A Study of Ifinatamab Deruxtecan in Subjects With Pretreated Advanced or Metastatic Esophageal Squamous Cell Carcinoma (ESCC) (IDeate-Esophageal01)
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)
2 other identifiers
interventional
510
13 countries
88
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Mar 2025
Longer than P75 for phase_3
88 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 10, 2024
CompletedFirst Posted
Study publicly available on registry
October 16, 2024
CompletedStudy Start
First participant enrolled
March 27, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 1, 2029
January 12, 2026
January 1, 2026
3.2 years
October 10, 2024
January 9, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall Survival (OS)
Overall Survival (OS) is defined as the time interval from the date of randomization to the date of death due to any cause.
From the date of randomization to the date of death due to any cause, up to approximately 54 months
Secondary Outcomes (11)
Progression-free survival (PFS)
From the date of randomization to the date of disease progression or death due to any cause, whichever occurs first, up to approximately 54 months
Objective Response Rate (ORR)
From the time of first dose of study drug until date of documented disease progression or death, whichever occurs first, up to approximately 54 months
Duration of Response (DoR)
From the time of the first dose of study drug until the date of documented disease progression (as assessed by BICR) or death due to any cause, up to approximately 54 months
Disease Control Rate (DCR)
From the time of the first dose of study drug until the date of documented disease progression (as assessed by BICR) or death due to any cause, up to approximately 54 months
Change from baseline in European Organisation for Research and Treatment of Cancer Core Quality of Life Questionnaire Score (EORTC QLQ-C30)
Baseline up to 54 months
- +6 more secondary outcomes
Study Arms (2)
I-DXd
EXPERIMENTALParticipants who are randomized to receive an intravenous infusion of I-DXd 12 mg/kg on Day 1 of every 21-day cycle (Q3W).
Investigator's Choice of Chemotherapy (ICC)
ACTIVE COMPARATORParticipants who are randomized to receive an intravenous infusion of investigator's choice of chemotherapy (docetaxel, paclitaxel, and irinotecan HCl).
Interventions
Intravenous administration
Eligibility Criteria
You may qualify if:
- Participants must meet all of the following criteria to be eligible for randomization into the study:
- Participants aged ≥18 years (follow local regulatory requirements if the legal age of consent for study participation is \>18 years old).
- Has histologically or cytologically documented unresectable locally advanced or metastatic ESCC according to American Joint Committee on Cancer 8th edition staging system on ESCC.
- Has disease progression post a platinum-based chemotherapy and an ICI treatment per global or local guidelines, with a maximum of 1 prior line of systemic therapy for unresectable advanced or metastatic ESCC.
- The participant must provide adequate baseline tumor samples with sufficient quantity and quality of tumor tissue content as defined in the Laboratory Manual.
- Has at least 1 measurable lesion on computed tomography (CT)/magnetic resonance imaging (MRI) according to RECIST v1.1 as assessed by the investigator. Measurable lesions should not be from a previously irradiated site. If the lesion at a previously irradiated site is the only selectable target lesion, a radiological assessment showing significant progression of the irradiated lesion should be provided by the investigator.
- Has an ECOG PS of 0 or 1 within 7 days prior to Cycle 1 Day 1.
You may not qualify if:
- Participants who meet any of the following criteria will be disqualified from entering the study:
- Has received prior treatment with orlotamab, enoblituzumab, or other B7-H3 targeted agents, including I-DXd.
- Has received any topoisomerase inhibitor.
- Has histologically or cytologically confirmed adenosquamous carcinoma subtype.
- Is ineligible to all the chemotherapies in the comparator arm due to prior progression or intolerance.
- Has tumor invasion into organs located adjacent to the esophageal disease site (eg, aorta or respiratory tract) at an increased risk of bleeding or fistula as assessed by the investigator.
- Clinically active brain metastases, spinal cord compression, or leptomeningeal carcinomatosis, defined as untreated or symptomatic, or requiring therapy with steroids or anticonvulsants to control associated symptoms. Subjects with clinically inactive or treated brain metastases who are asymptomatic (ie, without neurologic signs or symptoms and not requiring treatment with corticosteroids or anticonvulsants) may be included in the study. Subjects must have a stable neurologic status and discontinue corticosteroid usage for at least 2 weeks prior to Screening.
