Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruiting
Participants planned
57
Countries
1
Sites
1
Solid tumor
Key facts
- Sponsor
- Leukos Biotech S.L.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 7 Aug 2024 → ongoing
- Decision date (initial)
- 2024-06-11
- 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
Solid tumor
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | HLGT | 10025323 | Lymphomas NEC | 10029104 |
| 21.1 | LLT | 10065147 | Malignant solid tumor | 10029104 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Leukos Biotech S.L.
- Sponsor organisation
- Leukos Biotech S.L.
- Address
- Calle Muntaner 383
- City
- Barcelona
- Postcode
- 08021
- Country
- Spain
Scientific contact point
- Organisation
- Leukos Biotech S.L.
- Contact name
- Ruth Muñoz Risueño
Public contact point
- Organisation
- Leukos Biotech S.L.
- Contact name
- Luís Ruiz-Avila
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Ongoing, recruiting | 57 | 1 |
| 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 | 2024-08-07 | 2024-08-14 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-03-05 | Spain | Acceptable 2024-06-05
|
2024-06-11 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-01-31 | Spain | Acceptable 2025-04-10
|
2025-04-10 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-10-03 | Spain | Acceptable 2026-01-26
|
2026-02-02 |