Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Authorised, recruiting
Participants planned
429
Countries
2
Sites
8
Head and Neck Squamous Cell Carcinoma, Non-Small-Cell Lung Cancer, Gastric and Esophagogastric Junction Adenocarcinoma, Microsatellite Stable Metastatic Colorectal Cancer
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
- 5 Oct 2023 → ongoing
- Decision date (initial)
- 2023-07-06
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2022-501684-40-00
- ClinicalTrials.gov
- NCT05007782
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Head and Neck Squamous Cell Carcinoma, Non-Small-Cell Lung Cancer, Gastric and Esophagogastric Junction Adenocarcinoma, Microsatellite Stable Metastatic Colorectal Cancer
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
2 EU/EEA countries · 8 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ended | 13 | 3 |
| Spain | Ongoing, recruiting | 80 | 5 |
| Rest of world
Canada, Australia, United States, Taiwan
|
— | 336 | — |
Investigational sites
UZ Leuven
Digestive Oncology, Herestraat 49, 3000, Leuven
Jessa Ziekenhuis
Respiratory Oncology, Stadsomvaart 11, 3500, Hasselt
Antwerp University Hospital
Digestive Oncology, Drie Eikenstraat 655, 2650, Edegem
Hospital Universitari Vall D Hebron
Medical Oncology, Edificio Materno-Infantil, Passeig De La Vall D'hebron 119-129, Barcelona
MD Anderson Cancer Center
Medical Oncology, Calle De Arturo Soria Nº 270, 28033, Madrid
Hospital Universitario 12 De Octubre
Medical Oncology, Bloque D, Avenida De Cordoba S/n, Madrid
Hospital Universitario Quironsalud Madrid
Medical Oncology, Calle De Diego De Velazquez 1, 28223, Pozuelo De Alarcon
Clinica Universidad De Navarra
Medical Oncology, Avenue Pio XII 36, 31008, Pamplona
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 | 2023-10-05 | 2023-11-06 |
Application history
10 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-03-31 | Spain | Acceptable 2023-07-04
|
2023-07-06 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2023-10-06 | Spain | Acceptable 2023-11-30
|
2023-11-30 |
| 3 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-02-28 | Spain | Acceptable 2024-04-29
|
2024-04-29 |
| 4 | SUBSTANTIAL MODIFICATION | SM-4 | 2024-05-31 | Spain | Acceptable 2024-07-11
|
2024-07-16 |
| 5 | SUBSTANTIAL MODIFICATION | SM-5 | 2024-09-26 | Spain | Acceptable 2024-11-11
|
2024-11-11 |
| 6 | SUBSTANTIAL MODIFICATION | SM-6 | 2024-11-25 | Spain | Acceptable 2025-01-23
|
2025-01-23 |
| 7 | SUBSTANTIAL MODIFICATION | SM-7 | 2025-02-28 | Spain | Acceptable 2025-03-29
|
2025-04-21 |
| 8 | SUBSTANTIAL MODIFICATION | SM-8 | 2025-08-08 | Spain | Acceptable 2025-09-02
|
2025-09-22 |
| 9 | SUBSTANTIAL MODIFICATION | SM-9 | 2025-10-28 | Spain | Acceptable 2025-12-01
|
2025-12-01 |
| 10 | SUBSTANTIAL MODIFICATION | SM-10 | 2026-01-12 | Spain | Acceptable 2026-04-06
|
2026-04-13 |