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drugset / Trial / NCT04479436

A Study to Evaluate U3-1402 in Subjects With Advanced or Metastatic Colorectal Cancer

NCT04479436 ↗

Phase 2 Terminated 40 enrolled Daiichi Sankyo
Non-randomizedParallel-groupOpen-labelTreatment

Summary

This study is designed to primarily evaluate the safety and efficacy of U3-1402 in participants with advanced or metastatic colorectal cancer (CRC) who have received at least 2 prior lines of therapy and will explore clinical benefit according to human epidermal growth factor receptor 3 (HER3) tumor expression level in otherwise refractory tumors.

Timeline

Start
2020-09-14
Primary completion
2022-02-03
Completion
2022-02-03

Outcome

Outcome not reported

Stopped: “Study was terminated early given the Interim Analysis for Part 1 (signal finding) did not meet pre-specified criteria and will not proceed to Part 2. Sponsor will proceed closing the study.”

Drugs

EvaluationDrugModalityDoseRoute
Subject Patritumab deruxtecan Monoclonal antibody 5.6 mg/kg Intravenous

Indications

colorectal cancer