Zolbetuximab With mFOLFOX6 or CAPOX in Claudin 18.2 Overexpressed Advanced or Metastatic Biliary Tract Cancers
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMidhun Malla
About 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.
Eligibility criteria
Qualifiers
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.
Radiologically confirmed locally advanced/unresectable (per treating investigator) or metastatic disease.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Zolbetuximab
- mFOLFOX6
- CAPOX
Treatment groups
32 Participants
are divided into 1 treatment groupSponsors and collaborators
Midhun Malla
Lead sponsor
Hoosier Cancer Research Network
Sponsor institution
University of Alabama at Birmingham
Collaborator
Astellas Pharma Inc
Collaborator
University of Michigan
Collaborator
Source ClinicalTrials.gov