | NON SUBSTANTIAL MODIFICATION | NSM-7 | 2025-09-11 | Finland | Acceptable 2025-09-10
|
2025-09-11 |
| 20 | SUBSTANTIAL MODIFICATION | SM-9 | 2025-09-18 | Finland | Acceptable | 2025-10-30 |
| 21 | SUBSTANTIAL MODIFICATION | SM-10 | 2025-10-31 | Finland | Acceptable 2026-01-19
|
2026-01-20 |
| 22 | NON SUBSTANTIAL MODIFICATION | NSM-8 | 2026-03-27 | Finland | Acceptable 2026-01-19
|
2026-03-27 |
| 23 | SUBSTANTIAL MODIFICATION | SM-11 | 2026-04-01 | |||
| 24 | SUBSTANTIAL MODIFICATION | SM-12 | 2026-04-21 | Finland | Acceptable | 2026-05-25 |
| 25 | SUBSTANTIAL MODIFICATION | SM-13 | 2026-04-21 | Acceptable | 2026-05-12 | |
| 26 | NON SUBSTANTIAL MODIFICATION | NSM-9 | 2026-05-29 | Finland | Acceptable 2026-01-19
|
2026-05-29 |