Midhun Malla
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.
Inclusion Criteria: 1. Age ≥ 18 years at the time of informed consent. 2. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1 at the time of registration. 3. Histological or cytological confirmation of biliary tract carcinoma per American Joint Committee on Cancer (AJCC) staging manual v8. 4. Radiologically confirmed locally advanced/unresectable (per treating investigator) or metastatic disease. 5. Evaluable disease per RECIST 1.1. 6. Expression of Claudin 18.2 (CLDN18.2) in ≥ 75% of tumor cells demonstrating moderate to strong membranous staining as determined by central imm…
Zolbetuximab (800 mg/m\^2) will be administered with CAPOX or mFOLFOX6 for Cycle 1. When administered with CAPOX, for every subsequent cycle Zolbetuximab (600 mg/m\^2) will be administered. When administered with mFOLFOX6, for every subsequent cycle Zolbetuximab (400 mg/m\^2).
Oxaliplatin (85 mg/m\^2), Leucovorin (400 mg/m\^2), and 5-FU (5-fluorouracil) continuous infusion (2400 mg/m\^2) will be administered every 2 weeks.
Oxaliplatin (130 mg/m\^2) and Capecitabine (750-800 mg/m\^2) will be administered every 3 weeks.
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