Overview
Sponsor-declared trial summary
Phase
Phase I and Phase II (Integrated) - First administration to humans
Status
Ongoing, recruiting
Participants planned
145
Countries
1
Sites
3
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
- 1 Dec 2022 → ongoing
- Decision date (initial)
- 2024-04-30
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2024-513056-15-00
- EudraCT number
- 2022-002032-31
- ClinicalTrials.gov
- NCT05835609
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
1 EU/EEA country · 3 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Ongoing, recruiting | 145 | 3 |
| Rest of world | — | 0 | — |
Investigational sites
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 | 2022-12-01 | 2022-12-23 |
Application history
5 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-04-26 | Spain | Acceptable 2024-04-30
|
2024-04-30 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-11-15 | Spain | Acceptable 2025-01-27
|
2025-02-05 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-03-24 | Spain | Acceptable 2025-05-07
|
2025-05-07 |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-07-21 | Spain | Acceptable | 2025-07-24 |
| 5 | SUBSTANTIAL MODIFICATION | SM-5 | 2025-12-22 | Spain | Acceptable 2026-03-28
|
2026-04-06 |