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

Recruiting now · Phase 1/Phase 2

Conditions studied: Oesophageal Squamous Cell Carcinoma

In brief

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.

Key facts

Study ID

NCT07405151

Run by

Merck Sharp & Dohme LLC

People needed

60

Starts

2026-03-27

Expected to finish

2028-06-12

Last updated by the study team

2026-07-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• UPMC Hillman Cancer Center ( Site 3904) — Pittsburgh, Pennsylvania, United States (enrolling)
• Liga Norte Riograndense Contra o Cancer ( Site 3301) — Natal, Rio Grande do Norte, Brazil (enrolling)
• Beijing Cancer Hospital ( Site 2500) — Beijing, Beijing Municipality, China (enrolling)
• Jinan Central Hospital ( Site 2507) — Jinan, Shandong, China (enrolling)
• Masarykuv onkologicky ustav ( Site 4000) — Brno, Brno-mesto, Czechia (enrolling)
• Aichi Cancer Center ( Site 2702) — Nagoya, Aichi-ken, Japan (enrolling)
• Kanagawa Cancer Center ( Site 2701) — Yokohama, Kanagawa, Japan (enrolling)
• National Cancer Center Hospital ( Site 2700) — Chūō, Tokyo, Japan (enrolling)
• Oslo universitetssykehus, Radiumhospitalet ( Site 3501) — Oslo, Norway (enrolling)
• National Cancer Center ( Site 2902) — Goyang-si, Kyonggi-do, South Korea (enrolling)
• Asan Medical Center ( Site 2901) — Seoul, South Korea (enrolling)
• Samsung Medical Center ( Site 2900) — Seoul, South Korea (enrolling)
• Kantonsspital Graubünden-Medizin ( Site 3700) — Chur, Kanton Graubünden, Switzerland (enrolling)
• Hopitaux Universitaires de Geneve HUG ( Site 3701) — Geneva, Switzerland (enrolling)
• Chang Gung Memorial Hospital at Kaohsiung ( Site 3003) — Kaohsiung City, Taiwan (enrolling)
• China Medical University Hospital ( Site 3007) — Taichung, Taiwan (enrolling)
• National Cheng Kung University Hospital ( Site 3001) — Tainan, Taiwan (enrolling)
• National Taiwan University Hospital ( Site 3000) — Taipei, Taiwan (enrolling)
• National Taiwan University Cancer Center (NTUCC) ( Site 3010) — Taipei, Taiwan (enrolling)
• Taipei Veterans General Hospital ( Site 3005) — Taipei, Taiwan (enrolling)
• Chang Gung Memorial Hospital - Linkou Branch ( Site 3006) — Taoyuan, Taiwan (enrolling)
• Faculty of Medicine Siriraj Hospital ( Site 3102) — Bangkoknoi, Bangkok, Thailand (enrolling)
• Songklanagarind Hospital ( Site 3101) — Hat Yai, Changwat Songkhla, Thailand (enrolling)

Full record on ClinicalTrials.gov

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