Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruiting
Participants planned
15
Countries
1
Sites
2
Locally advanced, recurrent, or metastatic breast, gastric, endometrial, and selected other solid tumors with positive expression for HER-2 (3+)
Key facts
- Sponsor
- Vall D Hebron Institute Of Oncology
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 17 Apr 2026 → ongoing
- Decision date (initial)
- 2025-12-17
- 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
Locally advanced, recurrent, or metastatic breast, gastric, endometrial, and selected other solid tumors with positive expression for HER-2 (3+)
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 27.0 | PT | 10063916 | Metastatic gastric cancer | 100000004864 |
| 27.0 | LLT | 10027475 | Metastatic breast cancer | 10029104 |
| 27.0 | PT | 10014734 | Endometrial cancer metastatic | 100000004864 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Vall D Hebron Institute Of Oncology
- Sponsor organisation
- Vall D Hebron Institute Of Oncology
- Address
- Calle Natzaret 115
- City
- Barcelona
- Postcode
- 08035
- Country
- Spain
Scientific contact point
- Organisation
- Vall D Hebron Institute Of Oncology
- Contact name
- Group Leader, VHIO
Public contact point
- Organisation
- Vall D Hebron Institute Of Oncology
- Contact name
- Group Leader, VHIO
Locations
1 EU/EEA country · 2 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Ongoing, recruiting | 15 | 2 |
| 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 |
|---|---|---|---|---|---|
| Spain | 2026-04-17 | 2026-04-29 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-10-13 | Spain | Acceptable 2025-12-17
|
2025-12-17 |