Overview
Sponsor-declared trial summary
Phase
Phase I and Phase II (Integrated) - First administration to humans
Status
Ended
Participants planned
150
Countries
2
Sites
7
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
- 4 Sep 2017 → 22 Aug 2025
- Decision date (initial)
- 2024-05-02
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2024-511916-25-00
- EudraCT number
- 2017-001118-27
- ClinicalTrials.gov
- NCT05076396
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
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
2 EU/EEA countries · 7 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ended | 25 | 1 |
| Spain | Ended | 90 | 6 |
| Rest of world
United States
|
— | 35 | — |
Investigational sites
Hospital Universitario 12 De Octubre
Oncology, Bloque D, Avenida De Cordoba Sn, Madrid
Clinica Universidad De Navarra
Oncology, Calle Marquesado De Santa Marta 1, 28027, Madrid
Hospital General Universitario Gregorio Maranon
Medical Oncology, Calle Del Doctor Esquerdo 46, 28009, Madrid
Hospital Universitario Fundacion Jimenez Diaz
START Madrid-FJD, Avenida De Los Reyes Catolicos 2, 28040, Madrid
Hospital Universitario Hm Sanchinarro
START Madrid-HM CIOCC, Calle Ona 10, 28050, Madrid
Vall D'hebron Institut De Recerca
Medical Oncology, Passeig De La Vall D'hebron 119-129, 08035, 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 |
|---|---|---|---|---|---|
| France | 2018-02-22 | 2018-02-22 | |||
| Spain | 2017-09-04 | 2025-08-21 | 2017-09-06 | 2025-01-29 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-03-19 | Spain | Acceptable 2024-04-26
|
2024-04-26 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-11-15 | Spain | Acceptable 2025-01-03
|
2025-01-14 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-02-19 | Spain | Acceptable | 2025-02-24 |