Tests zanidatamab with standard chemotherapy for HER2-positive bile duct cancer
Tests zanidatamab plus standard chemotherapy in adults with advanced HER2-positive biliary tract cancer.
Plain-language title generated from the registry record
Registry title: Efficacy and Safety of Zanidatamab With Standard-of-care Therapy Against Standard-of-care Therapy for Advanced HER2-positive Biliary Tract Cancer
Key facts
- Where
- Bundang-Gu, Seongnam-Si, Busan, Ilsandong-gu, Goyang-si, Seongnam-si, and Seoul, South KoreaSee the 11 sites
- Phase
- Phase 3
Where in South Korea
- CHA Bundang Medical Center, CHA UniversityBundang-Gu, Seongnam-Si, South KoreaNo longer taking part
- Pusan National University HospitalBusan, South KoreaNo longer taking part
- National Cancer CenterIlsandong-gu, Goyang-si, South KoreaNo longer taking part
- Seoul National University Bundang HospitalSeongnam-si, South KoreaNo longer taking part
- Asan Medical CenterSeoul, South KoreaTaking people
- Samsung Medical CenterSeoul, South KoreaTaking people
- Hanyang University Seoul HospitalSeoul, South KoreaNo longer taking part
- Korea University Anam HospitalSeoul, South KoreaNo longer taking part
- Korea University Guro HospitalSeoul, South KoreaNo longer taking part
- Seoul National University HospitalSeoul, South KoreaNo longer taking part
- Severance Hospital, Yonsei University Health SystemSeoul, South KoreaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Jazz Pharmaceuticals
- Trial code
- NCT06282575EU 2023-508219-21-00
- Record updated
- 28 October 2026
- Original 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.Read full original descriptionShow less
An Open-label Randomized Trial of the Efficacy and Safety of Zanidatamab With Standard-of-care Therapy Against Standard-of-care Therapy Alone for Advanced HER2-positive Biliary Tract Cancer
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.
Inclusion: 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: Prior treatment with a HER2-targeted agent; Prior treatment with checkpoint inhibitors, other than durvalumab or pembrolizumab; Use of systemic corticosteroids; Active or prior autoimmune inflammatory conditions; 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; Severe chronic or active infections; History of allogeneic organ transplantation; History of interstitial lung disease or non-infectious pneumonitis; Brain metastases; 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.