Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ended
Participants planned
4
Countries
1
Sites
1
Various solid tumors that are metastatic or unresectable
Key facts
- Sponsor
- BioNTech SE
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 4 Oct 2022 → 11 Sep 2025
- Decision date (initial)
- 2024-02-08
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2023-509508-13-00
- EudraCT number
- 2021-005599-20
- ClinicalTrials.gov
- NCT04710043
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Various solid tumors that are metastatic or unresectable
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | LLT | 10025648 | Malignant mast cell tumors unspecified site extranodal and solid organ sites | 10029104 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
BioNTech SE
- Sponsor organisation
- BioNTech SE
- Address
- An Der Goldgrube 12, Oberstadt Oberstadt
- City
- Mainz
- Postcode
- 55131
- Country
- Germany
Scientific contact point
- Organisation
- BioNTech SE
- Contact name
- Clinical Trial Information Desk
Public contact point
- Organisation
- BioNTech SE
- Contact name
- Clinical Trial Information Desk
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Czechia | Ended | 2 | 1 |
| Rest of world
United States
|
— | 2 | — |
Investigational sites
Masarykuv Onkologicky Ustav
Klinika komplexní onkologické péče, Zluty Kopec 543/7, Stare Brno, Brno-Stred
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 |
|---|---|---|---|---|---|
| Czechia | 2022-10-04 | 2025-09-10 | 2022-10-18 | 2025-03-05 |
Application history
4 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-12-14 | Czechia | Acceptable 2024-02-07
|
2024-02-08 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-03-15 | Czechia | Acceptable 2024-06-19
|
2024-06-20 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-07-15 | Czechia | Acceptable 2024-09-13
|
2024-09-16 |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-05-08 | Czechia | Acceptable 2025-08-18
|
2025-08-19 |