Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruiting
Participants planned
28
Countries
1
Sites
1
HER2-positive tumors
Key facts
- Sponsor
- Radboud universitair medisch centrum Stichting
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01], Diseases [C] - Neoplasms [C04]
- Trial duration
- 2 Apr 2026 → ongoing
- Decision date (initial)
- 2025-08-07
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2025-520673-39-00
- ClinicalTrials.gov
- NCT07009184
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
HER2-positive tumors
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Radboud universitair medisch centrum Stichting
- Sponsor organisation
- Radboud universitair medisch centrum Stichting
- Address
- Geert Grooteplein Zuid 10
- City
- Nijmegen
- Postcode
- 6525 GA
- Country
- Netherlands
Scientific contact point
- Organisation
- Radboud universitair medisch centrum Stichting
- Contact name
- James Nagarajah
Public contact point
- Organisation
- Radboud universitair medisch centrum Stichting
- Contact name
- Medical Imaging Research Office
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Ongoing, recruiting | 28 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Radboud universitair medisch centrum Stichting
Medical Imaging, Nuclear Medicine, Geert Grooteplein Zuid 10, 6525 GA, Nijmegen
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 |
|---|---|---|---|---|---|
| Netherlands | 2026-04-02 | 2026-04-02 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-05-06 | Netherlands | Acceptable with conditions 2025-08-07
|
2025-08-07 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-08-21 | Netherlands | Acceptable 2025-10-06
|
2025-10-06 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-12-17 | Netherlands | Acceptable 2026-03-23
|
2026-03-25 |