Phase 2 Study of Zanidatamab for Patients with HER2-positive Tumors

Inclusion Criteria

• Must be 18 years or older.
• Have advanced solid tumors that cannot be surgically removed or have spread, except for certain types of biliary tract cancer.
• Have tried at least one previous treatment for advanced cancer, but it was not successful, and no other proven treatments are available.
• Have not received HER2-targeted therapy before (for Cohort 1 only).
• For breast cancer or certain stomach cancers, previous HER2-targeted therapy is allowed, and treatment with trastuzumab deruxtecan is required.
• Tumors must show high levels of HER2 (IHC 3+).
• Must provide a tumor sample for HER2 testing.
• Have at least one tumor that can be measured by scans.
• Be in good general health with an ECOG performance status of 0 or 1.
• Have a life expectancy of at least 3 months.
• If there is a history of treated brain metastases, they must be stable and meet specific conditions.
• Have adequate organ function.
• Women of childbearing potential must have a negative pregnancy test.
• Agree to use two methods of birth control if of childbearing potential.

Exclusion Criteria

• Have known or suspected cancer spread to the brain or untreated brain metastasis.
• Have serious heart disease that is not controlled.
• Have ongoing side effects from previous cancer treatments.
• Have an uncontrolled infection or need IV antibiotics, antivirals, or antifungals.
• Have HIV infection.
• Have active hepatitis B or C infection.
• Have an active COVID-19 infection.
• Have a severe allergy to monoclonal antibodies or similar drugs.
• Have a serious medical or psychiatric condition that would interfere with treatment.
• Have any condition that would make participation unsafe or affect study results.
• Have received HER2-targeted therapy before (for Cohort 1 only).
• Have a history of major surgery or trauma.
• Have received cancer treatment or investigational therapy recently.
• Have participated in a previous zanidatamab study or received zanidatamab before.
• Have colorectal cancer with specific genetic mutations.
• Have non-small cell lung cancer with specific genetic mutations.
• Are pregnant, breastfeeding, or planning a pregnancy.