Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruiting
Participants planned
30
Countries
1
Sites
1
Solid tumors
Key facts
- Sponsor
- Thena Biotech S.r.l.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 13 Nov 2024 → ongoing
- Decision date (initial)
- 2024-09-16
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2023-503787-17-00
- WHO UTN
- U1111-1294-9754
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Solid tumors
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | LLT | 10065252 | Solid tumor | 10029104 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Thena Biotech S.r.l.
- Sponsor organisation
- Thena Biotech S.r.l.
- Address
- Via Ufente 20
- City
- Latina
- Postcode
- 04100
- Country
- Italy
Scientific contact point
- Organisation
- Thena Biotech S.r.l.
- Contact name
- Pierpaolo Ceci
Public contact point
- Organisation
- Thena Biotech S.r.l.
- Contact name
- Pierpaolo Ceci
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Italy | Ongoing, recruiting | 30 | 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 |
|---|---|---|---|---|---|
| Italy | 2024-11-13 | 2024-11-13 |
Application history
4 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-05-28 | Italy | Acceptable 2024-09-12
|
2024-09-16 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2025-02-28 | Italy | Acceptable 2024-09-12
|
2025-02-28 |
| 3 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-11-28 | Italy | Acceptable 2026-02-18
|
2026-02-19 |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-4 | 2026-03-20 | Italy | Acceptable 2026-02-18
|
2026-03-20 |