Actively Recruiting
A Phase II Clinical Trial of Neoadjuvant Zanidatamab for HER2 Positive Localized Colon and Rectal Cancer
Led by Emory University · Updated on 2026-04-17
38
Participants Needed
4
Research Sites
52 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
Researchers are studying how well zanidatamab works when given before surgery (neoadjuvant) for patients with HER2 positive colon and rectal cancer who are planned for curative treatment. Zanidatamab is a monoclonal antibody designed to interfere with tumor cell growth and spread. This phase II trial aims to determine the activity, efficacy, safety, and feasibility of this treatment in locally advanced colorectal cancer with specific genetic profiles. Patients with HER2 positive colon cancer are assigned to cohort 1 and receive zanidatamab intravenously every 14 days for up to 4 cycles before surgery, followed by standard chemotherapy. Patients with HER2 positive rectal cancer are in cohort 2 and receive the drug every 14 days for up to 12 cycles, with optional surgery or observation afterward. Both groups undergo various scans, biopsies, and sample collections during the study. Participants will have regular evaluations including imaging tests like CT or MRI, heart function tests, and blood sample collections throughout the study. After treatment completion, follow-up visits occur at 30 days and then every 12 weeks for up to 2 years. Researchers will measure tumor response through pathology and imaging, monitor safety, and track recurrence and survival over time.
CONDITIONS
Brief 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 (3+ by IHC or 2+ by IHC with positive FISH or HER2 amplification by sequencing)
- Tumors must have RAS wildtype genotype
- Radiologically measurable disease based on RECIST 1.1
- Age 18 years or older
- ECOG performance status of 0 to 2 (Karnofsky 50% or higher)
- Platelet count greater than 100,000 cells/µl 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 less than or equal to 3 times upper limit of normal within 28 days before treatment
- ALT less than or equal to 3 times upper limit of normal within 28 days before treatment
- Total bilirubin less than or equal to 1.5 times upper limit of normal (or up to 3 times for 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 at least 50% within 28 days before treatment
- Females of child-bearing potential must have a negative pregnancy test before starting therapy
- Both females of child-bearing potential and men must agree to use adequate contraception during and for 3 months after study drug administration
- Willingness and ability to comply with study visits, drug plan, lab tests, procedures, and restrictions
- Signed informed consent acknowledging understanding of study and experimental nature
You will not qualify if you...
- Stage IV colon or rectal cancer even if curative intent resection is planned
- HER2 expression not meeting inclusion criteria
- Presence of RAS mutation
- MSI-H or mismatch repair deficient rectal cancer
- Clinically significant cardiac disease including ventricular arrhythmia needing treatment, uncontrolled hypertension, or symptomatic congestive heart failure
- Myocardial infarction or unstable angina within 6 months before treatment
- Previous anticancer therapy-related congestive heart failure greater than grade 1 or not fully resolved
- Use of other investigational agents or devices within 28 days before starting study drug
- History of allergic reactions to similar compounds
- Uncontrolled illnesses including active infection, symptomatic heart failure, unstable angina, cardiac arrhythmia, or psychiatric/social conditions limiting study compliance
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Duration - Up to 8 weeks for Cohort 1 or up to 24 weeks for Cohort 2
Participants receive zanidatamab intravenously every 14 days. Cohort 1 receives up to 4 cycles and then undergoes surgical resection followed by standard adjuvant chemotherapy. Cohort 2 receives up to 12 cycles and then optionally undergoes surgical resection or observation as per standard care. Participants also undergo echocardiography or MUGA scan, sigmoidscopy, CT or MRI, blood sample collection, and digital rectal exam (Cohort 2 only) during this period.
1 infusion visit every 14 days during treatment and additional visits for imaging and procedures
Duration - Up to 2 years
Participants are followed up for safety and disease status after treatment completion, with visits at 30 days post-treatment and then every 12 weeks for up to 2 years.
Visits at 30 days post-treatment and then every 12 weeks
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
P
Patrick Sullivan, MD, FACS
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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