Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruiting
Participants planned
185
Countries
4
Sites
15
Advanced or metastatic solid tumors
Key facts
- Sponsor
- Incyte Corp.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 30 Nov 2023 → ongoing
- Decision date (initial)
- 2023-11-07
- 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 or metastatic solid tumors
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Incyte Corp.
- Sponsor organisation
- Incyte Corp.
- Address
- 1801 Augustine Cut Off
- City
- Wilmington
- Postcode
- 19803-4404
- Country
- United States
Scientific contact point
- Organisation
- Incyte Corp.
- Contact name
- Clinical Trial Information
Public contact point
- Organisation
- Incyte Corp.
- Contact name
- Clinical Trial Information
Locations
4 EU/EEA countries · 15 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Denmark | Ongoing, recruiting | 20 | 4 |
| France | Ongoing, recruiting | 15 | 3 |
| Italy | Ongoing, recruiting | 15 | 3 |
| Spain | Ongoing, recruiting | 25 | 5 |
| Rest of world
United States, United Kingdom, Switzerland
|
— | 110 | — |
Investigational sites
Odense University Hospital
Department of Oncology, J B Winsloews Vej 4, 5000, Odense C
Lillebaelt Hospital
Department of Oncology, Beriderbakken 4, 7100, Vejle
Herlev Hospital
Department of Oncology, Borgmester Ib Juuls Vej 1, 2730, Herlev
Rigshospitalet
Department of Oncology, Blegdamsvej 9, 2100, Copenhagen Oe
Institut Paoli-Calmettes
Oncology, 232 Boulevard De Sainte Marguerite, Bp 156, Marseille
Centre Leon Berard
Medical Oncology, 28 Rue Laennec, 69008, Lyon
Institut Gustave Roussy
Cancer Medicine and DITEP, 114 Rue Edouard Vaillant, 94800, Villejuif
Humanitas Research Hospital
Oncology an Hematology operative unit, Via Alessandro Manzoni 56, 20089, Rozzano
Centro Ricerche Cliniche Di Verona S.r.l.
CENTRO RICERCHE CLINICHE DI VERONA s.r.l., Piazzale Ludovico Antonio Scuro 10, 37134, Verona
Fondazione IRCCS Istituto Nazionale Dei Tumori
Immunotherapy and anticancer Innovative Therapeutics Unit, Via Giacomo Venezian 1, 20133, Milan
Hospital Universitario Hm Sanchinarro
Oncology, Calle Ona 10, 28050, Madrid
Hospital Hm Nou Delfos
Oncology, Avinguda De Vallcarca 151, 08023, Barcelona
Hospital Universitari Vall D Hebron
Oncology, Edificio Materno-Infantil, Passeig De La Vall D'hebron 119-129, Barcelona
Hospital Universitario 12 De Octubre
Oncology, Bloque D, Avenida De Cordoba S/n, Madrid
Hospital Universitario Fundacion Jimenez Diaz
Oncology, Avenida De Los Reyes Catolicos 2, 28040, 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 |
|---|---|---|---|---|---|
| Denmark | 2023-11-30 | 2024-01-16 | |||
| France | 2024-01-10 | 2024-01-29 | |||
| Italy | 2023-12-13 | 2024-01-09 | |||
| Spain | 2023-11-30 | 2024-01-10 |
Application history
7 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-07-19 | Denmark | Acceptable 2023-11-06
|
2023-11-07 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-01-12 | Denmark | Acceptable 2023-11-06
|
2024-01-12 |
| 3 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-08-09 | Denmark | Acceptable 2024-10-07
|
2024-10-07 |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2024-12-23 | Acceptable 2024-10-07
|
2024-12-23 | |
| 5 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-02-14 | Denmark | Acceptable 2025-05-14
|
2025-05-14 |
| 6 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-06-20 | Denmark | Acceptable 2025-09-29
|
2025-09-29 |
| 7 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-11-07 | Denmark | Acceptable 2026-02-05
|
2026-02-05 |