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Zolbetuximab with Chemotherapy for Advanced Biliary Tract Cancers

This study is testing a new treatment for advanced or metastatic biliary tract cancer. It combines a drug called zolbetuximab with standard chemotherapy, either mFOLFOX6 or CAPOX. Doctors will decide which chemotherapy you receive, also considering your preference. The main goal is to see how long people live without their cancer growing (progression-free survival) at 6 months. You might be able to join if you are 18 or older, have a good performance status (meaning you can do most daily activities), and have a confirmed diagnosis of biliary tract cancer. The study aims to enroll 32 participants.

Study design
This is an interventional study with an unclear status, planning to enroll 32 participants. It is not specified if it is randomized or blinded.
What's involved
You would receive zolbetuximab with either CAPOX every 3 weeks or mFOLFOX6 every 2 weeks. Treatment can continue for up to 2 years, or until your disease progresses or side effects become too much. Your disease will be checked every 8 to 9 weeks.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint measures progression-free survival at 6 months, but the duration of follow-up after treatment is not specified.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07723534

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

Not Yet Recruiting
PHASE2Ages 18+InterventionalTreatment
Midhun Malla
~32 participants
Updated 2026-07-24 on ClinicalTrials.gov
What's tested:ZolbetuximabmFOLFOX6CAPOX

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Progression free survival (PFS) rate
Measured over 6 months

Conditions

Advanced Biliary Tract Cancer
Metastatic Biliary Tract Carcinoma

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Biliary Tract Carcinoma

NCT07723534

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • University of Alabama at Birmingham

    Birmingham, Alabamano site contact published

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Midhun Malla, MD, MS · PRINCIPAL_INVESTIGATOR · University of Alabama at Birmingham
  • Vaibhav Sahai, MBBS, MS · PRINCIPAL_INVESTIGATOR · University of Michigan

Who to contact

Midhun Malla, MD, MS
[email protected]
205-996-9740
Email the study team

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Eligibility criteria

Inclusion

Hematological
Platelets (Plt) ≥ 100,000 /mm3
Absolute Neutrophil Count (ANC) ≥ 1500 K/mm3
Hemoglobin (Hgb) ≥ 9 g/dL
Renal
Calculated creatinine clearance ≥ 50 mL/min (Cockcroft-Gault formula will be used to calculate creatinine clearance)
Hepatic
Total bilirubin ≤ 2 g/dl
Aspartate aminotransferase (AST) ≤ 2.5 × ULN without liver metastases and ≤ 5x ULN if liver metastases are present
Alanine aminotransferase (ALT) ≤ 2.5 × ULN without liver metastases and ≤ 5x ULN if liver metastases are present
Coagulation
International Normalized Ratio (INR) or Prothrombin Time (PT) Activated Partial Thromboplastin Time (aPTT) ≤ 1.5 × ULN except for subjects receiving anticoagulation therapy.
Other
Albumin ≥ 2.5 g/dL

Exclusion

Congestive heart failure (defined as New York Heart Association \[NYHA\] Class III or IV), myocardial infarction, unstable angina, coronary angioplasty, coronary stenting, coronary artery bypass graft, cerebrovascular accident (CVA), or hypertensive crisis within 6 months prior to registration
History of clinically significant ventricular arrhythmias (i.e., sustained ventricular tachycardia, ventricular fibrillation, or Torsades de Pointes)
History or family history of congenital long QT syndrome
Cardiac arrhythmias requiring anti-arrhythmic medications (Subjects with rate controlled atrial fibrillation for \> 28 days prior to registration are eligible.) 11. Major surgical procedure ≤ 28 days prior to registration. 12. Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimen. 13. Known psychiatric illness or social situations such as incarceration that would preclude study compliance, per investigator judgment.

What this trial measures

  • Progression free survival (PFS) rate6 months

    PFS will be defined as the percentage of evaluable patients alive and progression-free (radiologically per RECIST 1.1 or clinically per treating investigator discretion) at 6 months from date of registration.