Overview
Sponsor-declared trial summary
Phase
Phase I and Phase II (Integrated) - First administration to humans
Status
Authorised, recruitment pending
Participants planned
82
Countries
1
Sites
1
TRIPLE NEGATIVE BREAST CANCER
Key facts
- Sponsor
- Celica d.o.o.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Decision date (initial)
- 2026-03-31
- 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
TRIPLE NEGATIVE BREAST CANCER
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10075566 | Triple negative breast cancer | 100000004864 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Celica d.o.o.
2
Total trials
Academic / Non-commercial
- Sponsor organisation
- Celica d.o.o.
- Address
- Tehnoloski Park 24
- City
- Ljubljana
- Postcode
- 1000
- Country
- Slovenia
Scientific contact point
- Organisation
- Celica d.o.o.
- Contact name
- Clinical trial Information desk
Public contact point
- Organisation
- Celica d.o.o.
- Contact name
- Clinical trial Information desk
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Slovenia | Authorised, recruitment pending | 82 | 1 |
| 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 | 2025-12-25 | Slovenia | Acceptable with conditions 2026-02-24
|
2026-03-31 |