Overview
Sponsor-declared trial summary
Phase
Phase I and Phase II (Integrated) - Other
Status
Ongoing, recruitment ended
Participants planned
100
Countries
2
Sites
6
Locally advanced or metastatic cancer (Solid tumors)
Key facts
- Sponsor
- Byondis B.V.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 22 May 2025 → ongoing
- Decision date (initial)
- 2025-05-05
- 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
Locally advanced or metastatic cancer (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
Byondis B.V.
- Sponsor organisation
- Byondis B.V.
- Address
- Microweg 22
- City
- Nijmegen
- Postcode
- 6545 CM
- Country
- Netherlands
Scientific contact point
- Organisation
- Byondis B.V.
- Contact name
- Clinical Development
Public contact point
- Organisation
- Byondis B.V.
- Contact name
- Clinical Development
Locations
2 EU/EEA countries · 6 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ended | 30 | 2 |
| Spain | Ongoing, recruitment ended | 33 | 4 |
| Rest of world
United Kingdom
|
— | 37 | — |
Investigational sites
UZ Leuven
Medical Oncology, Herestraat 49, 3000, Leuven
Institut Jules Bordet
Medical Oncology, Mijlenmeersstraat 90, 1070, Anderlecht
Institut Catala D'oncologia
Medical Oncology, Avinguda De La Gran Via De L'hospitalet 199-203, 08908, L'hospitalet De Llobregat
Hospital Universitari Vall D Hebron
Medical Oncology, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
Hospital Universitario Fundacion Jimenez Diaz
Medical Oncology, Avenida De Los Reyes Catolicos 2, 28040, Madrid
Hospital Universitario Hm Sanchinarro
Medical Oncology, Calle Ona 10, 28050, Madrid
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 | 2025-06-13 | 2026-03-11 | 2025-08-18 | 2025-10-06 | |
| Spain | 2025-05-22 | 2025-06-02 | 2025-10-06 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-01-27 | Spain | Acceptable 2025-04-30
|
2025-04-30 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-06-17 | Spain | Acceptable 2025-04-30
|
2025-06-17 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2026-04-10 | Spain | Acceptable 2025-04-30
|
2026-04-10 |