Emory University
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).
PRIMARY OBJECTIVE: I. To determine the activity of neoadjuvant zanidatamab in HER2+ve (RAS wild type \[RAS WT\]) locally advanced colorectal cancer. SECONDARY OBJECTIVES: I. To determine the efficacy of neoadjuvant zanidatamab in HER2+ve (RAS WT) locally advanced colorectal cancer. II. To determine the feasibility and safety of neoadjuvant zanidatamab in human epidermal growth factor receptor 2 positive (HER2+) locally advanced colorectal cancer. TERTIARY/EXPLORATORY OBJECTIVE: PRIMARY OBJECTIVE: I. To determine the activity of neoadjuvant zanidatamab in HER2+ve (RAS wild type \[RAS WT\…
Inclusion Criteria: * Histologically or cytologically confirmed colon and/or rectal cancer planned for curative intent treatment at gastrointestinal clinics of Emory University's Winship Cancer Institute and collaborating centers * Tumors must be HER2+ve (human epidermal growth factor receptor 2 \[HER2\] overexpression 3+ immunohistochemistry \[IHC\] or 2+ by IHC and positive fluorescence in situ hybridization \[FISH\] or HER2 amplification by next generation sequencing) * Tumors must have RAS wildtype genotype * Radiologically measurable disease based on Response Evaluation Criteria in Solid…
Given IV
Undergo surgical resection
Undergo observation
Undergo echocardiography
Undergo MUGA scan
Undergo sigmoidscopy
Undergo CT
Undergo MRI
Undergo blood and/or archival tissue sample collection
Undergo biopsy
Undergo digital rectal examination
Ancillary studies