Actively Recruiting
Phase 2 Study of Zanidatamab for Previously Treated HER2-Expressing Solid Tumors Evaluating Safety and Effectiveness in Advanced Cancer
Led by Jazz Pharmaceuticals · Updated on 2026-07-10
200
Participants Needed
28
Research Sites
52 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating zanidatamab for treating adults with previously treated solid tumors that overexpress the HER2 protein at a high level IHC 3. This Phase 2 study focuses on participants whose tumors have progressed after at least one prior systemic treatment and who have no other confirmed beneficial treatment options. The study excludes certain cancers like biliary tract cancer and considers prior HER2 therapy differently across tumor cohorts. Participants receive zanidatamab through intravenous infusion. The study includes a single treatment group with no placebo comparison. Treatment continues as per protocol with monitoring for responses and safety. The study collects tumor samples centrally to confirm HER2 status and requires measurable disease for evaluation. Various cohorts have specific prior treatment requirements. During the study, participants undergo assessments including tumor response evaluation by independent review and investigators using standard criteria RECIST 1.1. The trial monitors treatment safety, side effects, drug levels in the blood, and immune reactions to the drug. Participants will be followed for up to 2.5 years for response and safety, and overall survival is tracked for up to 3.5 years, with regular visits to assess health status and treatment effects.
CONDITIONS
Brief Title
A Phase 2 Study of Zanidatamab in Patients With HER2-expressing Tumors
Research Team
C
Clinical Trial Disclosure & Transparency
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