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

  • STATUS
    Recruiting
  • End date
    May 15, 2023
  • participants needed
    80
  • sponsor
    Daiichi Sankyo, Inc.
Updated on 24 November 2021
platelet count
measurable disease
anticoagulants
vegf
growth factor
international normalized ratio
metastasis
oxaliplatin
neutrophil count
fluoropyrimidine
liver metastasis
irinotecan
bevacizumab
aptt
thromboplastin
solid tumour
vascular endothelial growth factor
microsatellite instability high

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.

Description

There will be 2 cohorts with enrollment in 2 parts. Participants will be treated on Day 1 of each 21-day cycle (every 3 weeks) with U3-1402 5.6 mg/kg intravenous (IV). The estimated treatment period is approximately 8 months and the follow-up period is approximately 4 months.

Details
Condition Metastatic Colorectal Cancer
Treatment U3-1402
Clinical Study IdentifierNCT04479436
SponsorDaiichi Sankyo, Inc.
Last Modified on24 November 2021

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