Zolbetuximab With mFOLFOX6 or CAPOX in Claudin 18.2 Overexpressed Advanced or Metastatic Biliary … (NCT07723534) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Zolbetuximab With mFOLFOX6 or CAPOX in Claudin 18.2 Overexpressed Advanced or Metastatic Biliary Tract Cancers
United States32 participantsStarted 2026-08
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Age ≥ 18 years at the time of informed consent.
. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1 at the time of registration.
. Histological or cytological confirmation of biliary tract carcinoma per American Joint Committee on Cancer (AJCC) staging manual v8.
. Expression of Claudin 18.2 (CLDN18.2) in ≥ 75% of tumor cells demonstrating moderate to strong membranous staining as determined by central immunohistochemical testing (IHC) from a CLIA certified lab using the VENTANA CLDN18 (43-14A) antibody (Roche Diagnostics). NOTE: A paraffin block or at least 5 unstained glass "positively charged" slides with 4-microns formalin-fixed, paraffin-embedded tissue are required for testing. Tissue must be from diagnosis via standard biopsy or surgery. Specimens that are from fine-needle aspirate (FNA), cytology, or metastatic bone lesions do not qualify for CLDN18.2 staining. If archival tissue is not available and the subject is undergoing a standard of care biopsy, part of that tissue may be used for testing. If tissue for Claudin 18.2 testing is not available, the subject is not eligible for the trial.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. Receipt of only one prior line of systemic therapy for advanced disease. NOTE: Patients who received a single dose of mFOLFOX6 or CAPOX chemotherapy prior to registration may still be eligible for the trial, provided the tissue for CLDN18.2 for testing was obtained prior to the cycle of chemotherapy.
. Prior cancer treatment must be completed at least 14 days prior to start of study treatment.
Exclusion criteria
. Receipt of 5-fluorouracil or capecitabine in the adjuvant setting within 6 months prior to registration or patients who progressed on FOLFOX or CAPOX regimens in the past.
. Previous treatment with Claudin 18.2 directed treatment.
. Active infection requiring systemic therapy. NOTE: Subjects receiving prophylactic antibiotics (e.g., to prevent a urinary tract infection or chronic obstructive pulmonary disease exacerbation) are eligible for the study.
. Pregnant or breastfeeding. NOTE: breast milk cannot be stored for future use while the subject is being treated on study.
. Active central nervous system (CNS) metastases. NOTE: A subject with prior brain metastasis may be considered if they have completed their treatment for brain metastasis at least 4 weeks prior to registration, have been off corticosteroids (≤ 10 mg/day oral prednisone or equivalent) for ≥ 2 weeks, and are asymptomatic.
. Known immediate or delayed hypersensitivity, intolerance or contraindication to any component of study treatment or other monoclonal antibody.
. Known dihydropyrimidine dehydrogenase (DPD) deficiency. NOTE: Screening for DPD deficiency may be conducted per local requirements but is not required.
. Treatment with any investigational drug within 7 days prior to registration.