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

NCT07723534 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2026-07-24

No results posted yet for this study

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.

Conditions

  • Advanced Biliary Tract Cancer
  • Metastatic Biliary Tract Carcinoma

Interventions

DRUG

Zolbetuximab

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).

DRUG

mFOLFOX6

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.

DRUG

CAPOX

Oxaliplatin (130 mg/m\^2) and Capecitabine (750-800 mg/m\^2) will be administered every 3 weeks.

Sponsors & Collaborators

  • University of Alabama at Birmingham

    collaborator OTHER

  • Astellas Pharma Inc

    collaborator INDUSTRY

  • University of Michigan

    collaborator OTHER

  • Midhun Malla

    lead OTHER

Principal Investigators

  • Midhun Malla, MD, MS · University of Alabama at Birmingham

  • Vaibhav Sahai, MBBS, MS · University of Michigan

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-31
Primary Completion
2029-02-28
Completion
2030-08-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07723534 on ClinicalTrials.gov