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Clinical Trials in China / NCT07405151
Recruiting Phase 1/2

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

NCT07405151 · tracked via the Priya Life Science China tracker
Sponsor
Merck Sharp & Dohme LLC
Phase
Phase 1/2
Started
2026-03-27
Last updated
2026-09-17

Condition(s) studied

Oesophageal Squamous Cell Carcinoma

Investigational drug(s) / intervention(s)

I-DXd →Rescue Medication

I-DXd: IV Infusion

Rescue Medication: Includes 5-HT3 receptor antagonist, NK-1 receptor antagonist, and corticosteroid, administered per approved product label

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (32)

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

More Merck Sharp & Dohme LLC trials in China

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07405151 on ClinicalTrials.gov ↗ ← All trials in China