Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ongoing, recruitment ended
Participants planned
20
Countries
4
Sites
7
Glioma expressing DLL3
Key facts
- Sponsor
- Boehringer Ingelheim International GmbH, Boehringer Ingelheim Espana S.A., Boehringer Ingelheim RCV GmbH & Co. KG
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 23 Apr 2024 → ongoing
- Decision date (initial)
- 2024-04-17
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2022-501766-22-01
- WHO UTN
- U1111-1290-7234
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Glioma expressing DLL3
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10018338 | Glioma | 100000004864 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Boehringer Ingelheim International GmbH
- Sponsor organisation
- Boehringer Ingelheim International GmbH
- Address
- Binger Strasse 173
- City
- Ingelheim Am Rhein
- Postcode
- 55216
- Country
- Germany
Scientific contact point
- Organisation
- Boehringer Ingelheim International GmbH
- Contact name
- CT Disclosure & Data Transparency
Public contact point
- Organisation
- Boehringer Ingelheim International GmbH
- Contact name
- CT Disclosure & Data Transparency
Boehringer Ingelheim Espana S.A.
- Sponsor organisation
- Boehringer Ingelheim Espana S.A.
- Address
- Carrer Prat De La Riba 50
- City
- Sant Cugat Del Valles
- Postcode
- 08174
- Country
- Spain
Boehringer Ingelheim RCV GmbH & Co. KG
- Sponsor organisation
- Boehringer Ingelheim RCV GmbH & Co. KG
- Address
- Dr.-Boehringer-Gasse 5-11, Meidling Meidling
- City
- Vienna
- Postcode
- 1120
- Country
- Austria
Locations
4 EU/EEA countries · 7 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Austria | Ongoing, recruitment ended | 1 | 1 |
| Germany | Ended | 4 | 3 |
| Netherlands | Ongoing, recruitment ended | 3 | 1 |
| Spain | Ongoing, recruitment ended | 6 | 2 |
| Rest of world
United States, Switzerland
|
— | 6 | — |
Investigational sites
SCRI CCCIT Ges.m.b.H.
University clinic for internal medicine 3, Muellner Hauptstrasse 48, 5020, Salzburg
Klinikum der Universitaet Muenchen AöR
Neuroonkologisches Zentrum, Comprehensive Cancer Center München, Marchioninistrasse 15, Hadern, Munich
Universitaetsklinikum Tuebingen AöR
Neurologie mit interdisziplinärem Schwerpunkt Neuroonkologie, Hoppe-Seyler-Strasse 3, Nordstadt, Tuebingen
Goethe University Frankfurt
Dr. Senckenbergisches Institut für Neuroonkologie, Zentrum der Neurologie und Neurochirurgie, Theodor-Stern-Kai 7, 60590, Frankfurt Am Main
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Neuro Oncology, Dr. Molewaterplein 40, 3015 GD, Rotterdam
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 |
|---|---|---|---|---|---|
| Austria | 2024-05-08 | 2024-10-07 | 2025-10-07 | ||
| Germany | 2024-04-23 | 2026-01-13 | 2024-06-19 | 2025-10-07 | |
| Netherlands | 2024-05-23 | 2024-06-21 | 2025-10-07 | ||
| Spain | 2024-05-08 | 2024-05-22 | 2025-10-07 |
Application history
5 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-12-01 | Germany | Acceptable 2024-04-12
|
2024-04-16 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-05-31 | Germany | Acceptable 2024-08-05
|
2024-08-08 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-10-21 | Germany | Acceptable 2025-01-08
|
2025-01-08 |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-03-25 | Germany | Acceptable 2025-06-17
|
2025-06-17 |
| 5 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-12-10 | Germany | Acceptable 2026-02-23
|
2026-02-23 |