Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Authorised, recruitment pending
Participants planned
39
Countries
1
Sites
2
Solid Tumors
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]
- Decision date (initial)
- 2024-12-20
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-520258-39-00
- EudraCT number
- 2020-001778-31
- ClinicalTrials.gov
- NCT04695327
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Solid Tumors
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
- Claudia Kistler
Public contact point
- Organisation
- TILT Biotherapeutics Oy
- Contact name
- Claudia Kistler
Locations
1 EU/EEA country · 2 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Finland | Authorised, recruitment pending | 39 | 2 |
| Rest of world | — | 0 | — |
Investigational sites
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-12-16 | Finland | Acceptable 2024-12-20
|
2024-12-20 |