A Study of Ifinatamab Deruxtecan for Advanced Esophageal Cancer

This study is testing a treatment called ifinatamab deruxtecan (I-DXd) for people with advanced esophageal squamous cell carcinoma (ESCC). I-DXd is an antibody-drug conjugate (ADC), which means it's designed to find cancer cells and deliver medicine directly to them. To join, you must have ESCC that has spread or can't be removed by surgery, and your cancer must have progressed after 1 or 2 previous treatments. The main goal is to see how many participants experience their cancer shrinking or disappearing after receiving I-DXd. This study plans to enroll 60 participants, but its current status is unclear.

Study design
This is an interventional study with a planned enrollment of 60 participants. The phase of the study is not specified.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint, Objective Response Rate, is measured for up to approximately 14 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07405151

A Clinical Trial of Ifinatamab Deruxtecan in People With Advanced Esophageal Cancer (MK-3475-06F)

Recruiting
PHASE1Ages 18+InterventionalTreatment
Merck Sharp & Dohme LLC
~60 participants
Updated 2026-09-17 on ClinicalTrials.gov
What's tested:I-DXdRescue Medication

At a glance

Recruiting sites
32 of 32 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Objective Response Rate (ORR)
Measured over Up to approximately 14 months
Oesophageal Squamous Cell Carcinoma

NCT07405151

Where you'd take part

This study runs at 32 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Aichi Cancer Center ( Site 2702)

    Nagoya, Aichi-ken, Japanstudy coordinator listed

    Recruiting

  • Anhui Provincial Hospital ( Site 2506)

    Hefei, Anhui, Chinastudy coordinator listed

    Recruiting

  • Asan Medical Center ( Site 2901)

    Seoul, South Koreastudy coordinator listed

    Recruiting

  • Beijing Cancer Hospital ( Site 2500)

    Beijing, Beijing Municipality, Chinastudy coordinator listed

    Recruiting

  • Bradfordhill ( Site 3401)

    Santiago, Region M. de Santiago, Chilestudy coordinator listed

    Recruiting

  • Chang Gung Memorial Hospital - Linkou Branch ( Site 3006)

    Taoyuan, Taiwanstudy coordinator listed

    Recruiting

  • Chang Gung Memorial Hospital at Kaohsiung ( Site 3003)

    Kaohsiung City, Taiwanstudy coordinator listed

    Recruiting

  • China Medical University Hospital ( Site 3007)

    Taichung, Taiwanstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

  • Medical Director · STUDY_DIRECTOR · Merck Sharp & Dohme LLC

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Eligibility criteria

Inclusion

Has a histologically or cytologically confirmed diagnosis of unresectable locally advanced or metastatic esophageal squamous cell carcinoma (ESCC)
Has disease progression after 1 or 2 prior lines of systemic therapy for unresectable locally advanced or metastatic ESCC
Has measurable disease
If infected with human immunodeficiency virus (HIV), has well-controlled HIV on antiretroviral therapy
Has adequate organ function

Exclusion

Has histologically or cytologically confirmed adenocarcinoma or adenosquamous carcinoma subtype
Has uncontrollable pleural effusion, pericardial effusion, or ascites requiring frequent drainage or medical intervention
Has clinically significant corneal disease
Has any of the following within 6 months before screening: cerebrovascular accident, transient ischemic attack, other arterial thromboembolic event
If infected with HIV, has a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
Has uncontrolled or significant cardiovascular disease
Has a known additional malignancy that is progressing or has required active treatment within the past 3 years
Has known active central nervous system metastases and/or carcinomatous meningitis
Has any history of interstitial lung disease (ILD)/pneumonitis irrespective of steroid use, except for a history of radiation pneumonitis that did not require steroids or has current diagnosis of ILD or has clinical or radiographic suspicion of ILD for which the diagnosis of ILD cannot be ruled out
Has active infection requiring systemic therapy other than those permitted.
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 enrollment, severe asthma, severe chronic obstructive pulmonary disease, 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
  • Objective Response Rate (ORR)Up to approximately 14 months

    ORR is defined as the percentage of participants with Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1). The percentage of participants who experience CR or PR as assessed by Blinded Independent Central Review (BICR) will be presented.