NCT04479436

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

A Multi-Center, Open-Label, Phase 2 Study to Evaluate Safety and Efficacy of U3-1402 in Subjects With Advanced or Metastatic Colorectal Cancer (CRC)

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Daiichi Sankyo · Industry
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Metastatic Colorectal Cancer

Interventions

Type	Name	Description
DRUG	Patritumab Deruxtecan	U3-1402 will be dosed at 5.6 mg/kg as an intravenous (IV) infusion administered on Day 1 of each 21-day cycle.

Timeline

• Start date: 2020-09-14
• Primary completion: 2022-02-03
• Completion: 2022-02-03
• First posted: 2020-07-21
• Last updated: 2025-05-18
• Results posted: 2025-05-18

Locations

46 sites across 8 countries: United States, Belgium, France, Italy, Japan, Poland, Spain, United Kingdom

Regulatory

• FDA-regulated drug study