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A First-in-human Dose-escalation and Expansion Study With the Antibody-drug Conjugate BYON3521

NCT05323045 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2025-07-09

No results posted yet for this study

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.

Conditions

Interventions

DRUG

BYON3521

BYON3521 (in the vein) infusion every three weeks. Number of cycles: until cancer progression or unacceptable toxicity develops. Different doses.

Sponsors & Collaborators

  • Byondis B.V.

    lead INDUSTRY

Principal Investigators

  • Tanya Vermaas · Byondis B.V., The Netherlands

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-21
Primary Completion
2024-03-04
Completion
2024-09-25

Countries

  • Belgium
  • Italy
  • Netherlands
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05323045 on ClinicalTrials.gov