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New hope for tough esophageal cancer: experimental drug takes on chemo in major trial

NCT ID NCT06644781

Disease control Sponsor: Daiichi Sankyo Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 05, 2026 · Updated 2 times

Summary

This study tests a new drug called ifinatamab deruxtecan (I-DXd) in people with advanced esophageal cancer that has worsened after standard treatments like platinum chemotherapy and immunotherapy. About 510 adults will be randomly assigned to receive either I-DXd or a standard chemotherapy chosen by their doctor. The main goal is to see if I-DXd helps people live longer.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 510 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2025

Expected to finish

Nov 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: Participants must meet all of the following criteria to be eligible for randomization into the study: 1. Participants aged ≥18 years (follow local regulatory requirements if the legal age of consent for study participation is \>18 years old). 2. Has histologically or cytologically documented unresectable locally advanced or metastatic ESCC according to American Joint Committee on Cancer 8th edition staging system on ESCC. 3. 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. 4. The participant must provide adequate baseline tumor samples with sufficient quantity and quality of tumor tissue content as defined in the Laboratory Manual. 5. 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. 6. Has an ECOG PS of 0 or 1 within 7 days prior to Cycle 1 Day 1. Exclusion Criteria: Participants who meet any of the following criteria will be disqualified from entering the study: 1. Has received prior treatment with orlotamab, enoblituzumab, or other B7-H3 targeted agents, including I-DXd. 2. Has received any topoisomerase inhibitor. 3. Has histologically or cytologically confirmed adenosquamous carcinoma subtype. 4. Is ineligible to all the chemotherapies in the comparator arm due to prior progression or intolerance. 5. 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. 6. 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. 7. Has any of the following within the past 6 months: cerebrovascular accident, transient ischemic attack, other arterial thromboembolic event, or pulmonary embolism. 8. Has a clinically significant corneal disease. 9. 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. 10. 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. 11. 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.

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Conditions

The condition(s) this trial relates to.

esophageal squamous cell carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Esophageal squamous cell carcinoma

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    132 sites in 17 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Aarhus University Hospital

