Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ended
Participants planned
132
Countries
1
Sites
5
Solid Tumors
Key facts
- Sponsor
- Gilead Sciences Inc.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 2 Oct 2023 → 25 May 2026
- Decision date (initial)
- 2023-07-24
- 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
Solid Tumors
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Gilead Sciences Inc.
- Sponsor organisation
- Gilead Sciences Inc.
- Address
- 333 Lakeside Drive
- City
- Foster City
- Postcode
- 94404-1147
- Country
- United States
Scientific contact point
- Organisation
- Gilead Sciences Inc.
- Contact name
- EU Clinical Trial Support
Public contact point
- Organisation
- Gilead Sciences Inc.
- Contact name
- EU Clinical Trial Support
Locations
1 EU/EEA country · 5 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Ended | 41 | 5 |
| Rest of world
Taiwan, Korea, Republic of, Canada, United Kingdom, United States
|
— | 91 | — |
Investigational sites
Hospital Universitario Hm Sanchinarro
START Madrid - CIOCC, Calle Ona 10, 28050, Madrid
Hospital Universitari Vall D Hebron
Oncology, Passeig De La Vall D Hebron 119-129, 08035, Barcelona
University Clinic Of Navarra
Unidad Central de Ensayos Clinicos, Avenida De Pio XII 36, 31008, Pamplona
Hospital Universitario Fundacion Jimenez Diaz
Unidad Ensayos Fase I - Oncology, Avenida De Los Reyes Catolicos 2, 28040, Madrid
Hospital Quironsalud Barcelona
Unidad Ensayos Fase I - Oncology, Placa D'alfonso Comin 5-7, 08023, 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 | 2023-10-02 | 2026-05-25 | 2023-10-20 | 2025-11-03 |
Application history
9 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-04-28 | Spain | Acceptable 2023-07-14
|
2023-07-24 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2023-08-07 | Spain | Acceptable 2023-10-13
|
2023-10-13 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2023-12-22 | Spain | Acceptable 2024-03-11
|
2024-03-25 |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-10-15 | Spain | Acceptable 2024-11-29
|
2024-11-29 |
| 5 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-01-15 | Spain | Acceptable 2025-03-03
|
2025-03-05 |
| 6 | SUBSTANTIAL MODIFICATION | SM-5 | 2025-10-24 | Spain | Acceptable 2025-12-04
|
2025-12-10 |
| 7 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-12-17 | Spain | Acceptable 2025-12-04
|
2025-12-17 |
| 8 | SUBSTANTIAL MODIFICATION | SM-6 | 2026-01-09 | Spain | Acceptable 2026-02-16
|
2026-02-19 |
| 9 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2026-02-27 | Spain | Acceptable 2026-02-16
|
2026-02-27 |