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NCT07405151RecruitingPhase 1/2

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

A Phase 2 Open-Label, Umbrella Platform Design Study of Investigational Agent(s) in Participants With 2L/3L Unresectable Locally Advanced or Metastatic Esophageal Cancer: KEYMAKER-U06 Substudy 06F

Source: ClinicalTrials.gov · Last updated 2 Oct 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Phase 1/2
Study type
Interventional
Enrollment
60 (estimated)
First submitted
5 Feb 2026
Start date
27 Mar 2026
Primary completion date
12 Jun 2027
Lead sponsor
Merck Sharp & Dohme LLC
NCT number
NCT07405151
EU CT number
2026-525213-31-00

What you commit to

  • Study type: Interventional · Phase 1/2
  • Planned participants: 60
  • From 27 Mar 2026 to the primary completion date, 12 Jun 2027
  • 32 sites in 11 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Has any of the following within 6 months before screening: cerebrovascular accident, transient ischemic attack, other arterial thromboembolic event
  • 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

Other illness

  • Has clinically significant corneal disease
  • 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 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.

Other

  • 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 known active central nervous system metastases and/or carcinomatous meningitis

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (32)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Liga Norte Riograndense Contra o Cancer ( Site 3301)
Coordinator of this site? Confirm its status
NatalBrazilRecruiting
Hospital Nossa Senhora Da Conceicao ( Site 3300)
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Porto AlegreBrazilRecruiting
Kantonsspital Graubünden-Medizin ( Site 3700)
Coordinator of this site? Confirm its status
ChurSwitzerlandRecruiting
Hopitaux Universitaires de Geneve HUG ( Site 3701)
Coordinator of this site? Confirm its status
GenevaSwitzerlandRecruiting
Fundación Arturo López Pérez ( Site 3400)
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SantiagoChileRecruiting
Bradfordhill ( Site 3401)
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SantiagoChileRecruiting
Beijing Cancer Hospital ( Site 2500)
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BeijingChinaRecruiting
Zhejiang Cancer Hospital ( Site 2511)
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HangzhouChinaRecruiting
Anhui Provincial Hospital ( Site 2506)
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HefeiChinaRecruiting
Jinan Central Hospital ( Site 2507)
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JinanChinaRecruiting
The First Affiliated hospital of Xiamen University ( Site 2504)
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XiamenChinaRecruiting
Xuzhou Central Hospital ( Site 2502)
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XuzhouChinaRecruiting
Henan Cancer Hospital ( Site 2501)
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ZhengzhouChinaRecruiting
Masarykuv onkologicky ustav ( Site 4000)
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BrnoCzechiaRecruiting
National Cancer Center Hospital ( Site 2700)
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ChūōJapanRecruiting
Aichi Cancer Center ( Site 2702)
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NagoyaJapanRecruiting
Kanagawa Cancer Center ( Site 2701)
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YokohamaJapanRecruiting
National Cancer Center ( Site 2902)
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Goyang-siSouth KoreaRecruiting
Samsung Medical Center ( Site 2900)
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SeoulSouth KoreaRecruiting
Asan Medical Center ( Site 2901)
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SeoulSouth KoreaRecruiting
Oslo universitetssykehus, Radiumhospitalet ( Site 3501)
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OsloNorwayRecruiting
Faculty of Medicine Siriraj Hospital ( Site 3102)
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BangkoknoiThailandRecruiting
Songklanagarind Hospital ( Site 3101)
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Hat YaiThailandRecruiting
Chulalongkorn University ( Site 3104)
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PathumwanThailandRecruiting
Chang Gung Memorial Hospital at Kaohsiung ( Site 3003)
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Kaohsiung CityTaiwanRecruiting
China Medical University Hospital ( Site 3007)
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TaichungTaiwanRecruiting
National Cheng Kung University Hospital ( Site 3001)
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TainanTaiwanRecruiting
Taipei Veterans General Hospital ( Site 3005)
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TaipeiTaiwanRecruiting
National Taiwan University Hospital ( Site 3000)
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TaipeiTaiwanRecruiting
National Taiwan University Cancer Center (NTUCC) ( Site 3010)
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TaipeiTaiwanRecruiting
Chang Gung Memorial Hospital - Linkou Branch ( Site 3006)
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TaoyuanTaiwanRecruiting
UPMC Hillman Cancer Center ( Site 3904)
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PittsburghUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.