- Has any of the following within the past 6 months: cerebrovascular accident, transient ischemic attack, other arterial thromboembolic event, or pulmonary embolism.
- Has a clinically significant corneal disease.
- Has a history of (non-infectious) interstitial lung disease (ILD)/pneumonitis that required corticosteroids, current ILD/pneumonitis, or suspected ILD/pneumonitis that cannot be ruled out by imaging at Screening.
- Has clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses, including, but not limited to, any underlying pulmonary disorder (ie, pulmonary emboli within 3 months of the study randomization, severe asthma, chronic obstructive pulmonary disease \[COPD\], restrictive lung disease, pleural effusion, etc), and potential pulmonary involvement caused by any autoimmune, connective tissue, or inflammatory disorders (eg, rheumatoid arthritis, Sjögren's syndrome, sarcoidosis, etc), prior pneumonectomy, or requirement for supplemental oxygen.
- Is on chronic steroid treatment (dose of 10 mg daily or more prednisone equivalent), except for low-dose inhaled steroids (for asthma/COPD), topical steroids (for mild skin conditions), or intra-articular steroid injections.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Daiichi Sankyolead
- Merck Sharp & Dohme LLCcollaborator
Study Sites (88)
Providence Medical Foundation
Fullerton, California, 92835, United States
Henry Ford Health System
Detroit, Michigan, 48202, United States
Baptist Cancer Center
Memphis, Tennessee, 38120, United States
SCRI Oncology Partners
Nashville, Tennessee, 37203, United States
John Peter Smith Hospital
Fort Worth, Texas, 76104, United States
Virginia Cancer Specialists
Fairfax, Virginia, 22031, United States
Institut Jules Bordet
Brussels, 1070, Belgium
Cliniques Universitaires Saint-Luc
Brussels, 1200, Belgium
Antwerp University Hospital
Edegem, 2650, Belgium
UZ Leuven
Leuven, 3000, Belgium
Anyang Cancer Hospital
Anyang, 455000, China
Beijing Cancer Hospital
Beijing, 100142, China
Jilin Cancer Hospital
Changchun, 130000, China
Changzhou Cancer Hospital
Changzhou, 213001, China
Sichuan cancer hospital
Chengdu, 610041, China
West China Hospital Sichuan University
Chengdu, 610041, China
Fujian Cancer Hospital
Fuzhou, 350015, China
Harbin Medical University Cancer Hospital
Harbin, 150081, China
The First Affiliated Hospital of Fujian Medical University
Hefei, 230088, China
Jinan Central Hospital
Jinan, 250013, China
Shandong Cancer Hospital
Jinan, 250117, China
Affiliated Hospital of Jining Medical University
Jining, 272029, China
Guangxi Medical University Affiliated Tumor Hospital
Nanning, 530021, China
Liaoning Cancer Hospital and Institute
Shenyang, 110042, China
Tianjin Medical University Cancer Institute and Hospital
Tianjin, 453000, China
The First Affiliated Hospital of Xinxiang Medical University
Weihui, 453100, China
Hubei Cancer Hospital
Wuhan, 430000, China
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, 430022, China
Zhongshan Hospital Xiamen University
Xiamen, 361004, China
Subei Peoples Hospital
Yangzhou, 225001, China
Sainte Catherine Institut du cancer Avignon en Provence
Avignon, 84918, France
CHU Brest - Hôpital de la Cavale Blanche
Brest, 29609, France
Institut Régional du Cancer de Montpellier
Montpellier, 34298, France
Hôpital Européen Georges Pompidou
Paris, 75015, France
CHU Poitiers - Hôpital la Milétrie
Poitiers, 86000, France
Unité de recherche clinique ICANS
Strasbourg, 67033, France
CHU Toulouse Rangueil Service dOncologie médicale
Toulouse, 31059, France
Krankenhaus Nordwest GmbH
Frankfurt am Main, 60488, Germany
Hämatologisch Onkologische Praxis Eppendorf HOPE
Hamburg, 20249, Germany
