Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ongoing, recruiting
Participants planned
41
Countries
3
Sites
7
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
- 23 Aug 2023 → ongoing
- Decision date (initial)
- 2023-02-01
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2022-501508-82-00
- ClinicalTrials.gov
- NCT04617522
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 Trials Support
Public contact point
- Organisation
- Gilead Sciences Inc.
- Contact name
- EU Clinical Trials Support
Locations
3 EU/EEA countries · 7 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ongoing, recruiting | 30 | 3 |
| Italy | Authorised, recruitment pending | 10 | 2 |
| Spain | Authorised, recruiting | 1 | 2 |
| Rest of world | — | 0 | — |
Investigational sites
Institut De Cancerologie De L Ouest
Medical Oncology, 15 Rue Andre Boquel, 49100, Angers
Centre Leon Berard
Medical Oncology, 28 Rue Laennec, 69008, Lyon
Institut Bergonie
Medical Oncology, 229 Cours De L Argonne, 33000, Bordeaux
Istituto Europeo Di Oncologia S.r.l.
Divisione di Sviluppo di Nuovi Farmaci per Terapie Innovative, Via Giuseppe Ripamonti 435, 20141, Milan
IRCCS Istituto Nazionale Tumori Fondazione Pascale
Oncology, Via Mariano Semmola 52, 80131, Naples
Institut Catala D'oncologia
Oncology, Avinguda De La Gran Via De L'hospitalet 199-203, 08908, L'hospitalet De Llobregat
University Hospital Virgen Del Rocio S.L.
Oncology, Avenida De Manuel Siurot S/n, 41013, Sevilla
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 | 2023-08-23 | 2024-01-15 | |||
| Spain | 2026-01-29 |
Application history
10 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2022-10-21 | France | Acceptable 2023-01-27
|
2023-02-01 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2023-02-15 | France | Acceptable | 2023-03-17 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2023-08-09 | France | Acceptable | 2023-08-09 |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2024-06-18 | France | Acceptable | 2024-06-18 |
| 5 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-07-22 | France | Acceptable 2024-09-05
|
2024-09-05 |
| 6 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-02-18 | France | Acceptable 2025-03-26
|
2025-03-26 |
| 7 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-06-26 | France | Acceptable 2025-07-29
|
2025-07-29 |
| 8 | SUBSEQUENT ADDITION OF MSC | APP-8 | 2025-09-25 | Acceptable 2025-07-29
|
2025-12-18 | |
| 9 | SUBSEQUENT ADDITION OF MSC | APP-9 | 2025-11-19 | 2026-02-26 | ||
| 10 | SUBSTANTIAL MODIFICATION | SM-6 | 2026-03-17 | France | Acceptable 2026-05-11
|
2026-05-11 |