Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Authorised, recruitment pending
Participants planned
20
Countries
1
Sites
1
Rectal cancer with proficient mismatch repair (pMMR)
Key facts
- Sponsor
- Region Hovedstaden
- 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]
- Decision date (initial)
- 2026-02-23
- 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
Rectal cancer with proficient mismatch repair (pMMR)
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Region Hovedstaden
- Sponsor organisation
- Region Hovedstaden
- Address
- Bispebjerg Bakke 23
- City
- Copenhagen Nv
- Postcode
- 2400
- Country
- Denmark
Scientific contact point
- Organisation
- Region Hovedstaden
- Contact name
- Henry Smith
Public contact point
- Organisation
- Region Hovedstaden
- Contact name
- Henry Smith
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Denmark | Authorised, recruitment pending | 20 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Copenhagen University Hospital
Abdominalcenter K, Bispebjerg Bakke 23, 2400, Copenhagen Nv
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-12-08 | Denmark | Acceptable 2026-02-20
|
2026-02-23 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2026-05-28 | Denmark | Acceptable 2026-02-20
|
2026-05-28 |