Overview
Sponsor-declared trial summary
Phase
Phase I and Phase II (Integrated) - First administration to humans
Status
Ongoing, recruiting
Participants planned
44
Countries
1
Sites
2
Prostate Cancer
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
- 15 Nov 2019 → ongoing
- Decision date (initial)
- 2024-04-12
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-512894-29-00
- EudraCT number
- 2019-000238-20
- ClinicalTrials.gov
- NCT04104607
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Prostate Cancer
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | LLT | 10036910 | Prostate cancer NOS | 10029104 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Universitaetsklinikum Tuebingen AöR
- Sponsor organisation
- Universitaetsklinikum Tuebingen AöR
- Address
- Geissweg 3, Innenstadt Innenstadt
- City
- Tuebingen
- Postcode
- 72076
- Country
- Germany
Scientific contact point
- Organisation
- Universitaetsklinikum Tuebingen AöR
- Contact name
- KKE Translationale Immunologie
Public contact point
- Organisation
- Universitaetsklinikum Tuebingen AöR
- Contact name
- KKE Translationale Immunologie
Locations
1 EU/EEA country · 2 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Germany | Ongoing, recruiting | 44 | 2 |
| 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 | 2019-11-15 | 2019-11-18 |
Application history
4 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-03-21 | Germany | Acceptable 2024-04-04
|
2024-04-12 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-08-13 | Germany | Acceptable 2025-10-13
|
2025-10-16 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-11-03 | Germany | Acceptable 2025-10-13
|
2025-11-03 |
| 4 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-12-03 | Germany | Acceptable 2026-02-06
|
2026-02-11 |