Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ongoing, recruiting
Participants planned
63
Countries
1
Sites
6
Advanced/Metastatic Pancreatic Adenocarcinoma
Key facts
- Sponsor
- Oncomatryx Biopharma S.A.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 28 Oct 2025 → ongoing
- Decision date (initial)
- 2025-09-01
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Advanced/Metastatic Pancreatic Adenocarcinoma
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Oncomatryx Biopharma S.A.
- Sponsor organisation
- Oncomatryx Biopharma S.A.
- Address
- Parque Tecnologico De Bizkaia 801b 2p
- City
- Derio
- Postcode
- 48160
- Country
- Spain
Scientific contact point
- Organisation
- Oncomatryx Biopharma S.L.
- Contact name
- Ignacio Garcia-Ribas
Public contact point
- Organisation
- Oncomatryx Biopharma S.L.
- Contact name
- Ignacio Garcia-Ribas
Locations
1 EU/EEA country · 6 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Ongoing, recruiting | 54 | 6 |
| Rest of world
United States
|
— | 9 | — |
Investigational sites
Hospital Universitario Donostia
Oncology, Pasealeku Doct. Begiristain 109, 20014, Donostia
Complexo Hospitalario Universitario De Santiago
Oncology, Calle Choupana Da S/n, 15706, Santiago De Compostela
Hospital Universitari Vall D Hebron
Oncology, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
Hospital Universitario 12 De Octubre
Oncology, Avenida De Cordoba Sn, 28041, Madrid
Clinica Universidad De Navarra
Oncology, Pio XII Etorbidea 36, 31008, Pamplona
Institut Catala D'oncologia
Oncology, Avinguda De La Gran Via De L'hospitalet 199-203, 08908, L'hospitalet De Llobregat
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 | 2025-10-28 | 2025-10-28 |
Application history
4 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-06-12 | Spain | Acceptable 2025-08-20
|
2025-09-01 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-10-01 | Spain | Acceptable | 2025-10-24 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2026-01-28 | Spain | Acceptable | 2026-01-28 |
| 4 | SUBSTANTIAL MODIFICATION | SM-2 | 2026-02-02 | Spain | Acceptable | 2026-02-11 |