Last reviewed · How we verify

NCT06644781

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

Recruiting now Phase 3 Last updated 12 January 2026
What this trial tests

Phase 3 trial testing Ifinatamab deruxtecan in Esophageal Squamous Cell Carcinoma in 510 participants. Currently enrolling.

Timeline
27 March 2025
Primary endpoint
1 June 2028
1 November 2029

Quick facts

Lead sponsorDaiichi Sankyo
PhasePhase 3
StatusRecruiting now
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment510
Start date27 March 2025
Primary completion1 June 2028
Estimated completion1 November 2029
Sites88 locations across France, Italy, Japan, Netherlands, Belgium, Taiwan, Germany, Poland

Drugs / interventions tested

Conditions studied

Sponsor

Daiichi Sankyo — full company profile →

Who can join

18 and older, any sex, with Esophageal Squamous Cell Carcinoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Antibody-Drug Conjugates (ADCs): current and future biopharmaceuticals.
    Wang R, Hu B, Pan Z, Mo C, et al · · 2025 · cited 105× · PMID 40307936 · DOI 10.1186/s13045-025-01704-3
  2. Antibody-drug conjugates in cancer therapy: current advances and prospects for breakthroughs.
    Wu D, Yang K, He R, Yin R, et al · · 2025 · cited 2× · PMID 41133214 · DOI 10.3389/fcell.2025.1669592
  3. Frontiers in Antibody-Drug Conjugates: Mechanisms, Design Innovations, and Clinical Applications in Targeted Cancer Therapy.
    Li X, Liu J, Meng Y, Li J, et al · · 2026 · PMID 41754865 · DOI 10.3390/ph19020324
  4. Antibodies to watch in 2026.
    Crescioli S, Kaplon H, Chenoweth A, Hsu YS, et al · · 2026 · PMID 41560619 · DOI 10.1080/19420862.2026.2614669
  5. Changing landscape of advanced esophageal squamous cell carcinoma: Breakthroughs in systemic therapies (Review).
    Li Y, Li J, Mo W, Xu X. · · 2025 · PMID 40682837 · DOI 10.3892/or.2025.8953
  6. Immune-checkpoint targeting drug conjugates: a novel class of promising therapeutic agents for cancer treatment.
    Marchesi S, Marinello A, Ambrosini P, Cavalli C, et al · · 2025 · PMID 40603576 · DOI 10.1038/s41698-025-01011-7

Verify or expand the search:

Other trials of Ifinatamab deruxtecan

Trials testing the same drug.

Other recruiting trials for Esophageal Squamous Cell Carcinoma

Currently open trials in the same condition.

Other Daiichi Sankyo trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06644781.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing