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

Part of paid clinical trials in Atlanta, Georgia.

Sponsor
Emory University
Study ID
NCT07405476
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Colon Carcinoma
  • Colorectal Carcinoma
  • Rectal Carcinoma
  • Stage I Colon Cancer AJCC v8
  • Stage I Colorectal Cancer AJCC v8
  • Stage I Rectal Cancer AJCC v8
  • Stage II Colon Cancer AJCC v8
  • Stage II Colorectal Cancer AJCC v8
  • Stage II Rectal Cancer AJCC v8
  • Stage III Colon Cancer AJCC v8
  • Stage III Colorectal Cancer AJCC v8
  • Stage III Rectal Cancer AJCC v8

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Zanidatamab — BIOLOGICAL
    Given IV
  • Resection — PROCEDURE
    Undergo surgical resection
  • Patient Observation — OTHER
    Undergo observation
  • Echocardiography Test — PROCEDURE
    Undergo echocardiography
  • Multigated Acquisition Scan — PROCEDURE
    Undergo MUGA scan
  • Endoscopic Procedure — PROCEDURE
    Undergo sigmoidscopy
  • Computed Tomography — PROCEDURE
    Undergo CT
  • Magnetic Resonance Imaging — PROCEDURE
    Undergo MRI
  • Biospecimen Collection — PROCEDURE
    Undergo blood and/or archival tissue sample collection
  • Biopsy Procedure — PROCEDURE
    Undergo biopsy
  • Digital Rectal Examination — PROCEDURE
    Undergo digital rectal examination
  • Electronic Health Record Review — OTHER
    Ancillary studies

Study Details

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).

Key Dates

Start date
Apr 7, 2026
Status verified
Apr 2026
Primary completion
Dec 18, 2028
Completion
Dec 18, 2029

Study Design

Enrollment
38 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort 1 (zanidatamab, surgical resection)
    Patients receive zanidatamab IV over 90-150 minutes on day 1 of each cycle. Cycles repeat every 14 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Patients then undergo surgical resection on study followed by adjuvant chemotherapy as per standard of care. Additionally, patients undergo echocardiography or MUGA scan, sigmoidscopy, CT or MRI, and blood sample collection throughout the study. Patients also undergo archival tissue sample collection or biopsy during screening.
  • Experimental: Cohort 2 (zanidatamab)
    Patients receive zanidatamab IV over 90-150 minutes on day 1 of each cycle. Cycles repeat every 14 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Patients then optionally undergo surgical resection or observation as per standard of care. Additionally, patients undergo echocardiography or MUGA scan, sigmoidscopy, CT, MRI, blood sample collection, and digital rectal exam throughout the study. Patients also undergo archival tissue sample collection or biopsy during screening.

Primary Outcome Measure

Rate of Complete and Major Pathologic Regression (Cohort 1) [ Time Frame: At time of surgical resection ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
Emory Saint Joseph's HospitalAtlantaGeorgia30342-
Emory University HospitalAtlantaGeorgia30322
Kathleen Coleman
[email protected]
Olumide B. Gbolahan, MBBS, MSc (PRINCIPAL_INVESTIGATOR)
Emory University Hospital MidtownAtlantaGeorgia30308-
Emory Decatur HospitalDecaturGeorgia30033-

Find similar trials in Atlanta, GA

By condition
Colorectal cancer
By specialty
OncologyGI oncology
By research site
Emory Saint Joseph's Hospital· Atlanta, GAEmory University Hospital· Atlanta, GAEmory University Hospital Midtown· Atlanta, GAEmory Decatur Hospital· Decatur, GA

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