Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruiting
Participants planned
60
Countries
2
Sites
7
Advanced solid tumors
Key facts
- Sponsor
- Italfarmaco 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
- 29 Nov 2022 → ongoing
- Decision date (initial)
- 2022-11-09
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Advanced 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
Italfarmaco S.p.A.
- Sponsor organisation
- Italfarmaco S.p.A.
- Address
- Via Dei Lavoratori 54
- City
- Cinisello Balsamo
- Postcode
- 20092
- Country
- Italy
Scientific contact point
- Organisation
- Italfarmaco S.p.A.
- Contact name
- Maurizio Caserini
Public contact point
- Organisation
- Italfarmaco S.p.A.
- Contact name
- Maurizio Caserini
Locations
2 EU/EEA countries · 7 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Italy | Ongoing, recruiting | 26 | 3 |
| Spain | Ongoing, recruiting | 34 | 4 |
| Rest of world | — | 0 | — |
Investigational sites
Humanitas Research Hospital
Medical Oncology Unit, Humanitas Cancer Center, Via Alessandro Manzoni 56, 20089, Rozzano
IRCCS Istituto Nazionale Tumori - Fondazione Pascale
Melanoma, Cancer Immunotherapy and Development Therapeutics Unit, Via Mariano Semmola 53, 80131, Naples
European Institute Of Oncology S.r.l.
Divisione di Sviluppo di Nuovi Farmaci per Terapie Innovative, Via Giuseppe Ripamonti 435, 20141, Milan
Hospital Universitari Vall D Hebron
Medical Oncology, Passeig De La Vall D Hebron 119-129, 08035, Barcelona
Hospital Quironsalud Barcelona
Oncology, Placa D'alfonso Comin 5-7, 08023, Barcelona
Hospital Universitario Fundacion Jimenez Diaz
Oncology, Avenida De Los Reyes Catolicos 2, 28040, Madrid
University Clinic Of Navarra
Oncology, Calle Marquesado De Santa Marta 1, 28027, Madrid
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 | 2022-12-20 | 2022-12-28 | |||
| Spain | 2022-11-29 | 2022-12-15 |
Application history
12 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2022-07-27 | Spain | Acceptable 2022-11-07
|
2022-11-09 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2023-05-24 | Spain | Acceptable 2022-11-07
|
2023-05-24 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2023-08-30 | Spain | Acceptable 2022-11-07
|
2023-08-30 |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2023-10-11 | Spain | Acceptable 2022-11-07
|
2023-10-11 |
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-4 | 2023-11-17 | Spain | Acceptable 2022-11-07
|
2023-11-17 |
| 6 | NON SUBSTANTIAL MODIFICATION | NSM-5 | 2024-01-08 | Spain | Acceptable 2022-11-07
|
2024-01-08 |
| 7 | NON SUBSTANTIAL MODIFICATION | NSM-6 | 2024-04-19 | Spain | Acceptable 2022-11-07
|
2024-04-19 |
| 8 | NON SUBSTANTIAL MODIFICATION | NSM-7 | 2024-07-31 | Spain | Acceptable 2022-11-07
|
2024-07-31 |
| 9 | NON SUBSTANTIAL MODIFICATION | NSM-8 | 2025-02-28 | Spain | Acceptable 2022-11-07
|
2025-02-28 |
| 10 | NON SUBSTANTIAL MODIFICATION | NSM-9 | 2025-06-19 | Spain | Acceptable 2022-11-07
|
2025-06-19 |
| 11 | NON SUBSTANTIAL MODIFICATION | NSM-10 | 2025-07-31 | Spain | Acceptable 2022-11-07
|
2025-07-31 |
| 12 | NON SUBSTANTIAL MODIFICATION | NSM-11 | 2025-11-26 | Spain | Acceptable 2022-11-07
|
2025-11-26 |