Expanded Access Treatment with Zanidatamab for Patients with HER2-Positive Advanced Biliary Tract Cancer

Inclusion Criteria

• Have advanced biliary tract cancer that is HER2-positive and has worsened after trying other treatments.
• Have a heart that pumps blood well, with a function of 50% or more.
• Have organs that are working well.
• Cannot join or do not have access to other zanidatamab studies.
• Women who can have children and men who are not sterile must use effective birth control during the study and for 12 months after the last dose. Men must also avoid donating sperm during this time.

Exclusion Criteria

• Participating in other drug studies within 3 weeks before starting zanidatamab.
• Received cancer treatment within 3 weeks before starting zanidatamab.
• Had radiation therapy within 2 weeks before starting zanidatamab.
• Have untreated or unstable brain lesions needing immediate treatment or causing symptoms.
• Had radiation for brain lesions within 4 weeks before starting zanidatamab.
• Have a history of or ongoing leptomeningeal disease unless symptom-free.
• Have unresolved liver or bile duct issues or complications from recent procedures.
• Have active hepatitis.
• Have uncontrolled HIV.
• Are pregnant, breastfeeding, or planning a pregnancy.
• Have had a heart attack or severe heart issues in the past 6 months.
• Have a specific heart rhythm issue (QTcF > 470 ms).
• Have uncontrolled pancreatitis or severe liver disease.