Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Authorised, recruitment pending
Participants planned
97
Countries
4
Sites
9
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]
- Decision date (initial)
- 2026-05-22
- 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
Neoplasms
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Glaxosmithkline Research & Development Limited
- Sponsor organisation
- Glaxosmithkline Research & Development Limited
- Address
- 79 New Oxford Street
- City
- London
- Postcode
- WC1A 1DG
- 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
4 EU/EEA countries · 9 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Denmark | Authorised, recruitment pending | 7 | 1 |
| Finland | Authorised, recruitment pending | 7 | 1 |
| France | Not authorised | 14 | 2 |
| Spain | Authorised, recruitment pending | 24 | 5 |
| Rest of world
Japan, United States, United Kingdom, Canada
|
— | 45 | — |
Investigational sites
Rigshospitalet
Phase 1 Unit, Department of Oncology, Blegdamsvej 9, 2100, Copenhagen Oe
Institut Bergonie
Unité d'Essais Cliniques de Phase Précoce, 180 R De Saint Genes, 229 Cours De L Argonne, Bordeaux
Institut Gustave Roussy
Département Innovations Thérapeutiques et Essais Précoces (DITEP), 114 Rue Edouard Vaillant, 94800, Villejuif
Hospital Universitario Puerta De Hierro De Majadahonda
Oncología, Calle De Joaquin Rodrigo 2, 28222, Majadahonda
Clinica Universidad De Navarra
Oncología, Calle Marquesado De Santa Marta 1, 28027, Madrid
Hospital Universitario 12 De Octubre
Oncología, Avenida De Cordoba Sn, 28041, Madrid
Hospital Universitari Vall D Hebron
Oncología, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
Hospital Universitario Hm Sanchinarro
Oncología, Calle Ona 10, 28050, Madrid
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2026-03-13 | Finland | Acceptable 2026-05-21
|
2026-05-21 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2026-05-28 | Finland | Acceptable 2026-05-21
|
2026-05-28 |