Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruiting
Participants planned
23
Countries
1
Sites
1
Locally advanced rectal 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] - Neoplasms [C04], Diseases [C] - Digestive System Diseases [C06]
- Trial duration
- 12 Jan 2026 → ongoing
- Decision date (initial)
- 2024-03-18
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2023-507106-13-00
- ClinicalTrials.gov
- NCT06304597
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Locally advanced rectal cancer
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10038038 | Rectal cancer | 100000004864 |
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
- W.B. Nagengast
Public contact point
- Organisation
- Universitair Medisch Centrum Groningen
- Contact name
- W.B. Nagengast
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Ongoing, recruiting | 23 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Universitair Medisch Centrum Groningen
Gastroenterology and Hepatology, 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 | 2026-01-12 | 2026-01-12 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-11-21 | Netherlands | Acceptable 2024-03-18
|
2024-03-18 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-09-13 | Netherlands | Acceptable 2024-12-06
|
2024-12-06 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-09-04 | Netherlands | Acceptable 2025-12-01
|
2025-12-08 |