RecruitingPhase 3NCT06644781

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)

Sponsor

Daiichi Sankyo

Enrollment

510 participants

Start Date

Mar 27, 2025

Study Type

INTERVENTIONAL

Conditions

Esophageal Squamous Cell Carcinoma

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).

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study (IDeate-Esophageal01) is testing ifinatamab deruxtecan, a targeted antibody-drug combination, compared to standard chemotherapy in patients with advanced esophageal squamous cell carcinoma (a type of esophageal cancer) that has progressed after prior treatment. **You may be eligible if...** - You are 18 years or older - You have advanced or metastatic esophageal squamous cell carcinoma confirmed by biopsy - Your cancer has progressed after treatment with platinum-based chemotherapy and an immunotherapy checkpoint inhibitor (maximum of 1 prior treatment line) - You have at least one measurable tumor on imaging - You are in good physical health (ECOG score 0 or 1) - You are able to provide a tumor tissue sample **You may NOT be eligible if...** - You have previously received a B7-H3–targeted therapy or a topoisomerase inhibitor - Your cancer is the adenosquamous subtype - Your tumor is located near major blood vessels and poses a high bleeding risk - You have active brain metastases - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGIfinatamab deruxtecan

Intravenous administration

DRUGDocetaxel

Intravenous administration

DRUGPaclitaxel

Intravenous administration

DRUGIrinotecan hydrochloride (HCl)

Intravenous administration

Locations(88)

Providence Medical Foundation

Fullerton, California, United States

Henry Ford Health System

Detroit, Michigan, 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

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

Sainte Catherine Institut du cancer Avignon en Provence

Avignon, France

CHU Brest - Hôpital de la Cavale Blanche

Brest, France

Institut Régional du Cancer de Montpellier

Montpellier, France

Hôpital Européen Georges Pompidou

Paris, France

CHU Poitiers - Hôpital la Milétrie

Poitiers, France

Unité de recherche clinique ICANS

Strasbourg, France

CHU Toulouse Rangueil Service dOncologie médicale

Toulouse, France

Krankenhaus Nordwest GmbH

Frankfurt am Main, Germany

Hämatologisch Onkologische Praxis Eppendorf HOPE

Hamburg, 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

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

Erasmus MC

Rotterdam, Netherlands

Zanamed Medical Clinic Sp z o o

Lublin, Poland

Mazowiecki Szpital Wojewódzki

Siedlce, Poland

Memorial Healthcare International S R L

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-sisouth, 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

Hospital Univ Regional de Málaga Hosp Civil

Málaga, Spain

Complejo Hospitalario Universitario de Orense

Ourense, Spain

Hospital Universitario de Navarra

Pamplona, Spain

Hospital Universitario Virgen Macarena

Seville, Spain

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

View Full Details on ClinicalTrials.gov

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NCT06644781

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