Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ended
Participants planned
44
Countries
4
Sites
11
Metastatic Melanoma
Key facts
- Sponsor
- Sairopa B.V.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- completed 24 Feb 2025
- Decision date (initial)
- 2024-06-21
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2024-511949-19-00
- EudraCT number
- 2021-002623-38
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Metastatic Melanoma
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | LLT | 10027481 | Metastatic melanoma | 10029104 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Sairopa B.V.
- Sponsor organisation
- Sairopa B.V.
- Address
- Unit A4 4, Stationsplein 45 Stationsplein 45
- City
- Rotterdam
- Postcode
- 3013 AK
- Country
- Netherlands
Scientific contact point
- Organisation
- Sairopa B.V.
- Contact name
- Laura Lassouw
Public contact point
- Organisation
- Sairopa B.V.
- Contact name
- Laura Lassouw
Locations
4 EU/EEA countries · 11 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ended | 3 | 3 |
| Italy | Ended | 12 | 4 |
| Poland | Ended | 17 | 1 |
| Spain | Ended | 12 | 3 |
| Rest of world | — | 0 | — |
Investigational sites
Institut Gustave Roussy
Dermato-Oncology, 114 Rue Edouard Vaillant, 94800, Villejuif
Centre Hospitalier Regional De Marseille
Dermatology and skin cancer Unit, 264 Rue Saint Pierre, 13005, Marseille
Hopital Saint Louis
Service Dermatologie, 1 Avenue Claude Vellefaux, 75010, Paris
IRCCS Istituto Nazionale Tumori Fondazione Pascale
Oncology, Via Mariano Semmola 52, 80131, Naples
Istituto Europeo Di Oncologia S.r.l.
Oncology, Via Giuseppe Ripamonti 435, 20141, Milan
Istituto Oncologico Veneto
Oncology, Via Gattamelata 64, 35128, Padova
Azienda Ospedaliera Universitaria Senese
Immunoterapia Oncologica, Viale Mario Bracci 2, 53100, Siena
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
Oddział Badań Wczesnych Faz, Ul. Wilhelma Konrada Roentgena 5, 02-781, Warsaw
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-04-30 | Spain | Acceptable 2024-06-18
|
2024-06-18 |
| 2 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-08-28 | Acceptable | 2024-10-01 | |
| 3 | SUBSTANTIAL MODIFICATION | SM-4 | 2024-12-20 | Spain | Acceptable 2025-03-04
|
2025-03-04 |