Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruiting
Participants planned
56
Countries
1
Sites
4
Patients with advanced/metastatic FAP-positive tumors
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
- 11 Jun 2025 → ongoing
- Decision date (initial)
- 2024-09-18
- 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 advanced/metastatic FAP-positive tumors
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | SOC | 10029104 | Neoplasms benign malignant and unspecified (incl cysts and polyps) | 2 |
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
- Jacqueline Mock
Public contact point
- Organisation
- Philogen S.p.A.
- Contact name
- Jacqueline Mock
Locations
1 EU/EEA country · 4 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Italy | Ongoing, recruiting | 56 | 4 |
| Rest of world | — | 0 | — |
Investigational sites
IRCCS Istituto Nazionale Tumori Fondazione Pascale
Medicina Nucleare, Via Mariano Semmola 52, 80131, Naples
Fondazione IRCCS Istituto Nazionale Dei Tumori
Diagnostic Imaging and Radiotherapy/Nuclear Medicine, Via Giacomo Venezian 1, 20133, Milan
Istituto Europeo Di Oncologia S.r.l.
Divisione di Sviluppo di Nuovi Farmaci per Terapie Innovative, Via Giuseppe Ripamonti 435, 20141, Milan
Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII
Department of Medicine and Surgery, Piazza Oms 1, 24127, Bergamo
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 | 2025-06-11 | 2025-10-31 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-05-25 | Italy | Acceptable 2024-09-16
|
2024-09-18 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-04-16 | Italy | Acceptable 2025-06-09
|
2025-06-20 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-12-11 | Italy | Acceptable 2026-01-19
|
2026-02-10 |