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, 20133, Italy
Azienda Ospedaliera Universitaria Luigi Vanvitelli
Naples, 80131, Italy
IOV - Istituto Oncologico Veneto IRCCS
Padua, 35128, Italy
Fondazione Policlinico Gemelli
Rome, 00168, Italy
National Cancer Center Hospital
Chūōku, 104-0045, Japan
Hiroshima University Hospital
Hiroshima, 734-8551, Japan
National Cancer Center Hospital East
Kashiwa, 277-8577, Japan
Kagawa University Hospital
Kita-gun, 761-0793, Japan
Kobe City Hospital Organization Kobe City Medical Center General Hospital
Kobe, 650-0047, Japan
Cancer Institute Hospital of JFCR
Kōtoku, 135-8550, Japan
Shikoku Cancer Center
Matsuyama, 791-0280, Japan
Aichi Cancer Center
Nagoya, 464-8681, Japan
Osaka International Cancer Institute
Osaka, 541-8567, Japan
Kindai University Hospital
Ōsaka-sayama, 589-8511, Japan
Saitama Cancer Center
Saitama, 362-0806, Japan
Hokkaido University Hospital
Sapporo, 060-8648, Japan
SHOWA Medical University Hospital
Shinagawa-ku, 142-8666, Japan
Keio University Hospital
Shinjuku-ku, 160-8582, Japan
The University of Osaka Hospital
Suita-shi, 565-0871, Japan
Shizuoka Cancer Center
Sunto-gun, 411-8777, Japan
Kanagawa Cancer Center
Yokohama, 241-8515, Japan
Erasmus MC
Rotterdam, 3015 GD, Netherlands
Zanamed Medical Clinic Sp z o o
Lublin, 20-362, Poland
Mazowiecki Szpital Wojewódzki
Siedlce, 08-110, Poland
Memorial Healthcare International S R L
Bucharest, 13823, Romania
S.C Radiotherapy Center Cluj S.R.L
Comuna Floresti, 407280, Romania
Centrul de Oncologie Sfantul Nectarie Craiova
Craiova, 200542, Romania
S.C. Sigmedical Services SRL
Suceava, 720284, Romania
Kyungpook National University Chilgok Hospital
Daegu, 700-721, South Korea
National Cancer Center
Goyang-sisouth, 10408, South Korea
Chonnam National University Hwasun Hospital
Hwasun-gun, 58128, South Korea
Gachon University Gil Medical Center
Incheon, 21565, South Korea
Seoul National University Bundang Hospital
Seongnam-si, 13620, South Korea
Severance Hospital, Yonsei University Health System
Seoul, 3722, South Korea
Asan Medical Center
Seoul, 5505, South Korea
Samsung Medical Center
Seoul, 6351, South Korea
The Catholic University of Korea, Seoul St. Marys Hospital
Seoul, 6591, South Korea
Korea University Guro Hospital
Seoul, 8308, South Korea
Hospital Universitario de Burgos
Burgos, 9006, Spain
Hospital General Universitario de Elche
Elche, 3203, Spain
Hospital Univ Regional de Málaga Hosp Civil
Málaga, 29010, Spain
Complejo Hospitalario Universitario de Orense
Ourense, 32005, Spain
Hospital Universitario de Navarra
Pamplona, 31008, Spain
Hospital Universitario Virgen Macarena
Seville, 41009, Spain
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, 833, Taiwan
China Medical University Hospital
Taichung, 40447, Taiwan
National Cheng Kung University Hospital
Tainan, 70403, Taiwan
National Taiwan University Hospital
Taipei, 100225, Taiwan
Taipei Veterans General Hospital
Taipei, 11217, Taiwan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 10, 2024
First Posted
October 16, 2024
Study Start
March 27, 2025
Primary Completion (Estimated)
June 1, 2028
Study Completion (Estimated)
November 1, 2029
Last Updated
January 12, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- Completed studies that has reached a global end or completion with all data set collected and analyzed, and for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.
- Access Criteria
- Formal request from qualified scientific and medical researchers on IPD and clinical study documents on completed clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.
De-identified individual participant data (IPD) on completed studies and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/