Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Authorised, recruiting
Participants planned
180
Countries
6
Sites
16
Completely Resected Stage IIB, IIC, and III Melanoma
Key facts
- Sponsor
- Celltrion Inc.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Skin and Connective Tissue Diseases [C17]
- Trial duration
- 2 Oct 2024 → ongoing
- Decision date (initial)
- 2024-09-05
- 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
Completely Resected Stage IIB, IIC, and III Melanoma
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Celltrion Inc.
- Sponsor organisation
- Celltrion Inc.
- Address
- 23 Academy-Ro, Yeonsu-Gu Yeonsu-Gu
- City
- Incheon
- Postcode
- 22014
- Country
- Korea, Republic of
Scientific contact point
- Organisation
- Celltrion Inc.
- Contact name
- Clinical Planning
Public contact point
- Organisation
- Celltrion Inc.
- Contact name
- Yelim Jang
Locations
6 EU/EEA countries · 16 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Croatia | Not authorised | 8 | 1 |
| Italy | Ended | 6 | 2 |
| Poland | Ongoing, recruitment ended | 11 | 1 |
| Romania | Ongoing, recruitment ended | 21 | 3 |
| Slovenia | Ended | 7 | 1 |
| Spain | Ongoing, recruitment ended | 30 | 8 |
| Rest of world
Moldova, Republic of, Brazil, South Africa, Ukraine, Georgia, North Macedonia, Albania, Turkey, Peru, Serbia
|
— | 97 | — |
Investigational sites
Azienda Ospedaliera Universitaria Senese
UOC Immonoterapia Oncologica, Strada Delle Scotte 14, 53100, Siena
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.
Oncology Department, Via Piero Maroncelli 40, 47014, Meldola
Uniwersyteckie Centrum Kliniczne
Centrum Wsparcia Badan Klinicznych UCK Osrodek Badan Klinicznych Wczesnych Faz, Ul. Mariana Smoluchowskiego 17, 80-214, Gdansk
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca
Medical Oncology, Strada Republicii 34-36, 400015, Cluj-Napoca
Institutul Oncologic Prof. Dr. Alexandru Trestioreanu Bucuresti
Medical Oncology, Soseaua Fundeni 252, 022328, Bucharest
Centrul De Oncologie SF Nectarie S.R.L.
Oncology, Strada Caracal Nr 109, 200542, Craiova
Institute Of Oncology Ljubljana
Department of Surgical Oncology, Zaloska Cesta 2, 1000, Ljubljana
Hospital Universitario De Torrejon
Oncology, Calle De Mateo Inurria 1, 28850, Torrejon De Ardoz
Hospital Universitari Dexeus Grupo Quironsalud
Medical Oncology, Calle De Sabino Arana 5-19, 08028, Barcelona
Hospital San Pedro De Alcantara
Medical Oncology, Avenida De Pablo Naranjo Porras S/n, 10002, Caceres
Hospital Universitario Marques De Valdecilla
Medical Oncology, Avenida Valdecilla Sn, 39008, Santander
Hospital Universitario 12 De Octubre
Medical Oncology, Bloque D, Avenida De Cordoba Sn, Madrid
Hospital Universitario Virgen De La Victoria
Medical Oncology, Calle Del Arroyo Teatinos Sn, 29010, Malaga
Institut Catala D'oncologia
Oncology, Carretera Canyet S/n, 08916, Badalona
Parc Tauli Hospital Universitari
Oncology, Parc Del Tauli 1 Edifici Santa Fe Ala Izquierda Planta 2ª, 08208, Sabadell
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 | 2024-12-13 | ||||
| Poland | 2024-11-06 | 2025-04-01 | 2025-11-17 | ||
| Romania | 2024-10-02 | 2024-10-24 | 2025-12-10 | ||
| Slovenia | 2024-10-23 | 2025-03-24 | 2025-12-09 | ||
| Spain | 2024-10-14 | 2024-11-06 | 2025-12-10 |
Application history
5 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-05-17 | Spain | Acceptable 2024-08-23
|
2024-08-23 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-09-30 | Spain | Acceptable 2024-11-19
|
2024-11-21 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-02-19 | Spain | Acceptable 2025-04-21
|
2025-04-22 |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-06-24 | Spain | Acceptable 2025-08-19
|
2025-08-21 |
| 5 | SUBSTANTIAL MODIFICATION | SM-6 | 2026-02-11 | Spain | Acceptable 2026-04-07
|
2026-04-13 |