    RECRUITING

    Arhus N, 8200, Denmark

  • Affiliated Hospital of Jining Medical University

    RECRUITING

    Jining, 272029, China

  • Aichi Cancer Center

    RECRUITING

    Nagoya, 464-8681, Japan

  • Akershus Universitetssykehus Hf

    RECRUITING

    Lørenskog, 1478, Norway

  • Altnagelvin Area Hospital

    RECRUITING

    Belfast, BT47 1SB, United Kingdom

  • Amsterdam UMC - location VUmc

    RECRUITING

    Amsterdam, 1105 AZ, Netherlands

  • Antwerp University Hospital

    RECRUITING

    Edegem, 2650, Belgium

  • Anyang Cancer Hospital

    RECRUITING

    Anyang, 455000, China

  • Asan Medical Center

    RECRUITING

    Seoul, 5505, South Korea

  • Asklepios Klinik Altona

    RECRUITING

    Hamburg, 22763, Germany

  • Azienda Ospedaliera Universitaria Luigi Vanvitelli

    RECRUITING

    Naples, 80131, Italy

  • Baptist Cancer Center

    RECRUITING

    Memphis, Tennessee, 38120, United States

  • Barts Hospital

    RECRUITING

    London, EC1A 7BE, United Kingdom

  • Beijing Cancer Hospital

    RECRUITING

    Beijing, 100142, China

  • CHU Brest - Hôpital de la Cavale Blanche

    RECRUITING

    Brest, 29609, France

  • CHU Poitiers - Hôpital la Milétrie

    RECRUITING

    Poitiers, 86000, France

  • CHU Toulouse Rangueil Service dOncologie médicale

    RECRUITING

    Toulouse, 31059, France

  • Cancer Institute Hospital of JFCR

    RECRUITING

    Kōtoku, 135-8550, Japan

  • Centre Georges François Leclerc

    RECRUITING

    Dijon, 21079, France

  • Centrul de Oncologie Sfantul Nectarie Craiova

    RECRUITING

    Craiova, 200542, Romania

  • Changzhou Cancer Hospital

    RECRUITING

    Changzhou, 213001, China

  • Charing Cross Hospital

    RECRUITING

    London, W2 1NY, United Kingdom

  • Charité - Campus Charité Mitte

    RECRUITING

    Berlin, 10117, Germany

  • China Medical University Hospital

    NOT_YET_RECRUITING

    Taichung, 40447, Taiwan

  • Chonnam National University Hwasun Hospital

    RECRUITING

    Hwasun-gun, 58128, South Korea

  • Chu de Liege

    RECRUITING

    Liège, 4000, Belgium

  • Cliniques Universitaires Saint-Luc

    RECRUITING

    Brussels, 1200, Belgium

  • Complejo Hospitalario Universitario de Orense

    RECRUITING

    Ourense, 32005, Spain

  • Crlcc Eugene Marquis

    RECRUITING

    Rennes, 35042, France

  • Derriford Hospital

    RECRUITING

    Plymouth, PL6 8DH, United Kingdom

  • Erasmus MC

    RECRUITING

    Rotterdam, 3015 GD, Netherlands

  • Fondazione IRCCS Istituto Nazionale dei Tumori

    RECRUITING

    Milan, 20133, Italy

  • Fondazione Policlinico Gemelli

    RECRUITING

    Rome, 00168, Italy

  • Fujian Cancer Hospital

    RECRUITING

    Fuzhou, 350015, China

  • Gachon University Gil Medical Center

    RECRUITING

    Incheon, 21565, South Korea

  • Guangxi Medical University Affiliated Tumor Hospital

    RECRUITING

    Nanning, 530021, China

  • Harbin Medical University Cancer Hospital

    RECRUITING

    Harbin, 150081, China

  • Henry Ford Health System

    RECRUITING

    Detroit, Michigan, 48202, United States

  • Hiroshima University Hospital

    RECRUITING

    Hiroshima, 734-8551, Japan

  • Hokkaido University Hospital

    RECRUITING

    Sapporo, 060-8648, Japan

  • Hospital General Universitario Gregorio Marañon

    RECRUITING

    Madrid, 28007, Spain

  • Hospital General Universitario de Elche

    RECRUITING

    Elche, 3203, Spain

  • Hospital Univ Regional de Málaga Hosp Civil

    RECRUITING

    Málaga, 29010, Spain

  • Hospital Universitari i Politecnic La Fé

    RECRUITING

    Valencia, 46026, Spain

  • Hospital Universitario Central de Asturias

    RECRUITING

    Oviedo, 33013, Spain

  • Hospital Universitario Marques de Valdecilla

    RECRUITING

