Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ongoing, recruiting
Participants planned
536
Countries
3
Sites
17
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
- 17 Sep 2025 → ongoing
- Decision date (initial)
- 2025-08-12
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-513663-10-01
- ClinicalTrials.gov
- NCT06551142
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
3 EU/EEA countries · 17 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ongoing, recruiting | 60 | 3 |
| Italy | Ongoing, recruiting | 40 | 5 |
| Spain | Ongoing, recruiting | 60 | 9 |
| Rest of world
Canada, Korea, Republic of, United Kingdom, Taiwan, Japan, Panama, Hong Kong, Israel, United States, Argentina
|
— | 376 | — |
Investigational sites
Institut Bergonie
Departement d'Oncologie Medicale, 180 R De Saint Genes, 229 Cours De L Argonne, Bordeaux
Centre Leon Berard
Departement de Cancerologie Medicale, 28 Rue Laennec, 69008, Lyon
Institut Gustave Roussy
Departement Innovations Therapeutiques et Groupe Oncologie Genito-Urinaire, 114 Rue Edouard Vaillant, 94800, Villejuif
Centro Ricerche Cliniche Di Verona S.r.l.
Centro Ricerche Cliniche di Verona, Piazzale Ludovico Antonio Scuro 10, 37134, Verona
IRCCS Istituto Nazionale Tumori Fondazione Pascale
S.C. Sperimentazioni Cliniche, Via Mariano Semmola 52, 80131, Naples
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Unità Operativa di Fase 1, Largo Francesco Vito 1, 00168, Rome
Humanitas Mirasole S.p.A.
Phase I Clinical Trial Unit, Via Alessandro Manzoni 56, 20089, Rozzano
Istituto Europeo Di Oncologia S.r.l.
Divisione Sviluppo di Nuovi Farmaci per Terapie Innovative, Via Giuseppe Ripamonti 435, 20141, Milan
Hospital Universitari Vall D Hebron
Oncología Médica, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
Hospital Clinic De Barcelona
Oncología, Unidad de Ensayos Clínicos de Fase Temprana, Calle Villarroel 170, 08036, Barcelona
Hospital Universitario Y Politecnico La Fe
Oncología Médica, Avenida Fernando Abril Martorell 106, 46026, Valencia
Hospital Universitario Virgen De La Victoria
Oncología, IBIMA Unidad de Fase 1, Calle Del Arroyo Teatinos S/N, 29010, Malaga
Hospital Universitario 12 De Octubre
Oncología Médica, Avenida De Cordoba Sn, 28041, Madrid
Hospital Universitario De Badajoz
Oncología Médica, Avenida Elvas S/n, 06006, Badajoz
Hospital Universitario Fundacion Jimenez Diaz
Oncología, Unidad de Fase 1, Avenida De Los Reyes Catolicos 2, 28040, Madrid
Hospital Clinico Universitario Lozano Blesa
Oncología Médica, Avenida De San Juan Bosco 15, 50009, Zaragoza
Hospital Universitario Ramon Y Cajal
Oncología Médica, Carretera Del Colmenar Viejo Km 9 100, Por El Pardo, 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 |
|---|---|---|---|---|---|
| France | 2025-09-17 | 2025-09-17 | |||
| Italy | 2025-12-10 | 2025-12-10 | |||
| Spain | 2025-09-23 | 2025-09-23 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-04-14 | Italy | Acceptable 2025-08-11
|
2025-08-11 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-10-14 | Italy | Acceptable 2025-08-11
|
2025-10-14 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-10-31 | Italy | Acceptable 2026-02-18
|
2026-02-19 |