Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ended
Participants planned
20
Countries
1
Sites
3
Patients with suspected clear cell renal cell carcinoma (ccRCC)
Key facts
- Sponsor
- Philogen S.p.A.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 19 Mar 2025 → 28 Nov 2025
- Decision date (initial)
- 2024-11-27
- 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
Patients with suspected clear cell renal cell carcinoma (ccRCC)
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Philogen S.p.A.
- Sponsor organisation
- Philogen S.p.A.
- Address
- Piazza La Lizza 7
- City
- Siena
- Postcode
- 53100
- Country
- Italy
Scientific contact point
- Organisation
- Philogen S.p.A.
- Contact name
- Jackeline Mock
Public contact point
- Organisation
- Philogen S.p.A.
- Contact name
- Jacqueline Mock
Locations
1 EU/EEA country · 3 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Italy | Ended | 20 | 3 |
| Rest of world | — | 0 | — |
Investigational sites
Ospedale San Raffaele S.r.l.
Medicina Nucleare, Via Olgettina 60, 20132, Milan
Azienda Socio Sanitaria Territoriale Papa Giovanni Xxiii
Department of Medicine and Surgery and Nuclear Medicine, Piazza Oms 1, 24127, Bergamo
Fondazione IRCCS Istituto Nazionale Dei Tumori
Nuclear Medicine Physician, Via Giacomo Venezian 1, 20133, Milan
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 | 2025-03-19 | 2025-11-28 | 2025-04-16 | 2025-11-19 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-08-09 | Italy | Acceptable 2024-11-25
|
2024-11-27 |