Overview
Sponsor-declared trial summary
Metastatic or locally advanced solid tumors for which no standard therapy exists or standard therapy has failed: tumors of lung, head and neck, colon, stomach, esophagus, breast, ovary and/or fallopian tube or primary peritoneal high-grade serous carcinoma
Key facts
- Sponsor
- VUAB Pharma a.s.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 7 Jun 2022 → ongoing
- Decision date (initial)
- 2024-09-09
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-511215-21-00
- EudraCT number
- 2020-005912-23
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Metastatic or locally advanced solid tumors for which no standard therapy exists or standard therapy has failed: tumors of lung, head and neck, colon, stomach, esophagus, breast, ovary and/or fallopian tube or primary peritoneal high-grade serous carcinoma
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
VUAB Pharma a.s.
- Sponsor organisation
- VUAB Pharma a.s.
- Address
- Vltavska 53
- City
- Roztoky
- Postcode
- 252 63
- Country
- Czechia
Scientific contact point
- Organisation
- VUAB Pharma a.s.
- Contact name
- Vladimír Kysilka
Public contact point
- Organisation
- VUAB Pharma a.s.
- Contact name
- Vladimír Kysilka
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Czechia | Ongoing, recruiting | 30 | 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 |
|---|---|---|---|---|---|
| Czechia | 2022-06-07 | 2022-06-07 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-08-07 | Czechia | Acceptable with conditions 2024-09-05
|
2024-09-09 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-02-11 | Czechia | Acceptable with conditions 2024-09-05
|
2025-02-11 |
| 3 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-08-05 | Czechia | Acceptable 2025-09-16
|
2025-10-01 |