Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Authorised, recruitment pending
Participants planned
39
Countries
2
Sites
3
Melanoma
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]
- Decision date (initial)
- 2025-11-14
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2025-522045-21-00
- WHO UTN
- U1111-1323-2127
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Melanoma
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 · 3 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Authorised, recruitment pending | 13 | 2 |
| Netherlands | Authorised, recruitment pending | 13 | 1 |
| Rest of world
United States
|
— | 13 | — |
Investigational sites
UZ Leuven
Medical Oncology Department, Herestraat 49, 3000, Leuven
Cliniques Universitaires Saint-Luc
Department of Oncology, route 42, Hippokrateslaan 10, Batiment 54, Sint-Lambrechts-Woluwe
Radboud universitair medisch centrum Stichting
Medical oncology, Geert Grooteplein Zuid 10, 6525 GA, Nijmegen
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-07-18 | Netherlands | Acceptable with conditions 2025-11-10
|
2025-11-14 |