Clinical trial • Phase I • Oncology
SOT201 for Advanced/metastatic solid tumors
Phase I trial of SOT201 for Advanced/metastatic solid tumors. 32 participants.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Advanced/metastatic solid tumors
- Trial Stage
- Phase I
Key dates
- Initial CTIS Submission Date
- 07-12-2023
- First CTIS Authorization Date
- 17-04-2024
Trial design
Phase I trial across 4 sites in Belgium, Czechia, Spain.
- Target Sample Size
- 32
Eligibility
Recruits 32 Vulnerable population selected (isVulnerablePopulationSelected=true); no details on consent or assent provided in the record..
- Vulnerable Population
- Vulnerable population selected (isVulnerablePopulationSelected=true); no details on consent or assent provided in the record.
Recruitment
- Planned Sample Size
- 32
- Recruitment Window Months
- 29
Geography
- Total Number Of Sites
- 4
- Total Number Of Participants
- 32
Belgium
- Earliest CTIS Part Ii Submission Date
- 15-03-2024
- Latest Decision Or Authorization Date
- 05-05-2026
- Processing Time Days
- 781
- Number Of Sites
- 2
- Number Of Participants
- 12
Sites
- Site Name
- Antwerp University Hospital
- Department Name
- Oncology
- Contact Person Name
- Hans Prenen
- Contact Person Email
- Hans.Prenen@uza.be
- Site Name
- Institut Jules Bordet
- Department Name
- Oncology
- Contact Person Name
- Nuria Kotecki
- Contact Person Email
- nuria.kotecki@hubruxelles.be
Czechia
- Earliest CTIS Part Ii Submission Date
- 18-03-2024
- Latest Decision Or Authorization Date
- 09-04-2026
- Processing Time Days
- 752
- Number Of Sites
- 1
- Number Of Participants
- 12
Sites
- Site Name
- Masarykuv Onkologicky Ustav
- Department Name
- Oddělení klinické onkologie
- Contact Person Name
- Radka Lordick Obermannová
- Contact Person Email
- obermannova@mou.cz
Spain
- Earliest CTIS Part Ii Submission Date
- 29-01-2024
- Latest Decision Or Authorization Date
- 16-04-2026
- Processing Time Days
- 808
- Number Of Sites
- 1
- Number Of Participants
- 8
Sites
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- Oncology
- Contact Person Name
- Elena Garralda Cabanas
- Contact Person Email
- egarralda@vhio.net
Sponsor
Primary sponsor
- Full Name
- SOTIO Biotech AG
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Switzerland
Investigational products
- Investigational Product Name
- SOT201
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