NCT07405151Recruiting
A Clinical Trial of Ifinatamab Deruxtecan in People With Advanced Esophageal Cancer (MK-3475-06F)
Summary
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.
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
Contacts
The trial team's contact details are shown on request.
See the official trial record- Status
- Recruiting
- Phase
- Phase 1 · Phase 2
- Study type
- Interventional
- Countries
- Switzerland, United States, Brazil, Chile, China, Czechia, Japan, Norway, South Korea, Taiwan, Thailand
- Sponsor
- Merck Sharp & Dohme LLC(Industry)
- Protocol no.
- 3475-06F
- Conditions
- Oesophageal Squamous Cell Carcinoma
- Interventions
- Biological, Drug
Treatments studied
- I-DXd
- Rescue Medication
Collaborators
Daiichi Sankyo
Locations · 32
- Chur, SwitzerlandKantonsspital Graubünden-Medizin ( Site 3700)Recruiting at this site
- Geneva, SwitzerlandHopitaux Universitaires de Geneve HUG ( Site 3701)Recruiting at this site
- Pittsburgh, United StatesUPMC Hillman Cancer Center ( Site 3904)Recruiting at this site
- Natal, BrazilLiga Norte Riograndense Contra o Cancer ( Site 3301)Recruiting at this site
- Porto Alegre, BrazilHospital Nossa Senhora Da Conceicao ( Site 3300)Recruiting at this site
- Santiago, ChileFundación Arturo López Pérez ( Site 3400)Recruiting at this site
- Santiago, ChileBradfordhill ( Site 3401)Recruiting at this site
- Hefei, ChinaAnhui Provincial Hospital ( Site 2506)Recruiting at this site
- Beijing, ChinaBeijing Cancer Hospital ( Site 2500)Recruiting at this site
- Xiamen, ChinaThe First Affiliated hospital of Xiamen University ( Site 2504)Recruiting at this site
- Zhengzhou, ChinaHenan Cancer Hospital ( Site 2501)Recruiting at this site
- Xuzhou, ChinaXuzhou Central Hospital ( Site 2502)Recruiting at this site
- Jinan, ChinaJinan Central Hospital ( Site 2507)Recruiting at this site
- Hangzhou, ChinaZhejiang Cancer Hospital ( Site 2511)Recruiting at this site
- Brno, CzechiaMasarykuv onkologicky ustav ( Site 4000)Recruiting at this site
- Nagoya, JapanAichi Cancer Center ( Site 2702)Recruiting at this site
- Yokohama, JapanKanagawa Cancer Center ( Site 2701)Recruiting at this site
- Chūō, JapanNational Cancer Center Hospital ( Site 2700)Recruiting at this site
- Oslo, NorwayOslo universitetssykehus, Radiumhospitalet ( Site 3501)Recruiting at this site
- Goyang-si, South KoreaNational Cancer Center ( Site 2902)Recruiting at this site
- Seoul, South KoreaAsan Medical Center ( Site 2901)Recruiting at this site
- Seoul, South KoreaSamsung Medical Center ( Site 2900)Recruiting at this site
- Kaohsiung City, TaiwanChang Gung Memorial Hospital at Kaohsiung ( Site 3003)Recruiting at this site
- Taichung, TaiwanChina Medical University Hospital ( Site 3007)Recruiting at this site
- Tainan, TaiwanNational Cheng Kung University Hospital ( Site 3001)Recruiting at this site
- Taipei, TaiwanNational Taiwan University Hospital ( Site 3000)Recruiting at this site
- Taipei, TaiwanNational Taiwan University Cancer Center (NTUCC) ( Site 3010)Recruiting at this site
- Taipei, TaiwanTaipei Veterans General Hospital ( Site 3005)Recruiting at this site
- Taoyuan, TaiwanChang Gung Memorial Hospital - Linkou Branch ( Site 3006)Recruiting at this site
- Bangkoknoi, ThailandFaculty of Medicine Siriraj Hospital ( Site 3102)Recruiting at this site
In total, worldwide, all 32 sites listed in the registry are recruiting.
Site status per the ClinicalTrials.gov registry (last update posted: October 2, 2026).
This status may have changed and says nothing about your eligibility: before taking any step, check with your oncologist or the site.
+ 2 more locations
Other identifiers
- 2026-525213-31-00 · other registry
- U1111-1329-6558 · other identifier
- MK-3475-06F · other identifier
- jRCT2041250179 · other registry
See also
Other versions
These results are indicative and do not replace medical advice — discuss them with your doctor.