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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

2026-01-12

Healthy Volunteers

Conditions

Esophageal Squamous Cell Carcinoma

Interventions

DRUG

Ifinatamab deruxtecan

Intravenous administration

DRUG

Docetaxel

Intravenous administration

DRUG

Paclitaxel

Intravenous administration

DRUG

Irinotecan hydrochloride (HCl)

Intravenous administration

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.

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

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (88)