Overview

A Window-of-opportunity Study of U3-1402, a HER3-targeting Antibody-drug Conjugate in Operable Breast Cancer According to ERBB3 Expression

Status:
Recruiting

Trial end date:
2022-04-30

Target enrollment:

Participant gender:

Summary

Trial design This is a prospective, multicenter, single-arm, window-of-opportunity study evaluating the biological effect of patritumab deruxtecan in treatment naïve patients with HR-positive/HER2-negative early breast cancer, whose primary tumors are ≥1 cm by ultrasound evaluation. Patients will be enrolled in four cohorts according to the mRNA-based ERBB3 expression by central assessment. The objective of the study is to evaluate biological activity of patritumab deruxtecan in patients with treatment naïve early breast cancer. The primary endpoint is CelTIL score after one single-dose of U3-1402. A translational research plan is also included to provide biological information and to evaluate secondary and exploratory objectives of the study.

Phase:

Early Phase 1

Details

Lead Sponsor:

SOLTI Breast Cancer Research Group

Collaborator:

Daiichi Sankyo, Inc.

Treatments:

Patritumab deruxtecan