Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruiting
Participants planned
40
Countries
3
Sites
4
advanced/metastatic solid tumors
Key facts
- Sponsor
- SOTIO Biotech AG
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 22 Jul 2024 → ongoing
- Decision date (initial)
- 2024-04-17
- 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
advanced/metastatic solid tumors
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | SOC | 10029104 | Neoplasms benign malignant and unspecified (incl cysts and polyps) | 2 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
SOTIO Biotech AG
- Sponsor organisation
- SOTIO Biotech AG
- Address
- Lichtstrasse 35
- City
- Basel Town
- Postcode
- 4056
- Country
- Switzerland
Scientific contact point
- Organisation
- SOTIO Biotech AG
- Contact name
- Head of Communication Richard Kapsa
Public contact point
- Organisation
- SOTIO Biotech AG
- Contact name
- Head of Communication Richard Kapsa
Locations
3 EU/EEA countries · 4 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ongoing, recruiting | 12 | 2 |
| Czechia | Ongoing, recruiting | 12 | 1 |
| Spain | Ongoing, recruiting | 8 | 1 |
| Rest of world
United States
|
— | 8 | — |
Investigational sites
Institut Jules Bordet
Oncology, Mijlenmeersstraat 90, 1070, Anderlecht
Antwerp University Hospital
Oncology, Drie Eikenstraat 655, 2650, Edegem
Masarykuv Onkologicky Ustav
Oddělení klinické onkologie, Zluty Kopec 543/7, Stare Brno, Brno-Stred
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 |
|---|---|---|---|---|---|
| Belgium | 2024-07-25 | 2024-07-25 | |||
| Czechia | 2024-07-22 | 2024-07-22 | |||
| Spain | 2024-10-25 | 2024-10-25 |
Application history
8 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-12-07 | Belgium | Acceptable with conditions 2024-04-17
|
2024-04-17 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-06-28 | Belgium | Acceptable with conditions 2024-09-23
|
2024-09-25 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-11-04 | Belgium | Acceptable with conditions 2024-09-23
|
2024-11-04 |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-03-26 | Belgium | Acceptable with conditions 2024-09-23
|
2025-03-26 |
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-4 | 2026-03-10 | Belgium | Acceptable with conditions 2024-09-23
|
2026-03-10 |
| 6 | SUBSTANTIAL MODIFICATION | SM-2 | 2026-04-01 | Acceptable with conditions | 2026-04-16 | |
| 7 | SUBSTANTIAL MODIFICATION | SM-3 | 2026-04-01 | Acceptable with conditions | 2026-04-09 | |
| 8 | SUBSTANTIAL MODIFICATION | SM-4 | 2026-04-01 | Belgium | Acceptable with conditions | 2026-05-05 |