Overview
Sponsor-declared trial summary
Phase
Phase I and Phase II (Integrated) - First administration to humans
Status
Ongoing, recruitment ended
Participants planned
18
Countries
1
Sites
1
glioblastoma
Key facts
- Sponsor
- UZ Brussel
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 5 Apr 2024 → ongoing
- Decision date (initial)
- 2024-03-18
- 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
glioblastoma
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10018337 | Glioblastoma multiforme | 100000004864 |
| 20.0 | PT | 10018336 | Glioblastoma | 100000004864 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
UZ Brussel
- Sponsor organisation
- UZ Brussel
- Address
- Laarbeeklaan 101
- City
- Jette
- Postcode
- 1090
- Country
- Belgium
Scientific contact point
- Organisation
- UZ Brussel
- Contact name
- Bart Neyns
Public contact point
- Organisation
- UZ Brussel
- Contact name
- Loes De Koster
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ongoing, recruitment ended | 18 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
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 | 2024-04-05 | 2024-04-10 | 2026-01-01 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-12-04 | Belgium | Acceptable with conditions 2024-03-18
|
2024-03-18 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-04-04 | Belgium | Acceptable 2025-06-03
|
2025-06-03 |