Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Not authorised
Participants planned
20
Countries
1
Sites
1
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]
- Decision date (initial)
- 2023-05-17
- 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 · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Germany | Not authorised | 20 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-02-03 | Germany | Not acceptable 2023-05-15
|
2023-05-17 |