NCT06644781

A Study of Ifinatamab Deruxtecan in Subjects With Pretreated Advanced or Metastatic Esophageal Squamous Cell Carcinoma (ESCC) (IDeate-Esophageal01)

A Phase 3, Multicenter, Randomized, Open-label Study of Ifinatamab Deruxtecan (I-DXd) in Subjects With Pretreated Advanced or Metastatic Esophageal Squamous Cell Carcinoma (ESCC) (IDeate-Esophageal01)

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 510 (estimated)
• Sponsor: Daiichi Sankyo · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is designed to assess the efficacy and safety of ifinatamab deruxtecan (I-DXd) in patients with unresectable advanced or metastatic esophageal squamous cell carcinoma (ESCC) who have experienced disease progression following treatment with a platinum-based systemic therapy and an immune checkpoint inhibitor (ICI) compared with investigator's choice of chemotherapy (ICC).

Detailed description

The primary objective of this study is to evaluate the overall survival (OS) benefit of I-DXd compared with investigator's choice of chemotherapy (ICC). The key secondary objectives of the study will evaluate the progression-free survival (PFS) and objective response rate (ORR) benefit of I-DXd compared with ICC.

Conditions

• Esophageal Squamous Cell Carcinoma

Interventions

Type	Name	Description
DRUG	Ifinatamab deruxtecan	Intravenous administration
DRUG	Docetaxel	Intravenous administration
DRUG	Paclitaxel	Intravenous administration
DRUG	Irinotecan hydrochloride (HCl)	Intravenous administration

Timeline

• Start date: 2025-03-27
• Primary completion: 2028-06-01
• Completion: 2029-11-01
• First posted: 2024-10-16
• Last updated: 2026-01-12

Locations

88 sites across 13 countries: United States, Belgium, China, France, Germany, Italy, Japan, Netherlands, Poland, Romania, South Korea, Spain, Taiwan

Regulatory

• FDA-regulated drug study