Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ended
Participants planned
20
Countries
1
Sites
1
advanced pancreatic cancer
Key facts
- Sponsor
- Region Hovedstaden
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 3 May 2023 → 16 Mar 2026
- Decision date (initial)
- 2024-09-13
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2024-515966-14-00
- EudraCT number
- 2022-002734-13
- ClinicalTrials.gov
- NCT05721846
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
advanced pancreatic cancer
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 27.0 | LLT | 10033605 | Pancreatic cancer metastatic | 10029104 |
| 21.0 | LLT | 10033607 | Pancreatic cancer recurrent | 10029104 |
| 21.0 | LLT | 10033606 | Pancreatic cancer non-resectable | 10029104 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Region Hovedstaden
- Sponsor organisation
- Region Hovedstaden
- Address
- Borgmester Ib Juuls Vej 1
- City
- Herlev
- Postcode
- 2730
- Country
- Denmark
Scientific contact point
- Organisation
- Region Hovedstaden
- Contact name
- Sponsor Investigator Inna Chen
Public contact point
- Organisation
- Region Hovedstaden
- Contact name
- Sponsor Investigator Inna Chen
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Denmark | Ended | 20 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
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 |
|---|---|---|---|---|---|
| Denmark | 2023-05-03 | 2026-03-16 | 2023-05-16 | 2025-03-27 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-09-03 | Denmark | Acceptable 2024-09-13
|
2024-09-13 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-10-21 | Denmark | Acceptable 2025-11-26
|
2025-11-26 |