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Spots Global Cancer Trial Database for A First-in-human Dose-escalation and Expansion Study With the Antibody-drug Conjugate BYON3521

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Trial Identification

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

Conditions

Solid Tumor

Interventions

BYON3521

Study Description

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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Institut Jules Bordet, Brussels, , Belgium

Istituto Europeo di Oncologia, Milan, , Italy

Radboud, Nijmegen, , Netherlands

Royal Marsden, London, , United Kingdom

Contact Details

Name: Tanya Vermaas

Affiliation: Byondis B.V., The Netherlands

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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