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
- Bunkyō-Ku, Chiba, Chuo Ku, Fukuoka, Kagoshima, Kanazawa, Kashiwa, Koto-ku, Kyoto, Matsuyama, Mitaka-shi, Nagoya, Niigata, Osaka, Sapporo, Sendai, Suita-shi, Tsu, Ube-shi, and Yokohama, JapanSee the 20 sites
- Phase
- Phase 3
Where in Japan
- The University of Tokyo HospitalBunkyō-Ku, JapanTaking people
- Chiba Cancer CenterChiba, JapanTaking people
- National Cancer Center HospitalChuo Ku, JapanNo longer taking part
- National Hospital Organization Kyushu Cancer CenterFukuoka, JapanNo longer taking part
- Kagoshima University HospitalKagoshima, JapanNo longer taking part
- Kanazawa University HospitalKanazawa, JapanTaking people
- National Cancer Center Hospital EastKashiwa, JapanTaking people
- The Cancer Institute Hospital of Japanese Foundation for Cancer ResearchKoto-ku, JapanTaking people
- Kyoto University HospitalKyoto, JapanTaking people
- National Hospital Organization Shikoku Cancer CenterMatsuyama, JapanNo longer taking part
- Kyorin University HospitalMitaka-shi, JapanTaking people
- Aichi Cancer CenterNagoya, JapanNo longer taking part
- Niigata University Medical and Dental HospitalNiigata, JapanTaking people
- Osaka Prefectural Hospital Organization - Osaka International Cancer InstituteOsaka, JapanTaking people
- Hokkaido University HospitalSapporo, JapanTaking people
- Tohoku University HospitalSendai, JapanNo longer taking part
- Osaka University HospitalSuita-shi, JapanTaking people
- Mie University HospitalTsu, JapanNo longer taking part
- Yamaguchi University HospitalUbe-shi, JapanNo longer taking part
- Kanagawa Cancer CenterYokohama, JapanNo 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.