Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruiting
Participants planned
56
Countries
1
Sites
1
Prostate cancer recurrent
Key facts
- Sponsor
- Universitaetsklinikum Tuebingen AöR
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male
- Therapeutic area
- Diseases [C] - Male Urogenital Diseases [C12]
- Trial duration
- 11 Nov 2022 → ongoing
- Decision date (initial)
- 2024-03-05
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-511430-12-00
- EudraCT number
- 2022-002420-13
- ClinicalTrials.gov
- NCT05646550
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Prostate cancer recurrent
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.0 | PT | 10036911 | Prostate cancer recurrent | 100000004864 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Universitaetsklinikum Tuebingen AöR
- Sponsor organisation
- Universitaetsklinikum Tuebingen AöR
- Address
- Geissweg 3, Innenstadt Innenstadt
- City
- Tübingen
- Postcode
- 72076
- Country
- Germany
Scientific contact point
- Organisation
- Universitaetsklinikum Tuebingen AöR
- Contact name
- Helmut Salih
Public contact point
- Organisation
- Universitaetsklinikum Tuebingen AöR
- Contact name
- Helmut Salih
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Germany | Ongoing, recruiting | 56 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
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 |
|---|---|---|---|---|---|
| Germany | 2022-11-11 | 2023-01-10 |
Application history
4 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-02-12 | Germany | Acceptable 2024-02-29
|
2024-03-05 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-02-07 | Germany | Acceptable 2025-03-26
|
2025-03-26 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-11-06 | Germany | Acceptable 2025-03-26
|
2025-11-06 |
| 4 | SUBSTANTIAL MODIFICATION | SM-2 | 2026-03-10 | Germany | Acceptable 2026-04-07
|
2026-04-09 |