Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ended
Participants planned
113
Countries
1
Sites
5
Cutaneous Squamous Cell Carcinoma
Key facts
- Sponsor
- Regeneron Pharmaceuticals Inc.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 20 Mar 2025 → 11 Dec 2025
- Decision date (initial)
- 2024-09-05
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2024-511440-76-00
- ClinicalTrials.gov
- NCT03889912
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Cutaneous Squamous Cell Carcinoma
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10004146 | Basal cell carcinoma | 100000004864 |
| 24.1 | LLT | 10085908 | Cutaneous squamous cell carcinoma | 100000004848 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Regeneron Pharmaceuticals Inc.
- Sponsor organisation
- Regeneron Pharmaceuticals Inc.
- Address
- 777 Old Saw Mill River Road
- City
- Tarrytown
- Postcode
- 10591-6717
- Country
- United States
Scientific contact point
- Organisation
- Regeneron Pharmaceuticals Inc.
- Contact name
- Medical Affairs
Public contact point
- Organisation
- Regeneron Pharmaceuticals Inc.
- Contact name
- Medical Affairs
Locations
1 EU/EEA country · 5 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Ended | 5 | 5 |
| Rest of world
United States, Australia
|
— | 108 | — |
Investigational sites
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Dept. Dermatology, Dr. Molewaterplein 40, 3015 GD, Rotterdam
Academisch Ziekenhuis Maastricht
Dept. Dermatology, P Debyelaan 25, 6229 HX, Maastricht
Universitair Medisch Centrum Groningen
Dept. Dermatology, Hanzeplein 1, 9713 GZ, Groningen
Radboud universitair medisch centrum Stichting
Dept. Dermatology, Geert Grooteplein Zuid 10, 6525 GA, Nijmegen
Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting
Dept. Dermatology, Plesmanlaan 121, 1066 CX, Amsterdam
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 |
|---|---|---|---|---|---|
| Netherlands | 2025-03-20 | 2025-12-10 | 2025-05-15 | 2025-06-26 |
Application history
4 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-06-05 | Netherlands | Acceptable 2024-09-05
|
2024-09-05 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-09-25 | Netherlands | Acceptable | 2024-10-17 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-01-31 | Netherlands | Acceptable 2025-03-12
|
2025-03-12 |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-08-06 | Netherlands | Acceptable 2025-03-12
|
2025-08-06 |