Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruiting
Participants planned
20
Countries
1
Sites
4
advanced or metastasic triple-negative 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, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 5 May 2025 → ongoing
- Decision date (initial)
- 2024-06-20
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-511915-21-01
- ClinicalTrials.gov
- NCT05451784
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
advanced or metastasic triple-negative breast cancer
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 23.0 | LLT | 10084066 | Triple negative breast cancer metastatic | 10029104 |
| 20.0 | PT | 10075566 | Triple negative breast cancer | 100000004864 |
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
- Aleix Prat
Public contact point
- Organisation
- Fundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I Sunyer
- Contact name
- Aleix Prat
Locations
1 EU/EEA country · 4 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Ongoing, recruiting | 20 | 4 |
| Rest of world | — | 0 | — |
Investigational sites
Hospital Universitario 12 De Octubre
Oncology, Bloque D, Avenida De Cordoba Sn, Madrid
Hospital Clinic De Barcelona
Oncology, Calle Villarroel 170, 08036, Barcelona
Hospital Universitari Vall D Hebron
Oncology, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
Clinica Universidad De Navarra
Oncology, Avenue Pio XII 36, 31008, Pamplona
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 | 2024-06-20 | 2024-06-20 |
Oversight and notifications
Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77
Temporary halts 1 · Art. 38 CTR
Temporary halt TH-73728
- Halt date
- 2025-02-24
- Member states concerned
- Spain
- Publication date
- 2025-03-07
- Reason
- Sponsor decision, Study management related
- Explanation
- Due to administrative and financial reasons we are forced to put on hold the recruitment of the trial, expecting the reinitiation as we finish some administrative documents that will allow the allocation of a grant received for this trial. Furthermore, we can focus on analyzing the safety of the treatment (as planned by protocol) of the first 10/20 patients included in the trial.
- Follow-up measures
- We keep monitoring the patients included. We keep the Tumor assessments and we are performing a planned interim analysis while the pause of the recruitment is happening.
- Benefit-risk balance changed
- No
- Treatment stopped
- No
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-06-13 | Spain | Acceptable 2024-06-20
|
2024-06-20 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-07-29 | Spain | Acceptable 2025-10-13
|
2025-10-20 |