Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruiting
Participants planned
313
Countries
2
Sites
7
Small Cell Lung Carcinoma and other neuroendocrine neoplasms expressing DLL3
Key facts
- Sponsor
- Boehringer Ingelheim International GmbH
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 15 Jul 2020 → ongoing
- Decision date (initial)
- 2024-09-04
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-513100-34-00
- EudraCT number
- 2019-000729-31
- WHO UTN
- U1111-1307-7553
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Small Cell Lung Carcinoma and other neuroendocrine neoplasms expressing DLL3
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
Locations
2 EU/EEA countries · 7 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Germany | Ongoing, recruiting | 110 | 3 |
| Spain | Ongoing, recruiting | 125 | 4 |
| Rest of world
United States, Japan
|
— | 78 | — |
Investigational sites
Universitaetsklinikum Wuerzburg AöR
Medizinische Klinik und Poliklinik II, Straubmuehlweg 2a, Grombuehl, Wuerzburg
Technische Universitaet Dresden
Early Clinical Trial Unit, Universitätsklinikum Carl Gustav Carus Dresden, Fetscherstrasse 74, Johannstadt-Nord, Dresden
University Hospital Cologne AöR
Klinik I für Innere Medizin, Kerpener Strasse 62, Lindenthal, Cologne
Clinica Universidad De Navarra
Servicio de Oncología Médica, Pio XII Etorbidea 36, 31008, Pamplona
Hospital Del Mar
Servicio de Oncología Médica, Passeig Maritim De La Barceloneta 25-29, 08003, Barcelona
Hospital Universitari Vall D Hebron
Servicio de Oncología Médica, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
Hospital Clinico Universitario De Valencia
Servicio de Oncología Médica, Avenida Blasco Ibanez 17, 46010, Valencia
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 | 2020-07-21 | 2020-10-06 | |||
| Spain | 2020-07-15 | 2020-11-10 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-08-05 | Germany | Acceptable with conditions 2024-09-03
|
2024-09-04 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-10-16 | Germany | Acceptable 2025-01-10
|
2025-01-10 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2026-01-29 | Germany | Acceptable 2026-05-04
|
2026-05-04 |