NCT04699630

A Study of U3-1402 (Patritumab Deruxtecan) in Subjects With Metastatic Breast Cancer

A Phase II Study of U3-1402 (Patritumab Deruxtecan) in Patients With Metastatic Breast Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 121 (actual)
• Sponsor: SCRI Development Innovations, LLC · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed 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.

Conditions

• Metastatic Breast Cancer
• Locally Advanced Breast Cancer

Interventions

Type	Name	Description
DRUG	U3-1402	All subjects will receive 5.6 mg/kg U3-1402 (Patritumab Deruxtecan) intravenously on day 1 of every 3 weeks. One cycle is defined as 3 weeks.

Timeline

• Start date: 2021-05-03
• Primary completion: 2025-04-09
• Completion: 2025-04-09
• First posted: 2021-01-07
• Last updated: 2025-12-22

Locations

11 sites across 1 country: United States

Regulatory

• FDA-regulated drug study