Clinical Trial

Zolbetuximab With mFOLFOX6 or CAPOX in Claudin 18.2 Overexpressed Advanced or Metastatic Biliary Tract Cancers

Not Yet Recruiting Phase 2
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Summary
Subjects will receive zolbetuximab with either CAPOX every 3 weeks or mFOLFOX6 every 2 weeks. The chemotherapy regimen chosen, mFOLFOX6 or CAPOX is per the treating investigator discretion and subject preference. Study treatment will continue for a maximum of 2 years, or until disease progression per RECIST 1.1, intolerable side effects, or investigator/subject preference. Disease evaluation will occur every 8 to 9 weeks.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2026-07-20.
Trial Details
NCT Number NCT07723534
Lead Sponsor Midhun Malla
Collaborators: University of Alabama at Birmingham, Astellas Pharma Inc, University of Michigan
Conditions Advanced Biliary Tract Cancer, Metastatic Biliary Tract Carcinoma
Enrollment 32 participants
Start Date 2026-08
Primary Completion 2029-02 (estimated)
Study Completion 2030-08 (estimated)
Updated on ClinicalTrials.gov 2026-07-24