Actively Recruiting
Zanidatamab Before Surgery for the Treatment of HER2 Positive Colon and Rectal Cancer in Patients Planned for Curative Intent Treatment
Led by Emory University · Updated on 2026-04-17
38
Participants Needed
4
Research Sites
193 weeks
Total Duration
On this page
Sponsors
E
Emory University
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Zanidatamab Before Surgery for the Treatment of HER2 Positive Colon and Rectal Cancer in Patients Planned for Curative Intent Treatment
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed colon and/or rectal cancer planned for curative intent treatment
- Tumors must be HER2 positive by immunohistochemistry or gene amplification
- Tumors must have RAS wildtype genotype
- Radiologically measurable disease based on RECIST 1.1
- Age 18 years or older
- ECOG performance status 0 to 2 (Karnofsky 50% or higher)
- Platelet count greater than 100,000 cells/ul within 28 days before treatment
- Hemoglobin greater than 9 g/dl within 28 days before treatment
- Absolute neutrophil count greater than 1000 cells/dl within 28 days before treatment
- AST and ALT less than or equal to 3 times the upper limit of normal within 28 days before treatment
- Total bilirubin less than or equal to 1.5 times ULN or up to 3 times ULN if Gilbert's disease within 28 days before treatment
- Glomerular filtration rate greater than 60 ml/min within 28 days before treatment
- Adequate cardiac function with left ventricular ejection fraction of at least 50% within 28 days before treatment
- Females of child-bearing potential must have negative pregnancy test before starting therapy
- Females of child-bearing potential and men must agree to use contraception during study and for 3 months after
- Willingness and ability to comply with study visits, drug administration, laboratory tests, and procedures
- Signed informed consent indicating awareness of disease, study procedures, experimental nature, risks, benefits, and alternatives
You will not qualify if you...
- Stage IV colon or rectal cancer even if curative intent surgery is planned
- HER2 expression not meeting inclusion criteria
- RAS mutation present
- MSI-High or mismatch repair deficient rectal cancer
- Clinically significant cardiac disease including ventricular arrhythmia, uncontrolled hypertension, or symptomatic congestive heart failure
- Myocardial infarction or unstable angina within 6 months before treatment
- Prior anticancer therapy-related congestive heart failure grade higher than 1 or unresolved
- Receiving other investigational agents or devices within 28 days before study drug
- History of allergic reactions to similar compounds as study agents
- Uncontrolled illness including active infection, symptomatic heart failure, unstable angina, cardiac arrhythmia, or psychiatric/social conditions limiting study compliance
AI-Screening
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Trial Site Locations
Total: 4 locations
1
Emory University Hospital Midtown
Atlanta, Georgia, United States, 30308
Actively Recruiting
2
Emory University Hospital
Atlanta, Georgia, United States, 30322
Actively Recruiting
3
Emory Saint Joseph's Hospital
Atlanta, Georgia, United States, 30342
Actively Recruiting
4
Emory Decatur Hospital
Decatur, Georgia, United States, 30033
Actively Recruiting
Research Team
O
Olumide B. Gbolahan, MBBS, MSc
CONTACT
P
Patrick Sullivan, MD, FACS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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