Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruiting
Participants planned
98
Countries
3
Sites
13
Advanced or refractory solid tumours (Part 1)
Key facts
- Sponsor
- Deuteroncology
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Not possible to specify
- Trial duration
- 13 Apr 2023 → ongoing
- Decision date (initial)
- 2023-06-15
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2023-504897-39-00
- EudraCT number
- 2022-001681-35
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Advanced or refractory solid tumours (Part 1)
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Deuteroncology
- Sponsor organisation
- Deuteroncology
- Address
- Clos Chanmurly 13
- City
- Liege
- Postcode
- 4000
- Country
- Belgium
Scientific contact point
- Organisation
- Deuteroncology
- Contact name
- Timothy Perera
Public contact point
- Organisation
- Deuteroncology
- Contact name
- Timothy Perera
Locations
3 EU/EEA countries · 13 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ongoing, recruiting | 33 | 4 |
| France | Ongoing, recruiting | 40 | 7 |
| Netherlands | Ongoing, recruiting | 25 | 2 |
| Rest of world | — | 0 | — |
Investigational sites
Antwerp University Hospital
Oncology, Drie Eikenstraat 655, 2650, Edegem
Universitair Ziekenhuis Gent
Medical Oncology Department, Corneel Heymanslaan 10, 9000, Gent
Cliniques Universitaires Saint-Luc
Medical oncology, Hippokrateslaan 10, Batiment 54, Sint-Lambrechts-Woluwe
UZ Leuven
Pneumologie, Herestraat 49, 3000, Leuven
Centre Léon Bérard
Medical Oncology Department, Medical Oncology Department, Rue Laennec 28, Lyon Cedex 08
Hôpitaux Universitaires de Marseille Timone
Multidisciplinary Oncology & Therapeutic Innovations, 264 Rue Saint-Pierre, 13385, Marseille
Centre Antoine Lacassagne
Oncology, 33 Avenue De Valombrose, 06189, Nice Cedex 2
Institut Gustave Roussy
Thoracic department, 114 Rue Edouard Vaillant, 94800, Villejuif
Institut Coeur Poumon - CHU Lille
Service de Pneumologie et Oncologie Thoracique, Service de Pneumologie et Oncologie Thoracique, 2e et 3e étage Nord, Lille Cedex
Centre Hospitalier Universitaire De Rennes
Thoracic department, 2 Rue Henri Le Guilloux, 35000, Rennes
Institut Bergonie
Thoracic program and early phase trials unit, 180 R De Saint Genes, 229 Cours De L Argonne, Bordeaux
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 |
|---|---|---|---|---|---|
| Belgium | 2023-04-13 | 2023-04-13 | |||
| France | 2024-06-06 | 2024-06-06 | |||
| Netherlands | 2023-07-20 | 2023-07-20 |
Application history
7 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-04-03 | Netherlands | Acceptable 2023-05-31
|
2023-05-31 |
| 2 | SUBSEQUENT ADDITION OF MSC | APP-2 | 2023-08-15 | Acceptable 2023-05-31
|
2023-11-13 | |
| 3 | SUBSTANTIAL MODIFICATION | SM-1 | 2023-08-15 | Netherlands | Acceptable | 2023-10-04 |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2023-08-29 | Acceptable | 2023-11-09 | |
| 5 | SUBSTANTIAL MODIFICATION | SM-4 | 2023-12-14 | Netherlands | Acceptable 2024-02-28
|
2024-02-28 |
| 6 | SUBSTANTIAL MODIFICATION | SM-5 | 2025-05-28 | Netherlands | Acceptable with conditions 2025-09-08
|
2025-09-09 |
| 7 | SUBSTANTIAL MODIFICATION | SM-6 | 2025-10-15 | Netherlands | Acceptable 2025-12-12
|
2025-12-12 |