Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ended
Participants planned
72
Countries
3
Sites
3
Metastatic melanoma
Key facts
- Sponsor
- Biontech US Inc.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 1 Dec 2020 → 27 Mar 2025
- Decision date (initial)
- 2023-12-22
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2023-508524-35-00
- EudraCT number
- 2019-003908-13
- ClinicalTrials.gov
- NCT04625205
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Metastatic melanoma
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | LLT | 10027481 | Metastatic melanoma | 10029104 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Biontech US Inc.
- Sponsor organisation
- Biontech US Inc.
- Address
- 40 Erie Street Ste 110
- City
- Cambridge
- Postcode
- 02139-4254
- Country
- United States
Scientific contact point
- Organisation
- Biontech US Inc.
- Contact name
- Clinical Trial Information Desk
Public contact point
- Organisation
- Biontech US Inc.
- Contact name
- Clinical Trial Information Desk
Locations
3 EU/EEA countries · 3 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ended | 15 | 1 |
| Netherlands | Ended | 42 | 1 |
| Spain | Ended | 15 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Netherlands Cancer Institute
Division of Medical Oncology, Division of Molecular Oncology & Immunology, 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 |
|---|---|---|---|---|---|
| Belgium | 2023-11-02 | 2024-06-26 | 2024-10-14 | ||
| Netherlands | 2020-12-01 | 2020-12-01 | 2024-10-14 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-11-20 | Netherlands | Acceptable 2023-12-19
|
2023-12-19 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-06-12 | Netherlands | Acceptable 2024-09-16
|
2024-09-16 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-10-02 | 2024-11-18 |