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

StatusRecruiting
PhasePhase 3
Started2025-03-27
View on ClinicalTrials.gov ↗

Amendment history

2026-08-03
Study Status, Contacts/Locations v8
Trial sites expanded: 88 → 132 locations
2026-01-09
Study Status, Contacts/Locations v7
Study sites46→88
2025-09-15
Study Status, Contacts/Locations v6
Study sites20→46
2025-07-10
Study Status, Contacts/Locations v5
Study sites15→20
2025-06-06
Study Status, Contacts/Locations v4
Study sites9→15
Show 3 earlier versions
2025-05-13
Study Status, Contacts/Locations v3
Study sites6→9
2025-04-17
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2025-02-28→confirmed 2025-03-27
Study sites0→6
2025-01-15
Study Identification, Study Status, Study Description, Conditions, Arms and Interventions, Outcome Measures, Eligibility v1
Primary completion date2029-05-30→2028-06-01
Completion date2029-10-30→2029-11-01
InterventionsDocetaxel (Drug), Ifinatamab deruxtecan (Drug), Irinotecan (Drug), Paclitaxel (Drug)→Docetaxel (Drug), Ifinatamab deruxtecan (Drug), Irinotecan hydrochloride (HCl) (Drug), Paclitaxel (Drug)
Eligibility criteria-1,015 characters
[...] g criteria to be eligible for randomization into the study: Sign and date the informed consent form (ICF) prior to the start of any study-specific qualification procedures. Participants aged ≥18 years (follow local regulatory require [...] dition staging system on ESCC. Has disease progression post a platinum-based chemotherapy and an ICI treatment per global or local guidelines, with a maximu [...] an ECOG PS of 0 or 1 within 7 days prior to Cycle 1 Day 1. Has required baseline local laboratory data within 7 days prior to the start of study drug administration. Transfusion (red blood cell or platelet) or [...] [...]
Secondary endpointsdetails revised at 9 of 11 entries
Study title+48 characters
A Study of Ifinatamab Deruxtecan in Subjects With Pretreated Advanced or Metastatic Esophageal Squamous Cell Carcinoma (ESCC) (IDeate-Esophageal01)
2024-10-14
Original filing
Daiichi Sankyo
69 trials monitored
See 8 trials at risk
Esophageal Cancer
1,010 trials monitored
See 51 trials at risk
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).
Trial Details
NCT Number NCT06644781
Lead Sponsor Daiichi Sankyo
Collaborators: Merck Sharp & Dohme LLC
Conditions Esophageal Squamous Cell Carcinoma
Enrollment 510 participants
Start Date 2025-03-27
Primary Completion 2028-06-01 (estimated)
Study Completion 2029-11-01 (estimated)
Updated on ClinicalTrials.gov 2026-08-04