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.
Single group
Zanidatamab
DrugAdministered by intravenous (IV) infusion
Confirmed Objective Response Rate (cORR) per RECIST Version 1.1, as assessed by ICR
The Independent Central Review (ICR) assessed cORR is defined as the proportion of participants who had a best overall response of Complete Response (CR), or Partial Response (PR) based on Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
Duration of Response (DOR) Per RECIST Version 1.1, as assessed by ICR
ICR assessed DOR is defined as the time in months from the first objective response (CR or PR) that is subsequently confirmed to documented progressive disease (PD) per RECIST v1.1 or death from any cause.
cORR by RECIST Version 1.1, as assessed by Investigator
Investigator assessed cORR is defined as the proportion of participants who had a best overall response of Complete Response (CR), or Partial Response (PR) based on Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
Duration of Response (DOR) Per RECIST Version 1.1, as assessed by Investigator
Investigator assessed DOR is defined as the time in months from the first objective response (CR or PR) that is subsequently confirmed to documented progressive disease (PD) per RECIST v1.1 or death from any cause.
Time to Response (TTR), as assessed by ICR
ICR assessed TTR is defined as the time from the first dosing date to the first objective response (CR or PR) per RECIST v1.1.
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Jazz Pharmaceuticals
Lead sponsor
Jazz Pharmaceuticals Ireland Limited
Collaborator
