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RECRUITING
NCT06644781
PHASE3

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

Sponsor: Daiichi Sankyo

View on ClinicalTrials.gov

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

2026-08-04

Healthy Volunteers

No

Interventions

DRUG

Ifinatamab deruxtecan

Intravenous administration

DRUG

Docetaxel

Intravenous administration

DRUG

Paclitaxel

Intravenous administration

DRUG

Irinotecan hydrochloride (HCl)

Intravenous administration

Locations (132)

Mayo Clinic Hospital

Phoenix, Arizona, United States

Providence Medical Foundation

Fullerton, 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

UZ Leuven

Leuven, Belgium

Chu de Liege

Liège, Belgium

Anyang Cancer Hospital

Anyang, China

Beijing Cancer Hospital

Beijing, China

Jilin Cancer Hospital

Changchun, China

Changzhou Cancer Hospital

Changzhou, China

Sichuan cancer hospital

Chengdu, China

West China Hospital Sichuan University

Chengdu, China

Fujian Cancer Hospital

Fuzhou, China

Harbin Medical University Cancer Hospital

Harbin, China

The First Affiliated Hospital of Fujian Medical University

Hefei, China

Jinan Central Hospital

Jinan, China

Shandong Cancer Hospital

Jinan, China

Affiliated Hospital of Jining Medical University

Jining, China

Guangxi Medical University Affiliated Tumor Hospital

Nanning, 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

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

Institut Régional du Cancer de Montpellier

Montpellier, France

Hôpital Européen Georges Pompidou

Paris, France

CHU Poitiers - Hôpital la Milétrie

Poitiers, France

Crlcc Eugene Marquis

Rennes, France

Unité de recherche clinique 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

Fondazione IRCCS Istituto Nazionale dei Tumori

Milan, Italy

Azienda Ospedaliera Universitaria Luigi Vanvitelli

Naples, Italy

IOV - Istituto Oncologico Veneto IRCCS

Padova, Italy

Fondazione Policlinico Gemelli

Rome, Italy

IRCCS Istituto Clinico Humanitas

Rozzano, 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

Shikoku Cancer Center

Matsuyama, Japan

Aichi Cancer Center

Nagoya, Japan

Osaka International Cancer Institute

Osaka, Japan

Kindai University Hospital

Ōsaka-sayama, Japan

Saitama Cancer Center

Saitama, Japan

Hokkaido University Hospital

Sapporo, Japan

SHOWA Medical University Hospital

Shinagawa-ku, Japan

Keio University Hospital

Shinjuku-ku, Japan

The University of Osaka Hospital

Suita-shi, Japan

Shizuoka Cancer Center

Sunto-gun, Japan

Kanagawa Cancer Center

Yokohama, Japan

Netherlands Cancer Institute

Amsterdam, Netherlands

Amsterdam UMC - location VUmc

Amsterdam, Netherlands

Erasmus MC

Rotterdam, Netherlands

Akershus Universitetssykehus Hf

Lørenskog, Norway

Stavanger University Hospital

Stavanger, Norway

Zanamed Medical Clinic Sp z o o

Lublin, Poland

Mazowiecki Szpital Wojewódzki

Siedlce, Poland

Wojskowy Instytut Medyczny

Warsaw, Poland

Memorial Healthcare International S R L

Bucharest, Romania

Institutul Clinic Fundeni

Bucharest, Romania

S.C Radiotherapy Center Cluj S.R.L

Comuna Floresti, Romania

Centrul de Oncologie Sfantul Nectarie Craiova

Craiova, Romania

S.C. Sigmedical Services SRL

Suceava, Romania

Kyungpook National University Chilgok Hospital

Daegu, South Korea

National Cancer Center

Goyang-si, South Korea

Chonnam National University Hwasun Hospital

Hwasun-gun, South Korea

Gachon University Gil Medical Center

Incheon, South Korea

Seoul National University Bundang Hospital

Seongnam-si, South Korea

Severance Hospital, Yonsei University Health System

Seoul, South Korea

Asan Medical Center

Seoul, South Korea

Samsung Medical Center

Seoul, South Korea

The Catholic University of Korea, Seoul St. Marys Hospital

Seoul, South Korea

Korea University Guro Hospital

Seoul, South Korea

Hospital Universitario de Burgos

Burgos, Spain

Hospital General Universitario de Elche

Elche, Spain

Ico L Hospitalet - Hospital Duran I Reynals

L'Hospitalet de Llobregat, Spain

Hospital General Universitario Gregorio Marañon

Madrid, Spain

Hospital Univ Regional de Málaga Hosp Civil

Málaga, Spain

Complejo Hospitalario Universitario de Orense

Ourense, Spain

Hospital Universitario Central de Asturias

Oviedo, Spain

Hospital Universitario de Navarra

Pamplona, Spain

Hospital Universitario Marques de Valdecilla

Santander, Spain

Hospital Universitario Virgen Macarena

Seville, Spain

Hospital Universitari i Politecnic La Fé

Valencia, Spain

Sahlgrenska Sjukhuset

Gothenburg, Sweden

Karolinska Universitetssjukhuset Solna

Solna, Sweden

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, Taiwan

China Medical University Hospital

Taichung, Taiwan

National Cheng Kung University Hospital

Tainan, Taiwan

National Taiwan University Hospital

Taipei, Taiwan

Taipei Veterans General Hospital

Taipei, Taiwan

Altnagelvin Area Hospital

Belfast, United Kingdom

Ninewells Hospital

Dundee, United Kingdom

Barts Hospital

London, United Kingdom

University College London Hospitals

London, United Kingdom

Sarah Cannon Research Institute UK

London, United Kingdom

Charing Cross Hospital

London, United Kingdom

The Christie

Manchester, United Kingdom

Derriford Hospital

Plymouth, United Kingdom