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A Study of Ifinatamab Deruxtecan in Subjects With Pretreated Advanced or Metastatic Esophageal Squamous Cell Carcinoma (ESCC) (IDeate-Esophageal01)
Sponsor: Daiichi Sankyo
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).
Official 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)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
510
Start Date
2025-03-27
Completion Date
2029-11-01
Last Updated
2026-10-26
Healthy Volunteers
No
Conditions
Interventions
Ifinatamab deruxtecan
Intravenous administration
Docetaxel
Intravenous administration
Paclitaxel
Intravenous administration
Irinotecan hydrochloride (HCl)
Intravenous administration
Locations (168)
Mayo Clinic Hospital
Phoenix, Arizona, United States
Providence Medical Foundation
Fullerton, California, United States
USC Norris Comprehensive Cancer Center
Los Angeles, California, United States
Univ of California Irvine College of Medicine
Orange, California, United States
Henry Ford Health System
Detroit, Michigan, United States
Mayo Clinic Rochester
Rochester, Minnesota, United States
MidAmerica Cancer Care - American Oncology Partners
Kansas City, Missouri, United States
Morristown Medical Center
Morristown, New Jersey, United States
Maimonides Cancer Center
Brooklyn, New York, United States
Penn State University Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States
Baptist Cancer Center
Memphis, Tennessee, United States
SCRI Oncology Partners
Nashville, Tennessee, United States
John Peter Smith Hospital
Fort Worth, Texas, United States
Virginia Cancer Specialists
Fairfax, Virginia, United States
Institut Jules Bordet
Brussels, Belgium
Cliniques Universitaires Saint-Luc
Brussels, Belgium
Antwerp University Hospital
Edegem, Belgium
Universitair Ziekenhuis Gent
Ghent, Belgium
UZ Leuven
Leuven, Belgium
Chu de Liege
Liège, Belgium
Anyang Cancer Hospital
Anyang, China
Beijing Cancer Hospital
Beijing, China
Jilin Cancer Hospital
Changchun, China
The First Hospital of Jilin University
Changchun, China
Changzhou Cancer Hospital
Changzhou, China
Sichuan cancer hospital
Chengdu, China
West China Hospital Sichuan University
Chengdu, China
Fujian Cancer Hospital
Fuzhou, China
The First Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, China
Zhejiang Cancer Hospital
Hangzhou, China
Harbin Medical University Cancer Hospital
Harbin, China
Anhui Provincial Cancer Hospital
Hefei, China
The First Affiliated Hospital of Fujian Medical University
Hefei, China
The Second Hospital of Anhui Medical University
Hefei, China
Jieyang Peoples Hospital
Jieyang, China
Jinan Central Hospital
Jinan, China
Shandong Cancer Hospital
Jinan, China
Affiliated Hospital of Jining Medical University
Jining, China
Linyi Cancer Hospital
Linyi, China
The First Affiliated Hospital of Henan University of Science and Technology
Luoyang, China
Guangxi Medical University Affiliated Tumor Hospital
Nanning, China
Cancer Hospital of Shantou University Medical College
Shantou, China
Liaoning Cancer Hospital and Institute
Shenyang, China
Tianjin Medical University Cancer Institute and Hospital
Tianjin, China
The First Affiliated Hospital of Xinxiang Medical University
Weihui, China
Hubei Cancer Hospital
Wuhan, China
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, China
Zhongshan Hospital Xiamen University
Xiamen, China
Subei Peoples Hospital
Yangzhou, China
Henan Cancer Hospital
Zhengzhou, China
Aarhus University Hospital
Arhus N, Denmark
Rigshospitalet
Copenhagen, Denmark
Odense University Hospital. Department of Research, Oncology
Odense C, Denmark
Sainte Catherine Institut du cancer Avignon en Provence
Avignon, France
CHU Brest - Hôpital de la Cavale Blanche
Brest, France
Centre Georges François Leclerc
Dijon, France
Hopital Claude Huriez - Chu Lille
Lille, France
Centre Leon Berard
Lyon, France
Institut Paoli Calmettes
Marseille, France
Institut Régional du Cancer de Montpellier
Montpellier, France
Chru De Nantes Hotel-Dieu
Nantes, France
Centre Antoine Lacassagne
Nice, France
Hôpital Européen Georges Pompidou
Paris, France
Hăpital Saint-Antoine
Paris, France
Chu Bordeaux - Hăpital Haut-Lăvăque
Pessac, France
CHU Poitiers - Hôpital la Milétrie
Poitiers, France
Crlcc Eugene Marquis
Rennes, France
Institut Curie - Centre Renă Huguenin
Saint-Cloud, France
Institut de Cancărologie de Strasbourg Europe - Icans
Strasbourg, France
CHU Toulouse Rangueil Service dOncologie médicale
Toulouse, France
Charité - Campus Charité Mitte
Berlin, Germany
Vivantes Klinikum Im Friedrichshain
Berlin, Germany
Universitaetsklinikum Bonn Aoer
Bonn, Germany
Universitaetsklinikum Carl Gustav Carus TU Dresden
Dresden, Germany
Krankenhaus Nordwest GmbH
Frankfurt am Main, Germany
Hämatologisch Onkologische Praxis Eppendorf HOPE
Hamburg, Germany
Asklepios Klinik Altona
Hamburg, Germany
Universitaetsklinikum Jena
Jena, Germany
Universitaetsklinikum Leipzig AoeR
Leipzig, Germany
Klinikum Nuernberg Nord
Nuremberg, Germany
Universitaetsklinikum Tuebingen
Tübingen, Germany
Clinica Oncologica-AOU delle Marche second floor
Ancona, Italy
National Institute of Gastroenterology Saverio De Bellis Research Hospital
Castellana Grotte, Italy
IRCCS Ospedale Policlinico San Martino
Genova, Italy
IRCCS Ospedale San Raffaele
Milan, Italy
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, Italy
Azienda Ospedaliera Universitaria Luigi Vanvitelli
Naples, Italy
IOV - Istituto Oncologico Veneto IRCCS
Padova, Italy
Azienda Ospedaliero Universitaria Pisana
Pisa, Italy
Fondazione Policlinico Gemelli
Rome, Italy
IRCCS Istituto Clinico Humanitas
Rozzano, Italy
A.O. Pia Fondazione Cardinale G. Panico
Tricase, Italy
National Cancer Center Hospital
Chūōku, Japan
Hiroshima University Hospital
Hiroshima, Japan
National Cancer Center Hospital East
Kashiwa, Japan
Kagawa University Hospital
Kita-gun, Japan
Kobe City Hospital Organization Kobe City Medical Center General Hospital
Kobe, Japan
Cancer Institute Hospital of JFCR
Kōtoku, Japan
Nho Shikoku Cancer Center
Matsuyama, Japan
Aichi Cancer Center
Nagoya, Japan