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

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Daiichi Sankyo
Study ID
NCT06644781
Phase
PHASE3
Status
Recruiting
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Conditions

  • Esophageal Squamous Cell Carcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ifinatamab deruxtecan — DRUG
    Intravenous administration
  • Docetaxel — DRUG
    Intravenous administration
  • Paclitaxel — DRUG
    Intravenous administration
  • Irinotecan hydrochloride (HCl) — DRUG
    Intravenous administration

Study Details

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).

Key Dates

First listed
Oct 16, 2024
Start date
Mar 27, 2025
Status verified
Aug 2026
Primary completion
Jun 1, 2028
Completion
Nov 1, 2029

Study Design

Enrollment
510 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: I-DXd
    Participants who are randomized to receive an intravenous infusion of I-DXd 12 mg/kg on Day 1 of every 21-day cycle (Q3W).
  • Active Comparator: Investigator's Choice of Chemotherapy (ICC)
    Participants who are randomized to receive an intravenous infusion of investigator's choice of chemotherapy (docetaxel, paclitaxel, and irinotecan HCl).

Primary Outcome Measure

Overall Survival (OS) [ Time Frame: From the date of randomization to the date of death due to any cause, up to approximately 54 months ]

Central Contacts

Locations (13)

FacilityCityStateZIPSite coordinators
Mayo Clinic HospitalPhoenixArizona85054-
Providence Medical FoundationFullertonCalifornia92835-
Univ of California Irvine College of MedicineOrangeCalifornia92868-
Henry Ford Health SystemDetroitMichigan48202-
Mayo Clinic RochesterRochesterMinnesota55905-
MidAmerica Cancer Care - American Oncology PartnersKansas CityMissouri64132-
Morristown Medical CenterMorristownNew Jersey07960-
Maimonides Cancer CenterBrooklynNew York11220-
Penn State University Milton S. Hershey Medical CenterHersheyPennsylvania17033-
Baptist Cancer CenterMemphisTennessee38120-
SCRI Oncology PartnersNashvilleTennessee37203-
John Peter Smith HospitalFort WorthTexas76104-
Virginia Cancer SpecialistsFairfaxVirginia22031-

Find similar trials in Phoenix, AZ

By research site
Mayo Clinic Hospital· Phoenix, AZProvidence Medical Foundation· Fullerton, CAUniv of California Irvine College of Medicine· Orange, CAHenry Ford Health System· Detroit, MIMayo Clinic Rochester· Rochester, MNMidAmerica Cancer Care - American Oncology Partners· Kansas City, MO

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