Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruiting
Participants planned
140
Countries
1
Sites
1
Patients with breast cancer, gastroesophageal adenocarcinomas or cancers with alterations in the ERBBR2 gene
Key facts
- Sponsor
- Rigshospitalet
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 22 Sep 2025 → ongoing
- Decision date (initial)
- 2024-11-05
- 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
Patients with breast cancer, gastroesophageal adenocarcinomas or cancers with alterations in the ERBBR2 gene
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10001150 | Adenocarcinoma gastric | 100000004864 |
| 23.0 | PT | 10075638 | HER2 protein overexpression | 100000004850 |
| 20.0 | PT | 10006187 | Breast cancer | 100000004864 |
| 21.1 | LLT | 10066354 | Adenocarcinoma of the gastroesophageal junction | 10029104 |
| 23.0 | PT | 10075653 | HER2 gene amplification | 100000004850 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Rigshospitalet
- Sponsor organisation
- Rigshospitalet
- Address
- Blegdamsvej 9
- City
- Copenhagen Oe
- Postcode
- 2100
- Country
- Denmark
Scientific contact point
- Organisation
- Rigshospitalet
- Contact name
- Andreas Kjær
Public contact point
- Organisation
- Rigshospitalet
- Contact name
- Malene Martini Clausen
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Denmark | Ongoing, recruiting | 140 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Rigshospitalet
Department of Clinical Physiology and Nuclear Medicine, Blegdamsvej 9, 2100, Copenhagen Oe
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 | 2025-09-22 | 2025-09-22 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-08-06 | Denmark | Acceptable 2024-11-04
|
2024-11-05 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-04-23 | Denmark | Acceptable 2025-06-03
|
2025-06-04 |