Clinical trial • Phase I • Oncology
GSK5764227 for Advanced solid tumours
Phase I trial of GSK5764227 for Advanced solid tumours. 376 participants.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Advanced solid tumours
- Trial Stage
- Phase I
Key dates
- Initial CTIS Submission Date
- 14-04-2025
- First CTIS Authorization Date
- 11-08-2025
Trial design
Phase I trial across 17 sites in Italy, Spain, France.
- Single Multiple Or Escalation Dose Combined
- Yes
- Target Sample Size
- 376
Eligibility
Recruits 376 No vulnerable population selected (isVulnerablePopulationSelected=false).
- Vulnerable Population
- No vulnerable population selected (isVulnerablePopulationSelected=false)
Recruitment
- Planned Sample Size
- 376
- Recruitment Window Months
- 21
- Consent Approach
- Not specified in CTIS; CTIS indicates adult participants only (isVulnerablePopulationSelected=false). No details on assent, consent documents or languages provided in the available record.
Geography
- Total Number Of Sites
- 17
- Total Number Of Participants
- 160
Italy
- Earliest CTIS Part Ii Submission Date
- 23-07-2025
- Latest Decision Or Authorization Date
- 19-02-2026
- Processing Time Days
- 211
- Number Of Sites
- 5
- Number Of Participants
- 40
Sites
- Site Name
- Humanitas Mirasole S.p.A.
- Department Name
- Phase I Clinical Trial Unit
- Principal Investigator Name
- Matteo Simonelli
- Principal Investigator Email
- matteo.simonelli@cancercenter.humanitas.it
- Contact Person Name
- Matteo Simonelli
- Contact Person Email
- matteo.simonelli@cancercenter.humanitas.it
- Site Name
- Istituto Europeo Di Oncologia S.r.l.
- Department Name
- Divisione Sviluppo di Nuovi Farmaci per Terapie Innovative
- Principal Investigator Name
- Giuseppe Curigliano
- Principal Investigator Email
- giuseppe.curigliano@ieo.it
- Contact Person Name
- Giuseppe Curigliano
- Contact Person Email
- giuseppe.curigliano@ieo.it
- Site Name
- Centro Ricerche Cliniche Di Verona S.r.l.
- Department Name
- Centro Ricerche Cliniche di Verona
- Principal Investigator Name
- Andrea Zivi
- Principal Investigator Email
- andrea.zivi@aovr.veneto.it
- Contact Person Name
- Andrea Zivi
- Contact Person Email
- andrea.zivi@aovr.veneto.it
- Site Name
- IRCCS Istituto Nazionale Tumori Fondazione Pascale
- Department Name
- S.C. Sperimentazioni Cliniche
- Principal Investigator Name
- Adriano Gravina
- Principal Investigator Email
- a.gravina@istitutotumori.na.it
- Contact Person Name
- Adriano Gravina
- Contact Person Email
- a.gravina@istitutotumori.na.it
- Site Name
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Department Name
- Unità Operativa di Fase 1
- Principal Investigator Name
- Gennaro Daniele
- Principal Investigator Email
- gennaro.daniele@policlinogemelli.it
- Contact Person Name
- Gennaro Daniele
- Contact Person Email
- gennaro.daniele@policlinogemelli.it
Spain
- Earliest CTIS Part Ii Submission Date
- 18-07-2025
- Latest Decision Or Authorization Date
- 26-02-2026
- Processing Time Days
- 223
- Number Of Sites
- 9
- Number Of Participants
- 60
Sites
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- Oncología Médica
- Principal Investigator Name
- Enriqueta Felip Font
- Principal Investigator Email
- enriqueta.felip@vallhebron.cat
- Contact Person Name
- Enriqueta Felip Font
- Contact Person Email
- enriqueta.felip@vallhebron.cat
- Site Name
- Hospital Universitario Y Politecnico La Fe
- Department Name
- Oncología Médica
- Principal Investigator Name
- Oscar Juan Vidal
- Principal Investigator Email
- juan_osc@gva.es
- Contact Person Name
- Oscar Juan Vidal
- Contact Person Email
- juan_osc@gva.es
- Site Name
