Overview
Sponsor-declared trial summary
Phase
Phase I and Phase II (Integrated) - First administration to humans
Status
Not authorised
Participants planned
18
Countries
1
Sites
3
Patients with HER2Positive Advanced Breast Cancer
Key facts
- Sponsor
- Fundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I Sunyer
- Participant type
- Patients
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04], Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01], Phenomena and Processes [G] - Immune system processes [G12], Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutics [E02], Diseases [C] - Female Urogenital Diseases and Pregnancy Complications [C13]
- Decision date (initial)
- 2025-10-15
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Patients with HER2Positive Advanced Breast Cancer
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | LLT | 10072737 | Advanced breast cancer | 10029104 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Fundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I Sunyer
- Sponsor organisation
- Fundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I Sunyer
- Address
- Calle Rosellon 149-153
- City
- Barcelona
- Postcode
- 08036
- Country
- Spain
Scientific contact point
- Organisation
- Fundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I Sunyer
- Contact name
- Laura Angelats
Public contact point
- Organisation
- Fundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I Sunyer
- Contact name
- Laura Angelats
Locations
1 EU/EEA country · 3 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Not authorised | 18 | 3 |
| Rest of world | — | 0 | — |
Investigational sites
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-06-10 | Spain | Not acceptable 2025-10-14
|
2025-10-15 |