Clinical trial • Phase I • Oncology
GSK4381562 for Advanced solid tumour | Solid tumour
Phase I trial of GSK4381562 for Advanced solid tumour | Solid tumour. open-label, none/not specified-controlled. 126 participants.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Advanced solid tumour | Solid tumour
- Trial Stage
- Phase I
Key dates
- Initial CTIS Submission Date
- 26-03-2024
- First CTIS Authorization Date
- 14-05-2024
Trial design
open-label, none/not specified-controlled Phase I trial across 4 sites in France, Spain.
- Open Label
- Yes
- Comparator
- None/Not specified
- Target Sample Size
- 126
- Trial Duration For Participant
- 775
Eligibility
Recruits 126 Vulnerable population not selected (isVulnerablePopulationSelected=false); no specific consent/assent handling described in the record..
- Vulnerable Population
- Vulnerable population not selected (isVulnerablePopulationSelected=false); no specific consent/assent handling described in the record.
Recruitment
- Planned Sample Size
- 126
- Recruitment Window Months
- 51
Geography
- Total Number Of Sites
- 4
- Total Number Of Participants
- 32
France
- Latest Decision Or Authorization Date
- 04-06-2024
- Number Of Sites
- 2
- Number Of Participants
- 12
Sites
- Site Name
- Centr Georges Francois Leclerc
- Department Name
- Service d'Oncologie Médicale
- Contact Person Name
- François GHIRINGHELLI
- Contact Person Email
- fghiringhelli@cgfl.fr
- Site Name
- Centre Oscar Lambret
- Department Name
- Pôle d'Oncologie Médicale
- Contact Person Name
- Loïc LEBELLEC
- Contact Person Email
- l-lebellec@o-lambret.fr
Spain
- Latest Decision Or Authorization Date
- 21-01-2026
- Number Of Sites
- 2
- Number Of Participants
- 20
Sites
- Site Name
- Hospital Universitario Virgen De La Victoria
- Department Name
- Oncología
- Contact Person Name
- Javier García Corbacho
- Contact Person Email
- jgcorbacho@ibima.eu
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- Oncología
- Contact Person Name
- Alberto Hernando Calvo
- Contact Person Email
- ahernando@vhio.net
Sponsor
Primary sponsor
- Full Name
- Glaxosmithkline Research & Development Limited
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United Kingdom
Investigational products
- Investigational Product Name
- GSK4381562
- First In Human
- Yes
- Combination Treatment
- Yes
Related trials
Other published trials that may interest you.
- AD-O51.4 for Advanced solid tumour | Solid tumour
- GDC-9545 for Locally advanced or metastatic estrogen receptor-positive breast cancer
- Abemaciclib for Stage IV lung cancer | Breast cancer
- BGB-43395 for Advanced or metastatic solid tumors | Hormone receptor positive HER2 negative breast cancer
- AZD9833 for Estrogen receptor-positive HER2-negative advanced breast cancer