Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruitment ended
Participants planned
158
Countries
2
Sites
4
Neoplasms
Key facts
- Sponsor
- Glaxosmithkline Research & Development Limited
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 24 May 2023 → ongoing
- Decision date (initial)
- 2024-06-04
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2023-509414-11-00
- EudraCT number
- 2021-004968-95
- ClinicalTrials.gov
- NCT05277051
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Neoplasms
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.0 | LLT | 10049280 | Solid tumour | 10029104 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Glaxosmithkline Research & Development Limited
- Sponsor organisation
- Glaxosmithkline Research & Development Limited
- Address
- G S K House, 980 Great West Road 980 Great West Road
- City
- Brentford
- Postcode
- TW8 9GS
- Country
- United Kingdom
Scientific contact point
- Organisation
- Glaxosmithkline Research & Development Limited
- Contact name
- EU GSK Clinical Trials Call Center
Public contact point
- Organisation
- Glaxosmithkline Research & Development Limited
- Contact name
- EU GSK Clinical Trials Call Center
Locations
2 EU/EEA countries · 4 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ended | 12 | 2 |
| Spain | Ongoing, recruitment ended | 20 | 2 |
| Rest of world
Australia, United States, Japan, China, Canada
|
— | 126 | — |
Investigational sites
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 | 2023-05-24 | 2025-07-07 | 2023-05-24 | 2024-06-27 | |
| Spain | 2023-05-24 | 2023-05-30 | 2025-04-02 |
Application history
7 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-03-26 | Spain | Acceptable 2024-05-14
|
2024-05-14 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-07-10 | Spain | Acceptable | 2024-07-22 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-10-31 | Spain | Acceptable with conditions 2025-02-03
|
2025-02-03 |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-03-20 | Spain | Acceptable with conditions | 2025-03-31 |
| 5 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-07-03 | Spain | Acceptable 2025-08-18
|
2025-08-20 |
| 6 | SUBSTANTIAL MODIFICATION | SM-5 | 2025-11-20 | Spain | Acceptable 2026-01-19
|
2026-01-21 |
| 7 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2026-02-20 | Spain | Acceptable 2026-01-19
|
2026-02-20 |