Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruiting
Participants planned
44
Countries
1
Sites
3
Adrenocortical carcinoma
Key facts
- Sponsor
- Universitaetsklinikum Wuerzburg AöR
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 9 Apr 2025 → ongoing
- Decision date (initial)
- 2024-07-19
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2024-512019-36-00
- EudraCT number
- 2022-003728-41
- WHO UTN
- U1111-1305-9608
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Adrenocortical carcinoma
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10061275 | Mantle cell lymphoma | 100000004864 |
| 20.0 | PT | 10033128 | Ovarian cancer | 100000004864 |
| 20.0 | PT | 10006187 | Breast cancer | 100000004864 |
| 20.0 | PT | 10001388 | Adrenocortical carcinoma | 100000004864 |
| 21.0 | LLT | 10008976 | Chronic lymphocytic leukemia | 10029104 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Universitaetsklinikum Wuerzburg AöR
- Sponsor organisation
- Universitaetsklinikum Wuerzburg AöR
- Address
- Oberduerrbacher Strasse 6, Grombuehl Grombuehl
- City
- Wuerzburg
- Postcode
- 97080
- Country
- Germany
Scientific contact point
- Organisation
- Universitaetsklinikum Wuerzburg AöR
- Contact name
- Sekretariat I
Public contact point
- Organisation
- Universitaetsklinikum Wuerzburg AöR
- Contact name
- Sekretariat I
Locations
1 EU/EEA country · 3 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Germany | Ongoing, recruiting | 44 | 3 |
| Rest of world | — | 0 | — |
Investigational sites
Universitaetsklinikum Wuerzburg AöR
Medizinische Klinik und Poliklinik II, Interdisziplinäres Studienzentrum mit ECTU, Straubmuehlweg 2a, Grombuehl, Wuerzburg
Universitaetsklinikum Koeln AöR
Klinik I für Innere Medizin, Kerpener Strasse 62, Lindenthal, Cologne
Charite Universitaetsmedizin Berlin KöR
CBF, Medizinische Klinik m.S. Hämatologie, Onkologie und Tumorimmunologie, ECTU, Hindenburgdamm 30, Lichterfelde, Berlin
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 | 2025-04-09 | 2025-04-09 |
Application history
4 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-06-11 | Germany | Acceptable 2024-07-09
|
2024-07-19 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-11-29 | Germany | Acceptable 2025-01-23
|
2025-01-27 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2026-02-05 | Germany | Acceptable 2026-04-07
|
2026-04-09 |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2026-04-13 | Germany | Acceptable 2026-04-07
|
2026-04-13 |