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

NCT06644781 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 510

Last updated 2026-01-12

No results posted yet for this study

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).

Conditions

Interventions

DRUG

Ifinatamab deruxtecan

Intravenous administration

DRUG

Docetaxel

Intravenous administration

DRUG

Paclitaxel

Intravenous administration

DRUG

Irinotecan hydrochloride (HCl)

Intravenous administration

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-27
Primary Completion
2028-06-01
Completion
2029-11-01
FDA Drug
Yes

Countries

  • United States
  • Belgium
  • China
  • France
  • Germany
  • Italy
  • Japan
  • Netherlands
  • Poland
  • Romania
  • South Korea
  • Spain
  • Taiwan

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06644781 on ClinicalTrials.gov