A Study of U3-1402 in Subjects With Metastatic Breast Cancer
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Metastatic Breast Cancer
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: Non-RandomizedIntervention Model: Sequential AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
U3-1302 is an antibody drug conjugate comprising a recombinant fully human anti HER3 monoclonal antibody linked to a linker containing topoisomerase I inhibitor. This study is a phase II study of U3-1402 in subjects with MBC who have received no prior anti HER2 therapy. The study will be conducted i...
U3-1302 is an antibody drug conjugate comprising a recombinant fully human anti HER3 monoclonal antibody linked to a linker containing topoisomerase I inhibitor. This study is a phase II study of U3-1402 in subjects with MBC who have received no prior anti HER2 therapy. The study will be conducted in 2 parts (Part A and Part B). 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 after an analysis is performed at 24 weeks. Part B will enroll subgroups of subjects that will be defined from part A based on ER/PR/HER2/HER3 expression and will be evaluated for efficacy analysis.
Tracking Information
- NCT #
- NCT04699630
- Collaborators
- Daiichi Sankyo, Inc.
- Investigators
- Study Chair: Erika Hamilton, MD SCRI Development Innovations, LLC
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