Actively Recruiting
Phase 3 Study of Ifinatamab Deruxtecan vs Chemotherapy in Advanced or Metastatic Esophageal Squamous Cell Carcinoma
Led by Daiichi Sankyo · Updated on 2026-08-04
510
Participants Needed
132
Research Sites
74 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are studying ifinatamab deruxtecan I-DXd in adults with advanced or metastatic esophageal squamous cell carcinoma ESCC that cannot be surgically removed and who have seen their disease worsen after treatment with platinum-based chemotherapy and immune checkpoint inhibitors. The study aims to compare I-DXd with chemotherapy chosen by the investigator to evaluate overall survival and other key outcomes. Participants will be randomly assigned to receive either I-DXd given through an intravenous infusion at 12 mgkg every 21 days or one of several chemotherapy drugs docetaxel, paclitaxel, or irinotecan hydrochloride administered intravenously. The study will continue to assess these treatments throughout multiple 21-day cycles. During the trial, participants will be monitored for overall survival, progression-free survival, tumor response, and quality of life using questionnaires. Safety will be closely tracked by recording adverse events and measuring drug levels in the blood. The study may last up to approximately 54 months for each participant, with regular assessments including imaging scans and laboratory tests to follow the disease and treatment effects.
CONDITIONS
Brief Title
A Study of Ifinatamab Deruxtecan in Subjects With Pretreated Advanced or Metastatic Esophageal Squamous Cell Carcinoma (ESCC) (IDeate-Esophageal01)
Research Team
D
Daiichi Sankyo Contact for Clinical Trial Information
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