Zolbetuximab for Biliary Tract Carcinoma
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Who Is on the Research Team?
Midhun Malla, MD, MS
Principal Investigator
University of Alabama at Birmingham
Vaibhav Sahai, MBBS, MS
Principal Investigator
University of Michigan
Are You a Good Fit for This Trial?
This trial is for adults with advanced or metastatic biliary tract cancer whose tumors have high levels of Claudin 18.2. Participants must have had only one prior treatment for advanced disease, good organ function, and be in generally good health. People who are pregnant, breastfeeding, or have certain other illnesses can't join.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive zolbetuximab with either CAPOX every 3 weeks or mFOLFOX6 every 2 weeks for up to 2 years
Disease Evaluation
Disease evaluation occurs every 8 to 9 weeks to assess progression
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- CAPOX
- mFOLFOX6
- Zolbetuximab
Trial Overview
The study tests zolbetuximab (an antibody drug) combined with either mFOLFOX6 or CAPOX chemotherapy. The choice between the two chemo regimens depends on doctor and patient preference. Treatment continues up to 2 years unless the cancer worsens or side effects become too severe.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Subjects will receive zolbetuximab with CAPOX every 3 weeks or with mFOLFOX6 every 2 weeks.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Midhun Malla
Lead Sponsor
University of Michigan
Collaborator
University of Alabama at Birmingham
Collaborator
Astellas Pharma Inc
Industry Sponsor
Tadaaki Taniguchi
Astellas Pharma Inc
Chief Medical Officer since 2023
MD, PhD
Naoki Okamura
Astellas Pharma Inc
Chief Executive Officer since 2023
University of Tokyo, Faculty of Pharmacy
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