Overview
Sponsor-declared trial summary
Phase
Phase I and Phase II (Integrated) - Other
Status
Ongoing, recruiting
Participants planned
45
Countries
1
Sites
3
Advances solid tumors
Key facts
- Sponsor
- Pharma Mar S.A.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 23 Jun 2025 → ongoing
- Decision date (initial)
- 2025-04-14
- 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
Advances solid tumors
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Pharma Mar S.A.
- Sponsor organisation
- Pharma Mar S.A.
- Address
- Avenida De Los Reyes 1, Poligono Industrial La Mina Poligono Industrial La Mina
- City
- Colmenar Viejo
- Postcode
- 28770
- Country
- Spain
Scientific contact point
- Organisation
- Pharma Mar S.A.
- Contact name
- Clinical Development Oncology Unit
Public contact point
- Organisation
- Pharma Mar S.A.
- Contact name
- Clinical Development Oncology Unit
Locations
1 EU/EEA country · 3 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Ongoing, recruiting | 30 | 3 |
| Rest of world
United Kingdom
|
— | 15 | — |
Investigational sites
Hospital General Universitario Gregorio Maranon
Oncology, Calle Del Doctor Esquerdo 46, 28009, Madrid
Hospital San Pedro
Oncology, Calle Piqueras 98, 26006, Logrono
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 | 2025-06-23 | 2025-06-26 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-01-17 | Spain | Acceptable 2025-04-09
|
2025-04-14 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-09-30 | Spain | Acceptable | 2025-10-29 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-12-22 | Spain | Acceptable 2026-03-12
|
2026-03-17 |