Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ongoing, recruiting
Participants planned
540
Countries
1
Sites
7
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 · 7 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Ongoing, recruiting | 120 | 7 |
| Rest of world
United States, China, United Kingdom
|
— | 420 | — |
Investigational sites
Hospital Son Llatzer
Oncology, Carretera De Manacor Km 4, 07198, Palma
Hospital Hm Nou Delfos
START Barcelona- HM Nou Delfos, Avinguda De Vallcarca 151, 08023, Barcelona
Hospital Universitario De Torrejon
Oncology, Calle De Mateo Inurria 1, 28850, Torrejon De Ardoz
Hospital Universitario Quironsalud Madrid
NEXT Madrid Phase I trials, Calle De Diego De Velazquez 1, 28223, Pozuelo De Alarcon
University Hospital Virgen Del Rocio S.L.
Oncology, Avenida De Manuel Siurot S/n, 41013, Sevilla
MD Anderson Cancer Center
Oncology, Calle De Arturo Soria Nº 270, 28033, Madrid
Hospital De La Santa Creu I Sant Pau
Oncology, Carrer De San Quinti 89, 08041, Barcelona
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
5 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 |
| 5 | SUBSTANTIAL MODIFICATION | SM-4 | 2026-05-26 | Spain | Acceptable | 2026-06-11 |