This is the first-in-human trial with BYON3521, an antibody-drug conjugate (ADC) comprising a humanized IgG1 monoclonal antibody directed against the c-MET receptor covalently conjugated to a duocarmycin-containing linker-drug.
This trial includes a dose-escalation part (Part 1) in which the MTD and RDE will be determined, and an expansion part (Part 2) to evaluate efficacy and safety in specific patient cohorts. BYON3521 is an ADC comprising a humanized IgG1 monoclonal antibody (mAb) directed against the c-MET receptor covalently and site-specifically conjugated to a duocarmycin-containing linkerdrug.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
31
BYON3521 (in the vein) infusion every three weeks. Number of cycles: until cancer progression or unacceptable toxicity develops. Different doses.
Institut Jules Bordet
Brussels, Belgium
Istituto Europeo di Oncologia
Milan, Italy
Radboud
Nijmegen, Netherlands
Royal Marsden
London, United Kingdom
Incidence of dose-limiting toxicities
Part 1
Time frame: 21 days
Objective response rate
Part 2
Time frame: 21 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.