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Clinical Trial Summary

This study is to evaluate safety and efficacy of an antibody drug conjugate U3-1402 (patritumab deruxtecan) in patients with locally advanced or metastatic breast cancer (MBC).


Clinical Trial Description

U3-1402 (Patritumab Deruxtecan) is an antibody drug conjugate comprising a recombinant fully human anti HER3 monoclonal antibody linked to a linker containing topoisomerase I inhibitor. This is a phase II study of U3-1402 (patritumab deruxtecan) in subjects with MBC. The study will be conducted in 3 parts (Part A , Part B, and Part Z). All enrolled subjects in Part A will undergo pretreatment biopsies to determine if subjects with particular biomarker expression (ER/PR/HER2/HER3) show preliminary efficacy. Part B will enroll subgroups of participants that are metastatic, hormone receptor-positive (HR+) HER2-negative or triple-negative (mTNBC) regardless of HER3 expression that were defined from Part A analysis. Part Z will enroll participants with HER2- positive (HER2+) MBC. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04699630
Study type Interventional
Source SCRI Development Innovations, LLC
Contact Sarah Cannon Development Innovations, LLC
Phone 844-710-6157
Email SCRI.InnovationsMedical@scri.com
Status Recruiting
Phase Phase 2
Start date May 3, 2021
Completion date November 2025

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