Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ongoing, recruiting
Participants planned
540
Countries
1
Sites
6
Selected Advanced 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
- 24 Mar 2025 → ongoing
- Decision date (initial)
- 2025-03-08
- 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
Selected Advanced 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 · 6 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Ongoing, recruiting | 120 | 6 |
| Rest of world
United States, China, United Kingdom
|
— | 420 | — |
Investigational sites
Hospital Son Llatzer
Oncology, Carretera De Manacor Km 4, 07198, Palma
MD Anderson Cancer Center
Oncology, Calle De Arturo Soria Nº 270, 28033, Madrid
University Hospital Virgen Del Rocio S.L.
Oncology, Avenida De Manuel Siurot S/n, 41013, Sevilla
Hospital Hm Nou Delfos
START Barcelona- HM Nou Delfos, Avinguda De Vallcarca 151, 08023, Barcelona
Hospital Universitario Quironsalud Madrid
NEXT Madrid Phase I trials, Calle De Diego De Velazquez 1, 28223, Pozuelo De Alarcon
Hospital Universitario De Torrejon
Oncology, Calle De Mateo Inurria 1, 28850, Torrejon De Ardoz
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 | 2025-03-24 | 2025-03-25 |
Application history
4 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-11-22 | Spain | Acceptable with conditions 2025-03-08
|
2025-03-08 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-04-10 | Spain | Acceptable 2025-05-26
|
2025-05-26 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-12-18 | Spain | Acceptable 2026-03-23
|
2026-03-30 |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2026-04-01 | Spain | Acceptable 2026-05-18
|
2026-05-22 |