    Santander, 39012, Spain

  • Hospital Universitario Virgen Macarena

    RECRUITING

    Seville, 41009, Spain

  • Hospital Universitario de Burgos

    RECRUITING

    Burgos, 9006, Spain

  • Hospital Universitario de Navarra

    RECRUITING

    Pamplona, 31008, Spain

  • Hubei Cancer Hospital

    RECRUITING

    Wuhan, 430000, China

  • Hämatologisch Onkologische Praxis Eppendorf HOPE

    RECRUITING

    Hamburg, 20249, Germany

  • Hôpital Européen Georges Pompidou

    RECRUITING

    Paris, 75015, France

  • IOV - Istituto Oncologico Veneto IRCCS

    RECRUITING

    Padova, 35128, Italy

  • IRCCS Istituto Clinico Humanitas

    RECRUITING

    Rozzano, 20089, Italy

  • Ico L Hospitalet - Hospital Duran I Reynals

    RECRUITING

    L'Hospitalet de Llobregat, 08908, Spain

  • Institut Jules Bordet

    RECRUITING

    Brussels, 1070, Belgium

  • Institut Régional du Cancer de Montpellier

    RECRUITING

    Montpellier, 34298, France

  • Institutul Clinic Fundeni

    RECRUITING

    Bucharest, 22328, Romania

  • Jilin Cancer Hospital

    RECRUITING

    Changchun, 130000, China

  • Jinan Central Hospital

    RECRUITING

    Jinan, 250013, China

  • John Peter Smith Hospital

    RECRUITING

    Fort Worth, Texas, 76104, United States

  • Kagawa University Hospital

    RECRUITING

    Kita-gun, 761-0793, Japan

  • Kanagawa Cancer Center

    RECRUITING

    Yokohama, 241-8515, Japan

  • Kaohsiung Chang Gung Memorial Hospital

    RECRUITING

    Kaohsiung City, 833, Taiwan

  • Karolinska Universitetssjukhuset Solna

    RECRUITING

    Solna, 17164, Sweden

  • Keio University Hospital

    RECRUITING

    Shinjuku-ku, 160-8582, Japan

  • Kindai University Hospital

    RECRUITING

    Ōsaka-sayama, 589-8511, Japan

  • Klinikum Nuernberg Nord

    RECRUITING

    Nuremberg, 90419, Germany

  • Kobe City Hospital Organization Kobe City Medical Center General Hospital

    RECRUITING

    Kobe, 650-0047, Japan

  • Korea University Guro Hospital

    RECRUITING

    Seoul, 8308, South Korea

  • Krankenhaus Nordwest GmbH

    RECRUITING

    Frankfurt am Main, 60488, Germany

  • Kyungpook National University Chilgok Hospital

    RECRUITING

    Daegu, 700-721, South Korea

  • Liaoning Cancer Hospital and Institute

    RECRUITING

    Shenyang, 110042, China

  • Maimonides Cancer Center

    RECRUITING

    Brooklyn, New York, 11220, United States

  • Mayo Clinic Hospital

    RECRUITING

    Phoenix, Arizona, 85054, United States

  • Mayo Clinic Rochester

    RECRUITING

    Rochester, Minnesota, 55905, United States

  • Mazowiecki Szpital Wojewódzki

    RECRUITING

    Siedlce, 08-110, Poland

  • Memorial Healthcare International S R L

    RECRUITING

    Bucharest, 13823, Romania

  • MidAmerica Cancer Care - American Oncology Partners

    RECRUITING

    Kansas City, Missouri, 64132, United States

  • Morristown Medical Center

    RECRUITING

    Morristown, New Jersey, 07960, United States

  • National Cancer Center

    RECRUITING

    Goyang-si, 10408, South Korea

  • National Cancer Center Hospital

    RECRUITING

    Chūōku, 104-0045, Japan

  • National Cancer Center Hospital East

    RECRUITING

    Kashiwa, 277-8577, Japan

  • National Cheng Kung University Hospital

    RECRUITING

    Tainan, 70403, Taiwan

  • National Taiwan University Hospital

    RECRUITING

    Taipei, 100225, Taiwan

  • Netherlands Cancer Institute

    RECRUITING

    Amsterdam, 1066CX, Netherlands

  • Ninewells Hospital

    RECRUITING

    Dundee, DD1 9SY, United Kingdom

  • Odense University Hospital. Department of Research, Oncology

    RECRUITING

    Odense C, 5000, Denmark

  • Osaka International Cancer Institute

    RECRUITING

    Osaka, 541-8567, Japan

  • Penn State University Milton S. Hershey Medical Center

