Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ended
Participants planned
6
Countries
1
Sites
1
EGFR-Positive Head and Neck Squamous Cell Carcinoma
Key facts
- Sponsor
- Tenboron Oy
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 5 Jan 2024 → 1 Dec 2025
- Decision date (initial)
- 2024-10-22
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-517779-19-00
- EudraCT number
- 2019-000273-22
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
EGFR-Positive Head and Neck Squamous Cell Carcinoma
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 26.1 | PT | 10060121 | Squamous cell carcinoma of head and neck | 100000004864 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Tenboron Oy
- Sponsor organisation
- Tenboron Oy
- Address
- Viikinkaari 6
- City
- Helsinki
- Postcode
- 00790
- Country
- Finland
Scientific contact point
- Organisation
- Tenboron Oy
- Contact name
- Chief Executive Officer
Public contact point
- Organisation
- Tenboron Oy
- Contact name
- Main office
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Finland | Ended | 6 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
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 |
|---|---|---|---|---|---|
| Finland | 2024-01-05 | 2024-04-10 |
Application history
4 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-10-10 | Finland | Acceptable 2024-10-22
|
2024-10-22 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-02-19 | Finland | Acceptable 2025-03-24
|
2025-03-25 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-04-29 | Finland | Acceptable 2025-07-07
|
2025-07-07 |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-09-18 | Finland | Acceptable 2025-10-02
|
2025-10-02 |