Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruiting
Participants planned
15
Countries
1
Sites
3
Esophageal cancer
Key facts
- Sponsor
- Universitair Medisch Centrum Groningen
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Digestive System Diseases [C06], Diseases [C] - Neoplasms [C04]
- Trial duration
- 1 May 2026 → ongoing
- Decision date (initial)
- 2025-06-13
- 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
Esophageal cancer
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Universitair Medisch Centrum Groningen
- Sponsor organisation
- Universitair Medisch Centrum Groningen
- Address
- Hanzeplein 1
- City
- Groningen
- Postcode
- 9713 GZ
- Country
- Netherlands
Scientific contact point
- Organisation
- Universitair Medisch Centrum Groningen
- Contact name
- Wouter Nagengast
Public contact point
- Organisation
- Universitair Medisch Centrum Groningen
- Contact name
- Wouter Nagengast
Locations
1 EU/EEA country · 3 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Ongoing, recruiting | 15 | 3 |
| Rest of world | — | 0 | — |
Investigational sites
Stichting Martini Ziekenhuis
Maag-, darm-, leverziekten, Van Swietenplein 1, 9728 NT, Groningen
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Department Otorhinolaryngology, Head and Neck Surgery, Dr. Molewaterplein 40, 3015 GD, Rotterdam
Universitair Medisch Centrum Groningen
Maag-, darm-, leverziekten, Hanzeplein 1, 9713 GZ, Groningen
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 | 2026-05-01 | 2026-05-01 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-03-05 | Netherlands | Acceptable with conditions 2025-06-13
|
2025-06-13 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-08-11 | Netherlands | Acceptable with conditions 2025-06-13
|
2025-08-11 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2026-02-09 | Netherlands | Acceptable 2026-02-26
|
2026-02-26 |