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NCT06644781
A Study of Ifinatamab Deruxtecan in Subjects With Pretreated Advanced or Metastatic Esophageal Squamous Cell Carcinoma (ESCC) (IDeate-Esophageal01)
Phase 3 trial testing Ifinatamab deruxtecan in Esophageal Squamous Cell Carcinoma in 510 participants. Currently enrolling.
1 June 2028
Quick facts
| Lead sponsor | Daiichi Sankyo |
|---|---|
| Phase | Phase 3 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 510 |
| Start date | 27 March 2025 |
| Primary completion | 1 June 2028 |
| Estimated completion | 1 November 2029 |
| Sites | 88 locations across France, Italy, Japan, Netherlands, Belgium, Taiwan, Germany, Poland |
Drugs / interventions tested
- Ifinatamab deruxtecan — full drug profile →
- Docetaxel (Docetaxel) — full drug profile →
- Paclitaxel — full drug profile →
- Irinotecan hydrochloride (HCl)
Conditions studied
- Esophageal Squamous Cell Carcinoma — all drugs for Esophageal Squamous Cell Carcinoma →
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):
-
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 -
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 -
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 -
Antibodies to watch in 2026.
Crescioli S, Kaplon H, Chenoweth A, Hsu YS, et al · · 2026 · PMID 41560619 · DOI 10.1080/19420862.2026.2614669 -
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 -
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:
- PubMed search for NCT06644781
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Ifinatamab deruxtecan
Trials testing the same drug.
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- NCT06362252 — A Study of I-DXd in Combination With Atezolizumab With or Without Carboplatin as First-Line Induction or Maintenance in · Phase 1, PHASE2 · recruiting
- NCT06203210 — A Study of Ifinatamab Deruxtecan Versus Treatment of Physician's Choice in Subjects With Relapsed Small Cell Lung Cancer · Phase 3 · recruiting
- NCT06330064 — A Study To Evaluate The Efficacy And Safety Of Ifinatamab Deruxtecan (I-DXd) In Subjects With Recurrent Or Metastatic So · Phase 2 · recruiting
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Currently open trials in the same condition.
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Other Daiichi Sankyo trials
Trials by the same sponsor.
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- NCT07268625 — Evaluating Bioequivalence of a Fixed Dose Combination Versus Individual Tablets of Bempedoic Acid / Ezetimibe, and Atorv · Phase 1 · completed
- NCT07244341 — A Study of Valemetostat (DS-3201b) in Combination With Darolutamide in Metastatic Castration Resistant Prostate Cancer ( · Phase 1 · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06644781 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Daiichi Sankyo
- Last refreshed: 12 January 2026
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