Overview
Sponsor-declared trial summary
Advanced solid tumors, specifically: • metastatic clear cell renal carcinoma • proficient mismatch repair / microsatellite stable (pMMR/MSS), BRAF-V600E-mutant negative colorectal carcinoma • locally advanced or metastatic pancreatic adenocarcinoma
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]
- Decision date (initial)
- 2025-12-22
- 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
Advanced solid tumors, specifically: • metastatic clear cell renal carcinoma • proficient mismatch repair / microsatellite stable (pMMR/MSS), BRAF-V600E-mutant negative colorectal carcinoma • locally advanced or metastatic pancreatic adenocarcinoma
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 28.0 | LLT | 10007116 | Cancer of skin (excl melanoma) | 10029104 |
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
- Claudio Nanni
Public contact point
- Organisation
- Philogen S.p.A.
- Contact name
- Federica Bastioli
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Italy | Authorised, recruitment pending | 96 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-08-08 | Italy | Acceptable 2025-12-18
|
2025-12-22 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2026-01-30 | Italy | Acceptable 2026-04-16
|
2026-04-20 |