A Phase 3 interventional study of Zanidatamab and Cisplatin in Biliary Tract Cancer, sponsored by Jazz Pharmaceuticals. Recruiting at 185 sites in 25 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-14.
Sponsored by Jazz Pharmaceuticals · Phase 3, Interventional, and Treatment
The purpose of this study is to evaluate the efficacy and safety of Zanidatamab plus CisGem (Cisplatin and Gemcitabine) with or without the addition of a programmed death protein 1/ligand-1 (PD-1/L1) inhibitor (physician's choice of either Durvalumab or Pembrolizumab, where approved under local regulations) as first line of treatment for participants with human epidermal growth factor receptor 2 (HER2)-positive biliary tract cancer.
Exclusion Criteria
Zanidatamab plus standard of care treatment of CisGem with or without a PD-1/L1 inhibitor. PD-1/L1 inhibitor will be physician's choice of either Durvalumab or Pembrolizumab, where approved under local regulations.
Drug: Zanidatamab · Drug: Cisplatin · Drug: Gemcitabine · Drug: Pembrolizumab · Drug: Durvalumab
Standard of care treatment of CisGem with or without a PD-1/L1 inhibitor. PD-1/L1 inhibitor will be physician's choice of either Durvalumab or Pembrolizumab, where approved under local regulations.
Drug: Cisplatin · Drug: Gemcitabine · Drug: Pembrolizumab · Drug: Durvalumab
Administered intravenously (IV)
Also known as: ZW25, JZP598, ZIIHERA®
Administered intravenously (IV)
Administered intravenously (IV)
Administered intravenously (IV)
Administered intravenously (IV)
Progression Free Survival (PFS) in participants with Immunohistochemistry (IHC) 3+ tumors
PFS is defined as the time from the date of randomization to the date of documented disease progression, or death from any cause.
Time frame: Up to 52 months
Overall survival (OS) in participants with IHC 3+ tumors
OS is defined as the time from randomization to death, due to any cause.
Time frame: Up to 68 months
Progression Free Survival for all participants
PFS is defined as the time from the date of randomization to the date of documented disease progression, or death from any cause.
Time frame: Up to 68 months
OS for all participants
OS is defined as the time from randomization to death, due to any cause.
Time frame: Up to 68 months
Number of participants achieving Confirmed objective response rate (cORR)
Confirmed objective response rate is defined as achieving a confirmed best overall response of Complete Response (CR) or Partial Response (PR)
Time frame: Up to 68 months
Duration of response (DOR)
Duration of response is defined as the time from the first objective response (CR or PR) to documented Progressive Disease (PD) or death, from any cause.
Time frame: Up to 68 months
Number of Patients reporting Treatment-Emergent Adverse Events (TEAE)
Time frame: Up to 68 months
Maximum serum concentration of Zanidatamab
Time frame: Up to 68 months
Number of participants who develop Anti-drug antibodies (ADAs) to Zanidatamab
Time frame: Up to 68 months
Time to definitive deterioration (TDD) for participants with IHC 3+ tumors in patient-reported Physical Functioning (PF) domain score as measured by the EORTC QLQ-C30
TDD is defined as the time from randomization to the first confirmed clinical meaningful deterioration or death. European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Core 30 (QLQ-C30) final scores range from 0 to 100, where higher scores reflect better functioning
Time frame: Up to 68 months
TDD for all participants in patient-reported PF domain score as measured by the EORTC QLQ-C30
TDD is defined as the time from randomization to the first confirmed clinical meaningful deterioration or death. EORTC QLQ-C30 final scores range from 0 to 100, where higher scores reflect better functioning.
Time frame: Up to 68 months
TDD for participants with IHC 3+ tumors in patient-reported symptoms scores as measured by the EORTC QLQ-BIL21 (Pain, Jaundice, Abdominal Pain and Pruritis)
TDD is defined as the time from randomization to the first confirmed clinical meaningful deterioration or death. EORTC Quality of Life Questionnaire - Cholangiocarcinoma and Gallbladder Cancer module (QLQ-BIL21) (Pain, Jaundice, Abdominal Pain, and Pruritis) final scores range from 0 to 100, where higher scores reflect better functioning.
Time frame: Up to 68 months
TDD for all participants in patient-reported symptoms scores as measured by the EORTC QLQ-BIL21 (Pain, Jaundice, Abdominal Pain, and Pruritis)
TDD is defined as the time from randomization to the first confirmed clinical meaningful deterioration or death. EORTC QLQ-BIL21 (Pain, Jaundice, Abdominal Pain, and Pruritis) final scores range from 0 to 100, where higher scores reflect better functioning.
Time frame: Up to 68 months
Showing the first 100 of 185 sites across 25 countries.
Plan to share: Yes — In accordance with ICMJE requirements, Jazz Pharmaceuticals may provide qualified external researchers access to individual participant data (IPD) and clinical trial data that underlie the results of this trial upon request. Qualified researchers can submit a request on https://www.jazzpharma.com/science/clinical-trial-data-sharing/ as outlined. Jazz Pharmaceuticals reserves the right not to consider a request. For inquiries about Jazz's data sharing policy contact clinicaldatasharing@jazzpharma.com
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