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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

Status: Recruiting
Location: See all (17) locations...
Intervention Type: Biological, Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
China
Beijing Cancer Hospital ( Site 2500)
RECRUITING
Beijing
Japan
National Cancer Center Hospital ( Site 2700)
RECRUITING
Chūō
Aichi Cancer Center ( Site 2702)
RECRUITING
Nagoya
Kanagawa Cancer Center ( Site 2701)
RECRUITING
Yokohama
Norway
Oslo universitetssykehus, Radiumhospitalet ( Site 3501)
RECRUITING
Oslo
Republic of Korea
National Cancer Center ( Site 2902)
RECRUITING
Goyang-si
Asan Medical Center ( Site 2901)
RECRUITING
Seoul
Samsung Medical Center ( Site 2900)
RECRUITING
Seoul
Switzerland
Kantonsspital Graubünden-Medizin ( Site 3700)
RECRUITING
Chur
Hopitaux Universitaires de Geneve HUG ( Site 3701)
RECRUITING
Geneva
Taiwan
Chang Gung Memorial Hospital at Kaohsiung ( Site 3003)
RECRUITING
Kaohsiung City
China Medical University Hospital ( Site 3007)
RECRUITING
Taichung
National Cheng Kung University Hospital ( Site 3001)
RECRUITING
Tainan
National Taiwan University Cancer Center (NTUCC) ( Site 3010)
RECRUITING
Taipei
National Taiwan University Hospital ( Site 3000)
RECRUITING
Taipei
Taipei Veterans General Hospital ( Site 3005)
RECRUITING
Taipei
Chang Gung Memorial Hospital - Linkou Branch ( Site 3006)
RECRUITING
Taoyuan
Contact Information
Primary
Toll Free Number
Trialsites@msd.com
1-888-577-8839
Time Frame
Start Date: 2026-03-27
Estimated Completion Date: 2028-06-12
Participants
Target number of participants: 60
Treatments
Experimental: I-DXd
Participants will be administered I-DXd every 3 weeks until progressive disease or discontinuation criteria are met.
Related Therapeutic Areas
Sponsors
Collaborators: Daiichi Sankyo
Leads: Merck Sharp & Dohme LLC

This content was sourced from clinicaltrials.gov

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