Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruiting
Participants planned
94
Countries
2
Sites
7
Advanced or metastatic carcinomas after previous immune checkpoint blockade therapy
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
- 27 May 2020 → ongoing
- Decision date (initial)
- 2024-03-05
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-510841-32-00
- EudraCT number
- 2019-000613-36
- ClinicalTrials.gov
- NCT04471987
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Advanced or metastatic carcinomas after previous immune checkpoint blockade therapy
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | LLT | 10007284 | Carcinoma | 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
- Jacqueline Mock
Public contact point
- Organisation
- Philogen S.p.A.
- Contact name
- Jacqueline Mock
Locations
2 EU/EEA countries · 7 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Germany | Ongoing, recruiting | 28 | 4 |
| Italy | Ongoing, recruiting | 28 | 3 |
| Rest of world
Switzerland
|
— | 38 | — |
Investigational sites
Universitaetsklinikum Heidelberg AöR
Dermatology and National Center for Tumor Diseases (NCT), Im Neuenheimer Feld 460, Neuenheim, Heidelberg
Universitaetsklinikum Leipzig AöR
Dermatology, Venerology and Allergology, Philipp-Rosenthal-Strasse 27 C, Zentrum-Suedost, Leipzig
University Medical Center Hamburg-Eppendorf
Medicine II, Martinistrasse 52, Eppendorf, Hamburg
Universitaetsklinikum Tuebingen AöR
Innere Medizin VIII, Otfried-Mueller-Strasse 10, Nordstadt, Tuebingen
European Institute Of Oncology S.r.l.
Divisione di Sviluppo di Nuovi Farmaci per Terapie Innovative, Via Giuseppe Ripamonti 435, 20141, Milan
Azienda Ospedaliero-Universitaria San Luigi Gonzaga
Oncologia, Regione Gonzole 10, 10043, Orbassano
Fondazione IRCCS Istituto Nazionale Dei Tumori
Immunoterapia clinica dei tumori e terapie innovative, 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 |
|---|---|---|---|---|---|
| Germany | 2020-07-02 | 2021-02-01 | |||
| Italy | 2020-05-27 | 2020-06-29 |
Application history
4 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-01-25 | Germany | Acceptable 2024-03-05
|
2024-03-05 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-04-12 | Germany | Acceptable 2024-06-17
|
2024-06-21 |
| 3 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-08-08 | Germany | Acceptable 2025-11-17
|
2025-11-19 |
| 4 | SUBSTANTIAL MODIFICATION | SM-4 | 2026-03-10 | Germany | Acceptable 2026-04-27
|
2026-04-29 |