RECRUITING Phase 1 / Phase 2 ClinicalTrials.gov

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

Sponsor: Merck Sharp & Dohme LLC • ClinicalTrials.gov ID: NCT07405151

Registry updated: 2026-10-02

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Description

The purpose of this trial is to assess if ifinatamab deruxtecan (I-DXd) can treat esophageal squamous cell carcinoma (ESCC). I-DXd is an antibody-drug conjugate (ADC). An ADC attaches to a protein on cancer cells and delivers treatment to destroy those cells. The goal of this trial is to learn how many participants who receive I-DXd have the cancer respond, which means the cancer gets smaller or goes away.

Interventions

I-DXd (Biological)
IV Infusion
Rescue Medication (Drug)
Includes 5-HT3 receptor antagonist, NK-1 receptor antagonist, and corticosteroid, administered per approved product label

Eligibility criteria

Inclusion Criteria: * 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 Criteria: * 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

Conditions

Oesophageal Squamous Cell Carcinoma

Locations

UPMC Hillman Cancer Center ( Site 3904) — Pittsburgh, Pennsylvania, United States
Liga Norte Riograndense Contra o Cancer ( Site 3301) — Natal, Rio Grande do Norte, Brazil
Hospital Nossa Senhora Da Conceicao ( Site 3300) — Porto Alegre, Rio Grande do Sul, Brazil
Fundación Arturo López Pérez ( Site 3400) — Santiago, Region M. de Santiago, Chile
Bradfordhill ( Site 3401) — Santiago, Region M. de Santiago, Chile
Anhui Provincial Hospital ( Site 2506) — Hefei, Anhui, China
Beijing Cancer Hospital ( Site 2500) — Beijing, Beijing Municipality, China
The First Affiliated hospital of Xiamen University ( Site 2504) — Xiamen, Fujian, China
Henan Cancer Hospital ( Site 2501) — Zhengzhou, Henan, China
Xuzhou Central Hospital ( Site 2502) — Xuzhou, Jiangsu, China
Jinan Central Hospital ( Site 2507) — Jinan, Shandong, China
Zhejiang Cancer Hospital ( Site 2511) — Hangzhou, Zhejiang, China
Masarykuv onkologicky ustav ( Site 4000) — Brno, Brno-mesto, Czechia
Aichi Cancer Center ( Site 2702) — Nagoya, Aichi-ken, Japan
Kanagawa Cancer Center ( Site 2701) — Yokohama, Kanagawa, Japan
National Cancer Center Hospital ( Site 2700) — Chūō, Tokyo, Japan
Oslo universitetssykehus, Radiumhospitalet ( Site 3501) — Oslo, Norway
National Cancer Center ( Site 2902) — Goyang-si, Kyonggi-do, South Korea
Asan Medical Center ( Site 2901) — Seoul, South Korea
Samsung Medical Center ( Site 2900) — Seoul, South Korea
Kantonsspital Graubünden-Medizin ( Site 3700) — Chur, Kanton Graubünden, Switzerland
Hopitaux Universitaires de Geneve HUG ( Site 3701) — Geneva, Switzerland
Chang Gung Memorial Hospital at Kaohsiung ( Site 3003) — Kaohsiung City, Taiwan
China Medical University Hospital ( Site 3007) — Taichung, Taiwan
National Cheng Kung University Hospital ( Site 3001) — Tainan, Taiwan
National Taiwan University Hospital ( Site 3000) — Taipei, Taiwan
National Taiwan University Cancer Center (NTUCC) ( Site 3010) — Taipei, Taiwan
Taipei Veterans General Hospital ( Site 3005) — Taipei, Taiwan
Chang Gung Memorial Hospital - Linkou Branch ( Site 3006) — Taoyuan, Taiwan
Faculty of Medicine Siriraj Hospital ( Site 3102) — Bangkoknoi, Bangkok, Thailand
Chulalongkorn University ( Site 3104) — Pathumwan, Bangkok, Thailand
Songklanagarind Hospital ( Site 3101) — Hat Yai, Changwat Songkhla, Thailand

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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