The purpose of this study is to evaluate the efficacy and safety of zanidatamab for the treatment of participants with previously treated solid tumors that have Human Epidermal Growth Factor Receptor 2 (HER2) Immunohistochemistry (IHC) 3+ overexpression.
Is at least 18 years of age inclusive at the time of signing the informed consent
Participants with locally advanced, unresectable, or metastatic solid tumors (except Biliary Tract Cancer (BTC), defined as gallbladder cancer or cholangiocarcinoma) who have progressed following at least 1 prior systemic treatment for metastatic or advanced disease and have no available treatment options that have confirmed benefit. Prior treatment with HER2-targeted therapy is not permitted (Cohort 1 only). For participants with breast cancer (Cohort 2) or GEA (Cohort 3), prior HER2-targeted therapy is permitted and prior therapy with trastuzumab deruxtecan (T-DXd) is required.
HER2 overexpression (IHC 3+) must be determined by a sponsor designated central laboratory.
All participants must have adequate tumor sample for submission to allow central HER2 testing.
Has known or suspected leptomeningeal disease and/or untreated brain metastasis.
Has uncontrolled or significant cardiovascular disease
Has ongoing toxicity related to prior cancer therapy
Has uncontrolled infection or requiring IV antibiotics, antivirals, or antifungals.
Jazz Pharmaceuticals
Lead sponsor
Jazz Pharmaceuticals Ireland Limited
Collaborator