Phase II Study of Zanidatamab Before Surgery for HER2 Positive Colon and Rectal Cancer with Curative Intent

What this Trial Is About

Researchers are studying how well zanidatamab works when given before surgery neoadjuvant for patients with HER2 positive colon and rectal cancer who are planned for curative treatment. Zanidatamab is a monoclonal antibody designed to interfere with tumor cell growth and spread. This phase II trial aims to determine the activity, efficacy, safety, and feasibility of this treatment in locally advanced colorectal cancer with specific genetic profiles. Patients with HER2 positive colon cancer are assigned to cohort 1 and receive zanidatamab intravenously every 14 days for up to 4 cycles before surgery, followed by standard chemotherapy. Patients with HER2 positive rectal cancer are in cohort 2 and receive the drug every 14 days for up to 12 cycles, with optional surgery or observation afterward. Both groups undergo various scans, biopsies, and sample collections during the study. Participants will have regular evaluations including imaging tests like CT or MRI, heart function tests, and blood sample collections throughout the study. After treatment completion, follow-up visits occur at 30 days and then every 12 weeks for up to 2 years. Researchers will measure tumor response through pathology and imaging, monitor safety, and track recurrence and survival over time.

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