A Phase 2 Study of Zanidatamab in Patients With HER2-expressing Tumors (NCT06695845) | Clinical Trial Compass
RecruitingPhase 2
A Phase 2 Study of Zanidatamab in Patients With HER2-expressing Tumors
United States200 participantsStarted 2025-01-14
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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.
✓. Presence of at least 1 measurable lesion as assessed by Independent Central Review (ICR) based on Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
✓. Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
✓. Has a life expectancy of at least 3 months, in the opinion of the investigator.
✓. Participants with history of treated and stable CNS metastases are eligible, provided the following criteria are met:
Exclusion criteria
✕. Has known or suspected leptomeningeal disease and/or untreated brain metastasis.
What they're measuring
1
Confirmed Objective Response Rate (cORR) per RECIST Version 1.1, as assessed by ICR
. Has uncontrolled or significant cardiovascular disease
✕. Has ongoing toxicity related to prior cancer therapy
✕. Has uncontrolled infection or requiring IV antibiotics, antivirals, or antifungals.
✕. Has known Human Immunodeficiency Virus (HIV) infection.
✕. Has active hepatitis B or C infection.
✕. Has an active SARS-CoV-2 infection.
✕. Has a history of life-threatening hypersensitivity to monoclonal antibody (mAbs) or to recombinant proteins or excipients in the drug formulation of zanidatamab.