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

Daiichi Sankyo
NCT IDNCT06644781ClinicalTrials.gov data as of Apr 2026
Phase

Phase 3

Target enrollment

510

Study length

about 4.6 years

Ages

18+

Locations

6 sites in CA, MI, TN +2

What this study is about

Researchers are testing if a treatment called ifinatamab deruxtecan, given with chemotherapy, can help people who have advanced esophageal squamous cell carcinoma. The trial will compare this new treatment to standard chemotherapy options.

Simplified from trial records by PatientMatch.

What you may be asked to do

  • 1.Take Docetaxel
  • 2.Take Ifinatamab deruxtecan
  • 3.Take Irinotecan hydrochloride (HCl)
  • +1 more

Participation Burden

What's physically and logistically required of participants.

Logistics & Travel
In-person visits

Requires travel to a study site

Physical Intervention
Injection / IVInjection / IV

How treatment is administered

Treatment Assignment
Randomized (Open Label)

You are randomly assigned, but you will know your treatment.

Extracted study details

Pulled from the trial record to show what is being tested and what the study is measuring.

Drug classes

docetaxel, Antineoplastic Agent [TC] (Topoisomerase Inhibitors), paclitaxel (Taxane chemotherapy; stabilizes microtubules)

Drug routes

infusion, injection, intravenous

Endpoints

Primary: Overall Survival (OS)

Secondary: Change from baseline in European Organisation for Research and Treatment of Cancer Core Quality of Life Questionnaire Score (EORTC QLQ-C30), Change from baseline in European Organisation for Research and Treatment of Cancer Esophageal Cancer Module Score (EORTC OES18), Disease Control Rate (DCR), Duration of Response (DoR), Incidence of Treatment-emergent Adverse Events (TEAEs), Serious TEAEs, and Adverse Events of Special Interest (AESIs), Objective Response Rate (ORR), Pharmacokinetic Parameter Time to Maximum Concentration (Tmax) for I-DXd, Pharmacokinetic Parameter Time to Maximum Concentration (Tmax) for MAAA-1181a

Body systems

Oncology