Overview
Sponsor-declared trial summary
Selected tumor indications that are known to express FAP (Fibroblast activation protein) either on tumor stroma CAFs (Cancer-associated fibroblasts) (carcinomas) or on tumor cells (leiomyosarcomas and other sarcomas).
Key facts
- Sponsor
- Oncomatryx Biopharma S.L.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 20 Oct 2022 → ongoing
- Decision date (initial)
- 2024-07-01
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2024-514746-36-00
- EudraCT number
- 2021-002666-40
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Selected tumor indications that are known to express FAP (Fibroblast activation protein) either on tumor stroma CAFs (Cancer-associated fibroblasts) (carcinomas) or on tumor cells (leiomyosarcomas and other sarcomas).
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Oncomatryx Biopharma S.L.
- Sponsor organisation
- Oncomatryx Biopharma S.L.
- Address
- Parque Tecnologico De Bizkaia 801b 2p
- City
- Derio
- Postcode
- 48160
- Country
- Spain
Scientific contact point
- Organisation
- Oncomatryx Biopharma S.L.
- Contact name
- Chief Medical Officer
Public contact point
- Organisation
- Oncomatryx Biopharma S.L.
- Contact name
- Chief Medical Officer
Locations
1 EU/EEA country · 11 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Ongoing, recruiting | 113 | 11 |
| Rest of world
United States
|
— | 15 | — |
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 | 2022-10-20 | 2022-10-20 |
Application history
4 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-06-19 | Spain | Acceptable 2024-07-01
|
2024-07-01 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-09-30 | Spain | Acceptable 2024-11-28
|
2024-12-04 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-07-09 | Spain | Acceptable 2025-09-03
|
2025-09-05 |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2026-01-13 | Spain | Acceptable 2026-03-31
|
2026-04-22 |