Clinical trial • Phase I/II • Oncology
BYON4228 for Locally advanced or metastatic solid tumours
Phase I/II trial of BYON4228 for Locally advanced or metastatic solid tumours. adaptive. 63 participants.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Locally advanced or metastatic solid tumours
- Trial Stage
- Phase I/II
Key dates
- Initial CTIS Submission Date
- 27-01-2025
- First CTIS Authorization Date
- 30-04-2025
Trial design
adaptive Phase I/II trial across 6 sites in Spain, Belgium.
- Adaptive
- True - dose-escalation/expansion design (escalation cohorts and expansion cohorts indicated by title)
- Single Multiple Or Escalation Dose Combined
- Yes
- Target Sample Size
- 63
Eligibility
Recruits 63 No vulnerable population selected.
- Vulnerable Population
- No vulnerable population selected
Recruitment
- Planned Sample Size
- 63
- Recruitment Window Months
- 33
Geography
- Total Number Of Sites
- 6
- Total Number Of Participants
- 63
Spain
- Earliest CTIS Part Ii Submission Date
- 16-04-2025
- Latest Decision Or Authorization Date
- 30-04-2025
- Processing Time Days
- 14
- Number Of Sites
- 4
- Number Of Participants
- 33
Sites
- Site Name
- Hospital Universitario Hm Sanchinarro
- Department Name
- Medical Oncology
- Contact Person Name
- Emiliano Calvo Aller
- Contact Person Email
- emiliano.calvo@startmadrid.com
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- Medical Oncology
- Contact Person Name
- María Julia Lostes Bardají
- Contact Person Email
- mariajulia.lostes@vallhebron.cat
- Site Name
- Hospital Universitario Fundacion Jimenez Diaz
- Department Name
- Medical Oncology
- Contact Person Name
- Bernard Doger de Speville Uribe
- Contact Person Email
- bernard.doger@startmadrid.com
- Site Name
- Institut Catala D'oncologia
- Department Name
- Medical Oncology
- Contact Person Name
- Agostina Stradella
- Contact Person Email
- astradella@iconcologia.net
Belgium
- Earliest CTIS Part Ii Submission Date
- 15-04-2025
- Latest Decision Or Authorization Date
- 05-05-2025
- Processing Time Days
- 20
- Number Of Sites
- 2
- Number Of Participants
- 30
Sites
- Site Name
- Institut Jules Bordet
- Department Name
- Medical Oncology
- Contact Person Name
- Nuria Kotecki
- Contact Person Email
- nuria.kotecki@hubruxelles.be
- Site Name
- UZ Leuven
- Department Name
- Medical Oncology
- Contact Person Name
- Oliver Bechter
- Contact Person Email
- oliver.bechter@uzleuven.be
Sponsor
Primary sponsor
- Full Name
- Byondis B.V.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Netherlands
Investigational products
- Investigational Product Name
- BYON4228
- Combination Treatment
- Yes
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