- Hospital Clinic De Barcelona
- Department Name
- Oncología, Unidad de Ensayos Clínicos de Fase Temprana
- Principal Investigator Name
- Iván Victoria Ruiz
- Principal Investigator Email
- ivictori@recerca.clinic.cat
- Contact Person Name
- Iván Victoria Ruiz
- Contact Person Email
- ivictori@recerca.clinic.cat
- Site Name
- Hospital Universitario Fundacion Jimenez Diaz
- Department Name
- Oncología, Unidad de Fase 1
- Principal Investigator Name
- Victor Moreno García
- Principal Investigator Email
- victor.moreno@startmadrid.com
- Contact Person Name
- Victor Moreno García
- Contact Person Email
- victor.moreno@startmadrid.com
- Site Name
- Hospital Universitario Virgen De La Victoria
- Department Name
- Oncología, IBIMA Unidad de Fase 1
- Principal Investigator Name
- Javier García Corbacho
- Principal Investigator Email
- fasestempranas@ibima.eu
- Contact Person Name
- Javier García Corbacho
- Contact Person Email
- fasestempranas@ibima.eu
- Site Name
- Hospital Universitario Ramon Y Cajal
- Department Name
- Oncología Médica
- Principal Investigator Name
- María Eugenia Olmedo García
- Principal Investigator Email
- mariaeugenia.olmedo@salud.madrid.org
- Contact Person Name
- María Eugenia Olmedo García
- Contact Person Email
- mariaeugenia.olmedo@salud.madrid.org
- Site Name
- Hospital Clinico Universitario Lozano Blesa
- Department Name
- Oncología Médica
- Principal Investigator Name
- Maria Dolores Isla Casado
- Principal Investigator Email
- disla@salud.aragon.es
- Contact Person Name
- Maria Dolores Isla Casado
- Contact Person Email
- disla@salud.aragon.es
- Site Name
- Hospital Universitario 12 De Octubre
- Department Name
- Oncología Médica
- Principal Investigator Name
- Jon Zugazagoitia Fraile
- Principal Investigator Email
- j.zugazagoitia.imas12@h12o.es
- Contact Person Name
- Jon Zugazagoitia Fraile
- Contact Person Email
- j.zugazagoitia.imas12@h12o.es
- Site Name
- Hospital Universitario De Badajoz
- Department Name
- Oncología Médica
- Principal Investigator Name
- Marta González Cordero
- Principal Investigator Email
- marta.gonzalezc@salud-juntaex.es
- Contact Person Name
- Marta González Cordero
- Contact Person Email
- marta.gonzalezc@salud-juntaex.es
France
- Earliest CTIS Part Ii Submission Date
- 21-07-2025
- Latest Decision Or Authorization Date
- 19-02-2026
- Processing Time Days
- 213
- Number Of Sites
- 3
- Number Of Participants
- 60
Sites
- Site Name
- Centre Leon Berard
- Department Name
- Departement de Cancerologie Medicale
- Principal Investigator Name
- Philippe CASSIER
- Principal Investigator Email
- philippe.cassier@lyon.unicancer.fr
- Contact Person Name
- Philippe CASSIER
- Contact Person Email
- philippe.cassier@lyon.unicancer.fr
- Site Name
- Institut Bergonie
- Department Name
- Departement d'Oncologie Medicale
- Principal Investigator Name
- Antoine ITALIANO
- Principal Investigator Email
- a.italiano@bordeaux.unicancer.fr
- Contact Person Name
- Antoine ITALIANO
- Contact Person Email
- a.italiano@bordeaux.unicancer.fr
- Site Name
- Institut Gustave Roussy
- Department Name
- Departement Innovations Therapeutiques et Groupe Oncologie Genito-Urinaire
- Principal Investigator Name
- Yohann LORIOT
- Principal Investigator Email
- yohann.loriot@gustaveroussy.fr
- Contact Person Name
- Yohann LORIOT
- Contact Person Email
- yohann.loriot@gustaveroussy.fr
Sponsor
Primary sponsor
- Full Name
- Glaxosmithkline Research & Development Limited
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United Kingdom
Investigational products
- Investigational Product Name
- GSK5764227
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