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

Exclusion Criteria

• •3. 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.
• •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.
• •1. Prior treatment with a HER2-targeted agent
• •2. Prior treatment with checkpoint inhibitors, other than durvalumab or pembrolizumab
• •3. 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.
• •4. Use of systemic corticosteroids.
• •5. Brain metastases
• •6. Severe chronic or active infections
• •7. History of allogeneic organ transplantation.
• •8. Active or prior autoimmune inflammatory conditions
• •9. History of interstitial lung disease or non-infectious pneumonitis.
• •10. Participation in another clinical trial with an investigational medicinal product within the last 3 months.
• •11. Females who are breastfeeding
• •12. Any other medical, social, or psychosocial factors that, in the opinion of the investigator, could impact safety or compliance with study procedures.
• •13. Use of phenytoin