Zanidatamab with Standard-of-Care for HER2-Positive Biliary Tract Cancer

This study is looking at a new treatment approach for advanced HER2-positive biliary tract cancer, which includes gallbladder cancer and cholangiocarcinoma. Researchers are testing the safety and effectiveness of Zanidatamab, given with standard chemotherapy (Cisplatin and Gemcitabine), and potentially with an additional drug like Durvalumab or Pembrolizumab. This combination aims to be a first-line treatment. To join, you must have HER2-positive biliary tract cancer that is advanced or has spread and cannot be removed by surgery. The main goal is to see how long people live without their cancer getting worse (Progression Free Survival). The study plans to enroll 286 participants, but its current status is unclear.

Study design
This study is an interventional trial planning to enroll 286 participants. It is evaluating different drug combinations for advanced HER2-positive biliary tract cancer.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The study will measure Progression Free Survival for up to 52 months.

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

NCT06282575

Efficacy and Safety of Zanidatamab With Standard-of-care Therapy Against Standard-of-care Therapy for Advanced HER2-positive Biliary Tract Cancer

Recruiting
PHASE3Ages 18+InterventionalTreatment
Jazz Pharmaceuticals
~286 participants
Updated 2026-07-14 on ClinicalTrials.gov
What's tested:ZanidatamabCisplatinGemcitabinePembrolizumabDurvalumab

At a glance

Recruiting sites
156 of 185 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Progression Free Survival (PFS) in participants with Immunohistochemistry (IHC) 3+ tumors
Measured over Up to 52 months
Biliary Tract Cancer
185 sites across 99 states
Spain11
Italy9
France8
South Korea8
Santiago Metropolitan5
Israel5
Portugal5
Taiwan5
Clinical Trial Disclosure & Transparency
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  • Progression Free Survival (PFS) in participants with Immunohistochemistry (IHC) 3+ tumorsUp to 52 months

    PFS is defined as the time from the date of randomization to the date of documented disease progression, or death from any cause.