A Single Arm Phase II Trial of Zolbetuximab in Combination With mFOLFOX6 or CAPOX Chemotherapy in Claudin 18.2 Overexpressed Advanced or Metastatic Biliary Tract Cancers
Midhun Malla
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Age ≥ 18 years at the time of informed consent. 2. ECOG Performance Status of 0-1 at the time of registration. 3. Histological or cytological confirmation of biliary tract carcinoma per 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 immunohistochemical testing (IHC) from a CLIA certified lab using the VENTANA…
Interventions
- DrugZolbetuximab
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).
- DrugmFOLFOX6
Oxaliplatin (85 mg/m\^2), Leucovorin (400 mg/m\^2), and 5-FU continuous infusion (2400 mg/m\^2) will be administered every 2 weeks.
- DrugCAPOX
Oxaliplatin (130 mg/m\^2) and Capecitabine (750-800 mg/m\^2) will be administered every 3 weeks.
Location
- University of Alabama at BirminghamBirmingham, Alabama