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Recruiting Phase 3

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

NCT06644781 · tracked via the Priya Life Science UK tracker
Phase
Phase 3
Started
2025-03-27
Last updated
2026-10-26

Condition(s) studied

Esophageal Squamous Cell Carcinoma

Investigational drug(s) / intervention(s)

Ifinatamab deruxtecan →Docetaxel →Paclitaxel →Irinotecan hydrochloride (HCl) →

Ifinatamab deruxtecan: Intravenous administration

Docetaxel: Intravenous administration

Paclitaxel: Intravenous administration

Irinotecan hydrochloride (HCl): Intravenous administration

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Overall Survival (OS) — From the date of randomization to the date of death due to any cause, up to approximately 54 months
    Overall Survival (OS) is defined as the time interval from the date of randomization to the date of death due to any cause.

Trial sites (168)

FacilityCityRegionStatus
Mayo Clinic Hospital Phoenix Arizona Recruiting
Providence Medical Foundation Fullerton California Recruiting
USC Norris Comprehensive Cancer Center Los Angeles California Recruiting
Univ of California Irvine College of Medicine Orange California Recruiting
Henry Ford Health System Detroit Michigan Recruiting
Mayo Clinic Rochester Rochester Minnesota Recruiting
MidAmerica Cancer Care - American Oncology Partners Kansas City Missouri Recruiting
Morristown Medical Center Morristown New Jersey Recruiting
Maimonides Cancer Center Brooklyn New York Recruiting
Penn State University Milton S. Hershey Medical Center Hershey Pennsylvania Recruiting
Baptist Cancer Center Memphis Tennessee Recruiting
SCRI Oncology Partners Nashville Tennessee Recruiting
John Peter Smith Hospital Fort Worth Texas Recruiting
Virginia Cancer Specialists Fairfax Virginia Recruiting
Institut Jules Bordet Brussels Belgium Recruiting
Cliniques Universitaires Saint-Luc Brussels Belgium Recruiting
Antwerp University Hospital Edegem Belgium Recruiting
Universitair Ziekenhuis Gent Ghent Belgium Recruiting
UZ Leuven Leuven Belgium Recruiting
Chu de Liege Liège Belgium Recruiting
Anyang Cancer Hospital Anyang China Recruiting
Beijing Cancer Hospital Beijing China Recruiting
Jilin Cancer Hospital Changchun China Recruiting
The First Hospital of Jilin University Changchun China Recruiting
Changzhou Cancer Hospital Changzhou China Recruiting
Sichuan cancer hospital Chengdu China Recruiting
West China Hospital Sichuan University Chengdu China Recruiting
Fujian Cancer Hospital Fuzhou China Recruiting
The First Affiliated Hospital Zhejiang University School of Medicine Hangzhou China Recruiting
Zhejiang Cancer Hospital Hangzhou China Recruiting
Harbin Medical University Cancer Hospital Harbin China Recruiting
Anhui Provincial Cancer Hospital Hefei China Recruiting
The First Affiliated Hospital of Fujian Medical University Hefei China Recruiting
The Second Hospital of Anhui Medical University Hefei China Recruiting
Jieyang Peoples Hospital Jieyang China Recruiting
Jinan Central Hospital Jinan China Recruiting
Shandong Cancer Hospital Jinan China Recruiting
Affiliated Hospital of Jining Medical University Jining China Recruiting
Linyi Cancer Hospital Linyi China Recruiting
The First Affiliated Hospital of Henan University of Science and Technology Luoyang China Recruiting

+ 128 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06644781 on ClinicalTrials.gov ↗ ← All trials in the UK