drugset / Trial / NCT06644781

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

NCT06644781

Phase 3 Recruiting 510 enrolled Daiichi Sankyo Merck Sharp & Dohme LLC · collab
RandomizedParallel-groupOpen-labelTreatment

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).

Timeline

Start
2025-03-27
Primary completion
2028-06-01
Completion
2029-11-01

Drugs

EvaluationDrugModalityDoseRoute
Comparator Docetaxel Small molecule Intravenous
Subject Ifinatamab Deruxtecan Other / unclassified 12 mg/kg Intravenous
Comparator Irinotecan hydrochloride (HCl) Unknown Intravenous
Comparator Paclitaxel Small molecule Intravenous