Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
15
Countries
1
Sites
1
Melanoma, SCCHN
Key facts
- Sponsor
- TILT Biotherapeutics Oy
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 4 Dec 2024 → 11 Mar 2026
- Decision date (initial)
- 2024-12-04
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-518088-37-01
- EudraCT number
- 2021-005127-20
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Melanoma, SCCHN
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
TILT Biotherapeutics Oy
- Sponsor organisation
- TILT Biotherapeutics Oy
- Address
- Tukholmankatu 8b
- City
- Helsinki
- Postcode
- 00290
- Country
- Finland
Scientific contact point
- Organisation
- TILT Biotherapeutics Oy
- Contact name
- Suvi Sorsa
Public contact point
- Organisation
- TILT Biotherapeutics Oy
- Contact name
- Suvi Sorsa
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Finland | Ended | 9 | 1 |
| Rest of world
United States
|
— | 6 | — |
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 | 2024-12-04 | 2024-12-04 | 2025-12-17 |
Application history
4 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-11-20 | Finland | Acceptable 2024-12-03
|
2024-12-04 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-12-10 | Finland | Acceptable 2024-12-03
|
2024-12-10 |
| 3 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-04-16 | Finland | Acceptable 2025-07-02
|
2025-07-03 |
| 4 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-10-20 | Finland | Acceptable 2025-12-08
|
2025-12-10 |