Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruiting
Participants planned
83
Countries
1
Sites
4
metastatic solid cancer, muscle invasive bladder cancer, localized or locally advanced renal cell cancer (RCC)
Key facts
- Sponsor
- CimCure B.V.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 2 Apr 2026 → ongoing
- Decision date (initial)
- 2026-01-29
- 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
metastatic solid cancer, muscle invasive bladder cancer, localized or locally advanced renal cell cancer (RCC)
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
CimCure B.V.
- Sponsor organisation
- CimCure B.V.
- Address
- Plesmanlaan 125
- City
- Amsterdam
- Postcode
- 1066 CX
- Country
- Netherlands
Scientific contact point
- Organisation
- CimCure B.V.
- Contact name
- Arjan Griffioen
Public contact point
- Organisation
- CimCure B.V.
- Contact name
- Diederik Engbersen
Locations
1 EU/EEA country · 4 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Ongoing, recruiting | 83 | 4 |
| Rest of world | — | 0 | — |
Investigational sites
Netherlands Cancer Institute
Medical Oncology, Plesmanlaan 121, 1066 CX, Amsterdam
Amsterdam UMC Stichting
Medical Oncology, De Boelelaan 1117, 1081 HV, Amsterdam
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Medical Oncology, Dr. Molewaterplein 40, 3015 GD, Rotterdam
Leids Universitair Medisch Centrum (LUMC)
Medical Oncology, Albinusdreef 2, 2333 ZA, Leiden
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 | 2026-04-14 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-11-10 | Netherlands | Acceptable 2026-01-27
|
2026-01-29 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2026-03-23 | Netherlands | Acceptable 2026-04-14
|
2026-04-14 |