    RECRUITING

    Hershey, Pennsylvania, 17033, United States

  • Providence Medical Foundation

    RECRUITING

    Fullerton, California, 92835, United States

  • Rigshospitalet

    RECRUITING

    Copenhagen, 2100, Denmark

  • S.C Radiotherapy Center Cluj S.R.L

    RECRUITING

    Comuna Floresti, 407280, Romania

  • S.C. Sigmedical Services SRL

    RECRUITING

    Suceava, 720284, Romania

  • SCRI Oncology Partners

    RECRUITING

    Nashville, Tennessee, 37203, United States

  • SHOWA Medical University Hospital

    RECRUITING

    Shinagawa-ku, 142-8666, Japan

  • Sahlgrenska Sjukhuset

    RECRUITING

    Gothenburg, 41345, Sweden

  • Sainte Catherine Institut du cancer Avignon en Provence

    RECRUITING

    Avignon, 84918, France

  • Saitama Cancer Center

    RECRUITING

    Saitama, 362-0806, Japan

  • Samsung Medical Center

    RECRUITING

    Seoul, 6351, South Korea

  • Sarah Cannon Research Institute UK

    RECRUITING

    London, W1G 6AD, United Kingdom

  • Seoul National University Bundang Hospital

    RECRUITING

    Seongnam-si, 13620, South Korea

  • Severance Hospital, Yonsei University Health System

    RECRUITING

    Seoul, 3722, South Korea

  • Shandong Cancer Hospital

    RECRUITING

    Jinan, 250117, China

  • Shikoku Cancer Center

    RECRUITING

    Matsuyama, 791-0280, Japan

  • Shizuoka Cancer Center

    RECRUITING

    Sunto-gun, 411-8777, Japan

  • Sichuan cancer hospital

    RECRUITING

    Chengdu, 610041, China

  • Stavanger University Hospital

    RECRUITING

    Stavanger, 4011, Norway

  • Subei Peoples Hospital

    RECRUITING

    Yangzhou, 225001, China

  • Taipei Veterans General Hospital

    RECRUITING

    Taipei, 11217, Taiwan

  • The Catholic University of Korea, Seoul St. Marys Hospital

    RECRUITING

    Seoul, 6591, South Korea

  • The Christie

    RECRUITING

    Manchester, M20 4BX, United Kingdom

  • The First Affiliated Hospital of Fujian Medical University

    RECRUITING

    Hefei, 230088, China

  • The First Affiliated Hospital of Xinxiang Medical University

    RECRUITING

    Weihui, 453100, China

  • The University of Osaka Hospital

    RECRUITING

    Suita-shi, 565-0871, Japan

  • Tianjin Medical University Cancer Institute and Hospital

    RECRUITING

    Tianjin, 453000, China

  • UZ Leuven

    RECRUITING

    Leuven, 3000, Belgium

  • Union Hospital Tongji Medical College Huazhong University of Science and Technology

    RECRUITING

    Wuhan, 430022, China

  • Unité de recherche clinique ICANS

    RECRUITING

    Strasbourg, 67033, France

  • Univ of California Irvine College of Medicine

    RECRUITING

    Orange, California, 92868, United States

  • Universitaetsklinikum Bonn Aoer

    RECRUITING

    Bonn, 53127, Germany

  • Universitaetsklinikum Carl Gustav Carus TU Dresden

    RECRUITING

    Dresden, 01307, Germany

  • Universitaetsklinikum Jena

    RECRUITING

    Jena, 07743, Germany

  • Universitaetsklinikum Leipzig AoeR

    RECRUITING

    Leipzig, 04103, Germany

  • Universitaetsklinikum Tuebingen

    RECRUITING

    Tübingen, 72076, Germany

  • University College London Hospitals

    RECRUITING

    London, NW1 2BU, United Kingdom

  • Virginia Cancer Specialists

    RECRUITING

    Fairfax, Virginia, 22031, United States

  • Vivantes Klinikum Im Friedrichshain

    RECRUITING

    Berlin, 10249, Germany

  • West China Hospital Sichuan University

    RECRUITING

    Chengdu, 610041, China

  • Wojskowy Instytut Medyczny

    RECRUITING

    Warsaw, 04-141, Poland

  • Zanamed Medical Clinic Sp z o o

    RECRUITING

    Lublin, 20-362, Poland

  • Zhongshan Hospital Xiamen University

    RECRUITING

    Xiamen, 361004, China

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