Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruiting
Participants planned
20
Countries
1
Sites
3
tumor entities carrying the oncogenic driver fusion DNAJB1-PRKACA
Key facts
- Sponsor
- Universitaetsklinikum Tuebingen
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Digestive System Diseases [C06]
- Trial duration
- 26 Sep 2023 → ongoing
- Decision date (initial)
- 2023-08-29
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
tumor entities carrying the oncogenic driver fusion DNAJB1-PRKACA
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Universitaetsklinikum Tuebingen
- Sponsor organisation
- Universitaetsklinikum Tuebingen
- Address
- Geissweg 3, Innenstadt Innenstadt
- City
- Tübingen
- Postcode
- 72076
- Country
- Germany
Scientific contact point
- Organisation
- Universitaetsklinikum Tuebingen
- Contact name
- Prof. Dr. Helmut Salih
Public contact point
- Organisation
- Universitaetsklinikum Tuebingen
- Contact name
- Prof. Dr. Helmut Salih
Locations
1 EU/EEA country · 3 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Germany | Ongoing, recruiting | 20 | 3 |
| 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 | 2023-09-26 | 2023-10-06 |
Application history
6 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-06-26 | Germany | Acceptable 2023-08-24
|
2023-08-29 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2023-09-28 | Germany | Acceptable | 2023-11-03 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-03-10 | Germany | Acceptable | 2025-03-10 |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2025-03-10 | Germany | Acceptable | 2025-03-10 |
| 5 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-03-25 | Germany | Acceptable 2025-06-04
|
2025-06-05 |
| 6 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-09-10 | Germany | Acceptable 2025-10-07
|
2025-10-14 |