A Study of Ifinatamab Deruxtecan in Subjects With Pretreated Advanced or Metastatic Esophageal Squamous Cell Carcinoma (ESCC) (IDeate-Esophageal01)
NCT ID: NCT06644781
Last Updated: 2026-01-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE3
510 participants
INTERVENTIONAL
2025-03-27
2029-11-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Ivonescimab Plus Short-Course Hypofractionated Radiotherapy as Second-Line Therapy for Esophageal Squamous Cell Carcinoma
NCT07188103
Irinotecan Plus S1 Versus S1 in Patients With Previously Treated Advanced Esophageal Cancer: ESWN 01 Trial
NCT02319187
Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of IPM514 in Patients with Esophageal Squamous Cell Carcinoma
NCT06690476
SI-B001 Combined With Irinotecan in the Treatment of Recurrent Metastatic Esophageal Squamous Cell Carcinoma.
NCT05022654
Neoadjuvant Ivonescimab and Chemotherapy in Resectable Esophageal Cancer
NCT06814158
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
The key secondary objectives of the study will evaluate the progression-free survival (PFS) and objective response rate (ORR) benefit of I-DXd compared with ICC.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
I-DXd
Participants who are randomized to receive an intravenous infusion of I-DXd 12 mg/kg on Day 1 of every 21-day cycle (Q3W).
Ifinatamab deruxtecan
Intravenous administration
Investigator's Choice of Chemotherapy (ICC)
Participants who are randomized to receive an intravenous infusion of investigator's choice of chemotherapy (docetaxel, paclitaxel, and irinotecan HCl).
Docetaxel
Intravenous administration
Paclitaxel
Intravenous administration
Irinotecan hydrochloride (HCl)
Intravenous administration
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Ifinatamab deruxtecan
Intravenous administration
Docetaxel
Intravenous administration
Paclitaxel
Intravenous administration
Irinotecan hydrochloride (HCl)
Intravenous administration
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Merck Sharp & Dohme LLC
INDUSTRY
Daiichi Sankyo
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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
Napoli, , Italy
IOV - Istituto Oncologico Veneto IRCCS
Padua, , 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
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2023-509630-19-00
Identifier Type: CTIS
Identifier Source: secondary_id
DS7300-202
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.