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

Status
Active
Cancer Type
Bile Duct Cancer
Gallbladder Cancer
Trial Phase
Phase III
Eligibility
18 Years and older, Male and Female
Study Type
Treatment
NCT ID
NCT06282575
Protocol IDs
JZP598-302 (primary)
NCI-2024-03767
2023-508219-21-00
Study Sponsor
Jazz Pharmaceuticals

Summary

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.

Eligibility

  1. Histologically- or cytologically-confirmed Biliary Tract Cancer (BTC), including Gallbladder Cancer (GBC), Intrahepatic Cholangiocarcinoma (ICC), or Extrahepatic Cholangiocarcinoma (ECC)..
  2. Locally advanced unresectable or metastatic BTC and not eligible for curative resection, transplantation, or ablative therapies.
  3. Received no more than 2 cycles of systemic therapy with gemcitabine and a platinum agent 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.
  4. 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.
  5. Assessable (measurable or non-measurable) disease as defined by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1), per investigator assessment.
  6. Male or female = 18 years or age (or the legal age of adulthood per country-specific regulations).
  7. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  8. Adequate organ function
  9. Females of childbearing potential must have a negative pregnancy test result.
  10. Females of childbearing potential and males with a partner of childbearing potential must be willing to use 2 methods of birth control.

Treatment Sites in Georgia

Winship Cancer Institute of Emory University


1365 Clifton Road NE
Building C
Atlanta, GA 30322
winshipcancer.emory.edu

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.