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

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).

Trial Details

NCT ID
NCT07405476
Phase
PHASE2
Sponsor
Emory University
Status
RECRUITING
Cancer Type
Colorectal Cancer
Interventions
  • Zanidatamab
  • Resection
  • Patient Observation
  • Echocardiography Test
  • Multigated Acquisition Scan
  • Endoscopic Procedure
Locations (sample)
  • Atlanta, Georgia, United States|33.749,-84.38798
  • Atlanta, Georgia, United States|33.749,-84.38798
  • Atlanta, Georgia, United States|33.749,-84.38798
  • Decatur, Georgia, United States|33.77483,-84.29631

Key Eligibility Criteria

  • Histologically or cytologically confirmed colon and/or rectal cancer planned for curative intent treatment at gastrointestinal clinics of Emory Uni…
  • Tumors must be HER2+ve (human epidermal growth factor receptor 2 \[HER2\] overexpression 3+ immunohistochemistry \[IHC\] or 2+ by IHC and positive …
  • Tumors must have RAS wildtype genotype
  • Radiologically measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1

For full eligibility, visit ClinicalTrials.gov.

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