Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruiting
Participants planned
604
Countries
3
Sites
11
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
- 8 Aug 2022 → ongoing
- Decision date (initial)
- 2024-06-25
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2024-512822-28-00
- EudraCT number
- 2021-005357-91
- ClinicalTrials.gov
- NCT05238922
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Advanced or metastatic solid tumors
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.0 | LLT | 10048683 | Advanced cancer | 10029104 |
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 Trials Information
Public contact point
- Organisation
- Incyte Corp.
- Contact name
- Clinical Trials Information
Locations
3 EU/EEA countries · 11 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ongoing, recruiting | 50 | 4 |
| Italy | Ongoing, recruiting | 160 | 5 |
| Netherlands | Ended | 25 | 2 |
| Rest of world
United Kingdom, Japan, United States, Switzerland
|
— | 369 | — |
Investigational sites
Institut Bergonie
Medical Oncology, 180 R De Saint Genes, 229 Cours De L Argonne, Bordeaux
Centre Leon Berard
Medical Oncology, 28 Rue Laennec, 69008, Lyon
Institut Universitaire Du Cancer Toulouse-Oncopole
Medical Oncology, 1 Avenue Irene Joliot Curie, 31059, Toulouse Cedex 9
Institut Gustave Roussy
Department of Medicine, 114 Rue Edouard Vaillant, 94800, Villejuif
Humanitas Mirasole S.p.A.
Oncology and Hematology, Via Alessandro Manzoni 56, 20089, Rozzano
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
UOC Fase 1, Largo Agostino Gemelli 8, 00168, Rome
Istituto Nazionale Dei Tumori
Medical Oncology Department, Via Giacomo Venezian 1, 20133, Milan
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Gynecologic Oncology Unit, Largo Agostino Gemelli 8, 00168, Rome
Centro Ricerche Cliniche Di Verona S.r.l.
Oncology, Piazzale Ludovico Antonio Scuro 10, 37134, Verona
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 |
|---|---|---|---|---|---|
| France | 2022-09-26 | 2022-11-10 | |||
| Italy | 2022-10-26 | 2022-11-17 | |||
| Netherlands | 2022-08-08 | 2025-11-10 | 2022-10-27 |
Application history
5 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-05-21 | Italy | Acceptable 2024-06-20
|
2024-06-21 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-08-02 | Italy | Acceptable | 2024-09-09 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-11-29 | Italy | Acceptable 2025-03-12
|
2025-03-12 |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-04-30 | Italy | Acceptable 2025-08-08
|
2025-08-08 |
| 5 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-12-05 | Italy | Acceptable 2026-02-23
|
2026-02-23 |