Health Trials

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

ConditionsColon CarcinomaColorectal CarcinomaRectal CarcinomaStage I Colon Cancer AJCC v8Stage I Colorectal Cancer AJCC v8Stage I Rectal Cancer AJCC v8Stage II Colon Cancer AJCC v8Stage II Colorectal Cancer AJCC v8Stage II Rectal Cancer AJCC v8Stage III Colon Cancer AJCC v8Stage III Colorectal Cancer AJCC v8Stage III Rectal Cancer AJCC v8
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorEmory University

About this trial

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 criteria

Qualifiers

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 Tumors (RECIST) 1.1

Disqualifiers

Participants with stage IV colon and rectal cancer even if curative intent resection is planned

HER2 expression that does not meet documented inclusion criteria

RAS mutation

MSI-H or mismatch repair deficient rectal cancer

Trial design

Treatments tested in this trial

  • Zanidatamab
  • Resection
  • Patient Observation
  • Echocardiography Test
  • Multigated Acquisition Scan
  • Endoscopic Procedure
  • Computed Tomography
  • Magnetic Resonance Imaging
  • Biospecimen Collection
  • Biopsy Procedure
  • Digital Rectal Examination
  • Electronic Health Record Review

Treatment groups

38 Participants
are divided into 2 treatment groups

Locations

4
Emory Saint Joseph's Hospital30342, AtlantaGeorgia, United States
Emory University Hospital30322, AtlantaGeorgia, United States
Emory University Hospital Midtown30308, AtlantaGeorgia, United States
Emory Decatur Hospital30033, DecaturGeorgia, United States

Sponsors and collaborators

Emory University

Lead sponsor

National Cancer Institute (NCI)

Collaborator

Source ClinicalTrials.gov