NCT06282575 · Jazz Pharmaceuticals
Efficacy and Safety of Zanidatamab With Standard-of-care Therapy Against Standard-of-care Therapy for Advanced HER2-positive Biliary Tract Cancer
What this study is about
The purpose of this study is to evaluate the effectiveness 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.
View original scientific description
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.
Interventions
DRUG
Zanidatamab
Administered intravenously (IV)
DRUG
Cisplatin
Administered intravenously (IV)
DRUG
Gemcitabine
Administered intravenously (IV)
DRUG
Pembrolizumab
Administered intravenously (IV)
DRUG
Durvalumab
Administered intravenously (IV)
Primary outcome measures
Progression Free Survival (PFS) in participants with Immunohistochemistry (IHC) 3+ tumors
Time frame: Up 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Histologically- or cytologically-confirmed Biliary Tract Cancer (BTC), including Gallbladder Cancer (GBC), Intrahepatic Cholangiocarcinoma (ICC), or Extrahepatic Cholangiocarcinoma (ECC).
- Locally advanced unresectable or metastatic BTC and not eligible for curative resection, transplantation, or ablative therapies.
- Received no more than 2 cycles of systemic therapy which is limited to Cisplatin and Gemcitabine (CisGem) with or without a PD-1/L1 inhibitor (physician's choice of durvalumab or pembrolizumab, where approved under local regulations) for advanced unresectable or metastatic disease.
- HER2-positive disease (defined as IHC 3+; or IHC 2+/ ISH+) by IHC and in situ Hybridization (ISH) assay (in participants with IHC 2+ tumors) at a central laboratory on new biopsy tissue or archival tissue from the most recent biopsy.
- Assessable (measurable or non-measurable) disease as defined by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1), per investigator assessment.
- Male or female ≥ 18 years or age (or the legal age of adulthood per country-specific regulations).
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Adequate organ function
- Females of childbearing potential must have a negative pregnancy test result.
- Females of childbearing potential and males with a partner of childbearing potential must be willing to use 2 methods of birth control.
Exclusion criteria
- Prior treatment with a HER2-targeted agent
- Prior treatment with checkpoint inhibitors, other than durvalumab or pembrolizumab
- The following BTC histologic subtypes are excluded: small cell cancer, neuroendocrine tumors, lymphoma, sarcoma, mixed tumor histology, and mucinous cystic neoplasms detected in the biliary tract region.
- Use of systemic corticosteroids.
- Brain metastases
- Severe chronic or active infections
- History of allogeneic organ transplantation.
- Active or prior autoimmune inflammatory conditions
- History of interstitial lung disease or non-infectious pneumonitis.
- Participation in another clinical trial with an investigational medicinal product within the last 3 months.
- Females who are breastfeeding
- Any other medical, social, or psychosocial factors that, in the opinion of the investigator, could impact safety or compliance with study procedures.
- Use of phenytoin
Where
- Duarte, California
- Lone Tree, Colorado
- Orlando, Florida
- Atlanta, Georgia
- Westwood, Kansas
- Louisville, Kentucky
- New Orleans, Louisiana
- Boston, Massachusetts
- Ann Arbor, Michigan
- Detroit, Michigan
- Maple Grove, Minnesota
- Morristown, New Jersey
And 7 more locations — see the full list below.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Sep 14, 2026 · Source of record for eligibility and locations