Zolbetuximab With mFOLFOX6 or CAPOX in Claudin 18.2 Overexpressed Advanced or Metastatic Biliary Tract Cancers

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Midhun Malla
Study ID
NCT07723534
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Advanced Biliary Tract Cancer
  • Metastatic Biliary Tract Carcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Zolbetuximab — DRUG
    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).
  • mFOLFOX6 — DRUG
    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.
  • CAPOX — DRUG
    Oxaliplatin (130 mg/m\^2) and Capecitabine (750-800 mg/m\^2) will be administered every 3 weeks.

Study Details

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.

Key Dates

First listed
Jul 23, 2026
Start date
Aug 31, 2026
Status verified
Jul 2026
Primary completion
Feb 28, 2029
Completion
Aug 31, 2030

Study Design

Enrollment
32 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Zolbetuximab and CAPOX or mFOLFOX6
    Subjects will receive zolbetuximab with CAPOX every 3 weeks or with mFOLFOX6 every 2 weeks.

Primary Outcome Measure

Progression free survival (PFS) rate [ Time Frame: 6 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Alabama at BirminghamBirminghamAlabama35233-

Find similar trials in Birmingham, AL

By research site
University of Alabama at Birmingham· Birmingham, AL

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