Overview
Sponsor-declared trial summary
Phase
Phase I and Phase II (Integrated) - First administration to humans
Status
Ongoing, recruiting
Participants planned
110
Countries
3
Sites
14
Advance 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
- 28 Feb 2023 → ongoing
- Decision date (initial)
- 2023-12-05
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2023-508644-22-00
- EudraCT number
- 2022-002031-65
- ClinicalTrials.gov
- NCT05841563
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Advance Solid Tumors
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | LLT | 10007050 | Cancer | 10029104 |
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
- Chelo Tudela
Public contact point
- Organisation
- Pharma Mar S.A.
- Contact name
- Chelo Tudela
Locations
3 EU/EEA countries · 14 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ongoing, recruiting | 35 | 3 |
| France | Ongoing, recruiting | 15 | 3 |
| Spain | Ongoing, recruiting | 35 | 8 |
| Rest of world
United States
|
— | 25 | — |
Investigational sites
Grand Hopital De Charleroi
Medical Oncology, Rue Du Campus Des Viviers 1, 6060, Charleroi
Universitair Ziekenhuis Antwerpen
Medical Oncology, Drie Eikenstraat 655, 2650, Edegem
Institut Jules Bordet
Clinical Trial Conduct Unit, Mijlenmeersstraat 90, 1070, Anderlecht
Assistance Publique Hopitaux De Paris
Oncology, 27 Rue Du Faubourg Saint Jacques, 75014, Paris
Centre Hospitalier Regional De Marseille
Oncology, 265 Chemin Des Bourrely, 13015, Marseille
Institut Paoli Calmettes
Oncology, 232 Boulevard De Sainte Marguerite, Bp 156, Marseille
Hospital Universitari Vall D Hebron
Oncology, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
Hospital Universitario Y Politecnico La Fe
Oncology, Avenida De Fernando Abril Martorell 106, 46026, Valencia
Hospital San Pedro
Oncology, Calle Piqueras 98, 26006, Logrono
Hospital Universitario 12 De Octubre
Oncology, Avenida De Cordoba Sn, 28041, Madrid
NEXT Oncology Barcelona - Hospital Quiron Salud Barcelona
Oncology, Plaza Alfonso Comín 5-7, 08023, Barcelona
Hospital Universitario Ramon Y Cajal
Oncology, Carretera Del Colmenar Viejo Km 9 100, Por El Pardo, Madrid
Hospital Universitario Hm Sanchinarro
Oncology, Calle Ona 10, 28050, Madrid
Hospital Universitario Quironsalud Madrid
Oncology, Calle De Diego De Velazquez 1, 28223, Pozuelo De Alarcon
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 |
|---|---|---|---|---|---|
| Belgium | 2023-06-14 | 2023-07-20 | |||
| France | 2025-12-22 | 2026-04-13 | |||
| Spain | 2023-02-28 | 2023-03-24 |
Application history
14 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-10-23 | Spain | Acceptable 2023-11-14
|
2023-11-14 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-02-20 | Spain | Acceptable 2024-04-22
|
2024-04-22 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-06-26 | Spain | Acceptable 2024-08-05
|
2024-08-07 |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-10-11 | Spain | Acceptable | 2024-10-28 |
| 5 | SUBSEQUENT ADDITION OF MSC | APP-5 | 2024-10-25 | Acceptable 2024-08-05
|
2025-01-15 | |
| 6 | SUBSTANTIAL MODIFICATION | SM-4 | 2024-11-21 | Acceptable | 2024-12-18 | |
| 7 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-02-14 | Spain | Acceptable | 2025-02-14 |
| 8 | SUBSTANTIAL MODIFICATION | SM-6 | 2025-04-14 | Spain | Acceptable 2025-05-29
|
2025-05-29 |
| 9 | SUBSTANTIAL MODIFICATION | SM-7 | 2025-07-10 | Spain | Acceptable 2025-08-19
|
2025-08-22 |
| 10 | SUBSTANTIAL MODIFICATION | SM-8 | 2025-09-24 | Acceptable | 2025-10-21 | |
| 11 | SUBSTANTIAL MODIFICATION | SM-9 | 2025-09-24 | Acceptable | 2025-10-24 | |
| 12 | SUBSTANTIAL MODIFICATION | SM-10 | 2025-09-30 | Spain | Acceptable | 2025-10-27 |
| 13 | SUBSTANTIAL MODIFICATION | SM-11 | 2026-01-22 | Spain | Acceptable 2026-05-04
|
2026-05-05 |
| 14 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2026-05-22 | Spain | Acceptable 2026-05-04
|
2026-05-22 |