RecruitingPhase 2NCT07405476

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

A Phase II Clinical Trial of Neoadjuvant Zanidatamab for HER2+ Localized Colorectal Cancer


Sponsor

Emory University

Enrollment

38 participants

Start Date

Apr 7, 2026

Study Type

INTERVENTIONAL

Conditions

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).


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying Biopsy Procedure, a procedure called Biospecimen Collection, and others for people with colon carcinoma, colorectal carcinoma, and other related conditions. The study is currently recruiting participants at 4 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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

PROCEDUREMagnetic Resonance Imaging

Undergo MRI

PROCEDUREBiospecimen Collection

Undergo blood and/or archival tissue sample collection

PROCEDUREBiopsy Procedure

Undergo biopsy

PROCEDUREDigital Rectal Examination

Undergo digital rectal examination

OTHERElectronic Health Record Review

Ancillary studies


Locations(4)

Emory University Hospital Midtown

Atlanta, Georgia, United States

Emory University Hospital

Atlanta, Georgia, United States

Emory Saint Joseph's Hospital

Atlanta, Georgia, United States

Emory Decatur Hospital

Decatur, Georgia, United States

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NCT07405476


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