Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Authorised, recruiting
Participants planned
178
Countries
1
Sites
3
Advanced 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
- 18 Dec 2025 → ongoing
- Decision date (initial)
- 2025-11-24
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Advanced solid tumors
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | PT | 10028997 | Neoplasm malignant | 100000004864 |
| 27.1 | PT | 10028980 | Neoplasm | 100000004864 |
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 CT Support
Public contact point
- Organisation
- Gilead Sciences Inc.
- Contact name
- EU CT Support
Locations
1 EU/EEA country · 3 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Authorised, recruiting | 35 | 3 |
| Rest of world
Canada, Korea, Republic of, United Kingdom, United States
|
— | 143 | — |
Investigational sites
Fundacio Hospital Universitari Vall D’Hebron Institut De Recerca
Oncology (VHIO), Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
Hospital Universitario Fundacion Jimenez Diaz
Start Madrid - FJD, Avenida De Los Reyes Catolicos 2, 28040, Madrid
Hospital Universitario Hm Sanchinarro
Start - Centro Integral Oncológico Clara Campal, Calle Ona 10, 28050, Madrid
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 | 2025-12-18 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-07-31 | Spain | Acceptable with conditions 2025-11-18
|
2025-11-24 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2026-01-22 | Spain | Acceptable with conditions | 2026-01-28 |