Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ongoing, recruiting
Participants planned
9
Countries
1
Sites
1
Melanoma
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
- 31 Mar 2025 → ongoing
- Decision date (initial)
- 2024-09-05
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Melanoma
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
- Trial Team
Public contact point
- Organisation
- TILT Biotherapeutics Oy
- Contact name
- Trial Team
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Denmark | Ongoing, recruiting | 9 | 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 |
|---|---|---|---|---|---|
| Denmark | 2025-03-31 | 2025-06-25 |
Application history
5 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-06-11 | Denmark | Acceptable 2024-09-02
|
2024-09-05 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-12-17 | Denmark | Acceptable 2025-02-12
|
2025-02-13 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-05-04 | Denmark | Acceptable 2025-06-02
|
2025-06-03 |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-10-20 | Denmark | Acceptable 2025-11-27
|
2025-11-27 |
| 5 | SUBSTANTIAL MODIFICATION | SM-4 | 2026-01-30 | Denmark | Acceptable 2026-02-20
|
2026-02-23 |