Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruitment ended
Participants planned
84
Countries
1
Sites
7
Advanced Solid Tumors
Key facts
- Sponsor
- iTeos Belgium
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 13 Jun 2023 → ongoing
- Decision date (initial)
- 2023-05-08
- 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
Advanced Solid Tumors
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | LLT | 10065252 | Solid tumor | 10029104 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
iTeos Belgium
- Sponsor organisation
- iTeos Belgium
- Address
- Rue Des Freres Wright 29/3
- City
- Charleroi
- Postcode
- 6041
- Country
- Belgium
Scientific contact point
- Organisation
- Iteos Therapeutics
- Contact name
- Iteos Clinical Trial Information
Public contact point
- Organisation
- Iteos Therapeutics
- Contact name
- Iteos Clinical Trial Information
Locations
1 EU/EEA country · 7 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ongoing, recruitment ended | 84 | 7 |
| Rest of world | — | 0 | — |
Investigational sites
Gasthuiszusters Antwerpen
Medical Oncology, Oosterveldlaan 24, 2610, Antwerp
Cliniques Universitaires Saint-Luc
Medical Oncology, Hippokrateslaan 10, Batiment 54, Sint-Lambrechts-Woluwe
Universitair Ziekenhuis Gent
Medical Oncolgy, Corneel Heymanslaan 10, 9000, Gent
Centre hospitalier universitaire de Liege
Medical Oncology, Avenue De L'hopital 1, 4000, Liege
Institut Jules Bordet
Medical Oncology, Mijlenmeersstraat 90, 1070, Brussels
Jessa Ziekenhuis
Medical Oncology, Stadsomvaart 11, 3500, Hasselt
Grand Hopital De Charleroi
Medical Oncology, Rue Du Campus Des Viviers 1, 6060, Charleroi
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 | 2023-06-13 | 2023-07-07 | 2025-07-03 |
Application history
8 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-03-27 | Belgium | Acceptable with conditions 2023-05-03
|
2023-05-08 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2023-05-31 | Belgium | Acceptable 2023-06-09
|
2023-06-19 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2023-10-20 | Belgium | Acceptable 2023-12-12
|
2023-12-18 |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2023-12-22 | Belgium | Acceptable | 2024-02-13 |
| 5 | SUBSTANTIAL MODIFICATION | SM-4 | 2024-05-13 | Belgium | Acceptable with conditions 2024-06-20
|
2024-06-20 |
| 6 | SUBSTANTIAL MODIFICATION | SM-5 | 2024-07-15 | Belgium | Acceptable 2024-08-02
|
2024-08-02 |
| 7 | SUBSTANTIAL MODIFICATION | SM-6 | 2024-12-05 | Belgium | Acceptable 2025-02-07
|
2025-02-07 |
| 8 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-12-26 | Belgium | Acceptable 2025-02-07
|
2025-12-26 |