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Brief Title: A First-in-human Dose-escalation and Expansion Study With the Antibody-drug Conjugate BYON3521
Official Title: A First-in-human Dose-escalation and Expansion Trial With the Antibody-drug Conjugate BYON3521 to Evaluate the Safety, Pharmacokinetics and Efficacy in Patients With c-MET Expressing Locally Advanced or Metastatic Solid Tumours
Study ID: NCT05323045
Brief Summary: 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.
Detailed Description: 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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Institut Jules Bordet, Brussels, , Belgium
Istituto Europeo di Oncologia, Milan, , Italy
Radboud, Nijmegen, , Netherlands
Royal Marsden, London, , United Kingdom
Name: Tanya Vermaas
Affiliation: Byondis B.V., The Netherlands
Role: STUDY_DIRECTOR