A Phase II Clinical Trial of Neoadjuvant Zanidatamab for HER2+ Localized Colorectal Cancer
Emory University
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).
Description
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\…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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…
Interventions
- BiologicalZanidatamab
Given IV
- ProcedureResection
Undergo surgical resection
- OtherPatient Observation
Undergo observation
- ProcedureEchocardiography Test
Undergo echocardiography
- ProcedureMultigated Acquisition Scan
Undergo MUGA scan
- ProcedureEndoscopic Procedure
Undergo sigmoidscopy
- ProcedureComputed Tomography
Undergo CT
Locations (4)
- Emory University Hospital MidtownAtlanta, Georgia
- Emory University HospitalAtlanta, Georgia
- Emory Saint Joseph's HospitalAtlanta, Georgia
- Emory Decatur HospitalDecatur, Georgia