DS7300-202
Research type
Research Study
Full title
A PHASE 3, MULTICENTER, RANDOMIZED, OPEN LABEL STUDY OF IFINATAMAB DERUXTECAN (I-DXD) IN SUBJECTS WITH PRETREATED ADVANCED OR METASTATIC ESOPHAGEAL SQUAMOUS CELL CARCINOMA (ESCC) (IDeate Esophageal01)
IRAS ID
1010585
Contact name
Bettina Steffens
Contact email
Sponsor organisation
Daiichi Sankyo, Inc.
Eudract number
2023-509630-19
Clinicaltrials.gov Identifier
Research summary
This is a global, multicenter, randomised, open-label, Phase 3 study of adult subjects 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). Subjects in this study must have received no more than 1 prior line of systemic therapy for unresectable advanced or metastatic ESCC.
This study is designed to randomize (randomly assign) 510 subjects in a 1:1 ratio to receive the study drug Ifinatamab Deruxtecan (I DXd) at 12 mg/kg or the investigator’s choice of chemotherapy [ICC] (paclitaxel, docetaxel, or irinotecan hydrochloride [HCI]).
The study will be divided into 3 periods: Screening, Treatment, and Follow-up (which includes the 40-day Safety Follow-up and the Long term Follow-up Periods.
The study will take place in the USA, Europe, and Asia, including China and Japan.
Enrolment is planned to occur over approximately 28 months from the enrollment of the first subject.
Anticipated total duration of the study is approximately 54 months.
The investigational drug, I-DXd, is being developed by the Sponsor, Daiichi Sankyo, Inc.REC name
East Midlands - Nottingham 2 Research Ethics Committee
REC reference
25/EM/0141
Date of REC Opinion
26 Aug 2025
REC opinion
Further Information Favourable Opinion