Clinical Trial

Zanidatamab Before Surgery for the Treatment of HER2 Positive Colon and Rectal Cancer in Patients Planned for Curative Intent Treatment

Recruiting Phase 2
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Summary
This phase II trial studies how well giving zanidatamab before surgery (neoadjuvant) works in treating patients with colon and rectal cancer that is human epidermal growth factor receptor 2 positive (HER2+ve) who are planned for curative intent treatment. Zanidatamab is a monoclonal antibody that may interfere with the ability of tumor cells to grow and spread. A monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens).
Protocol Amendment History 2 changes
critical Recruitment opened 2026-04-18
notable Trial sites expanded: 1 -> 4 locations 2026-04-18
Trial Details
NCT Number NCT07405476
Lead Sponsor Emory University
Collaborators: National Cancer Institute (NCI)
Conditions Colon Carcinoma, Colorectal Carcinoma, Rectal Carcinoma, Stage I Colon Cancer AJCC v8, Stage I Colorectal Cancer AJCC v8, Stage I Rectal Cancer AJCC v8, Stage II Colon Cancer AJCC v8, Stage II Colorectal Cancer AJCC v8 +4 more
Enrollment 38 participants
Start Date 2026-04-07
Primary Completion 2028-12-18 (estimated)
Study Completion 2029-12-18 (estimated)
Updated on ClinicalTrials.gov 2026-04-17