Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Authorised, recruitment pending
Participants planned
230
Countries
3
Sites
10
Hematological malignancies
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]
- Decision date (initial)
- 2026-06-16
- 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
Hematological malignancies
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
3 EU/EEA countries · 10 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Authorised, recruitment pending | 60 | 4 |
| Denmark | Authorised, recruitment pending | 30 | 2 |
| Italy | Authorised, recruitment pending | 60 | 4 |
| Rest of world
United States, Australia
|
— | 80 | — |
Investigational sites
UZ Leuven
General Medical Oncology, Herestraat 49, 3000, Leuven
Universitair Ziekenhuis Antwerpen
Oncology, Drie Eikenstraat 655, 2650, Edegem
Cliniques Universitaires Saint-Luc
Medical Oncology, Hippokrateslaan 10, Batiment 54, Sint-Lambrechts-Woluwe
Universitair Ziekenhuis Gent
Medical Oncology/Drug Research Unit Ghent, Corneel Heymanslaan 10, 9000, Gent
Rigshospitalet
Department of Haematology, Blegdamsvej 9, 2100, Copenhagen Oe
Region Midtjylland
Department of Hematology, Palle Juul-Jensens Boulevard 99, 8200, Aarhus N
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
UOC Phase 1, Largo Francesco Vito 1, 00168, Rome
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
Department of Oncological and Hematological Diseases, Via Pietro Albertoni 15, 40138, Bologna
Centro Ricerche Cliniche Di Verona S.r.l.
Oncology section, Piazzale Ludovico Antonio Scuro 10, 37134, Verona
Istituto Nazionale Dei Tumori
Oncology and Hematology, Via Giacomo Venezian 1, 20133, Milan
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2026-03-06 | Belgium | Acceptable 2026-06-16
|
2026-06-16 |