Study on Zanidatamab Before Surgery for Treating HER2 Positive Colon and Rectal Cancer
Sponsor: Emory University
ClinicalTrials ID:NCT07405476
This clinical trial is exploring the use of zanidatamab, a monoclonal antibody, given before surgery to treat patients with HER2 positive colon and rectal cancer. The study aims to see if this treatment can help control the cancer before surgery.
Patient Parameters
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Program Overview
This study is investigating how well the drug zanidatamab works when given before surgery to patients with colon and rectal cancer that is HER2 positive. Zanidatamab is a type of protein that targets specific molecules on cancer cells, potentially stopping them from growing and spreading. The trial is focused on patients who are planned for treatment with the goal of curing the cancer.
Description
The main goal of this study is to see how effective zanidatamab is when used before surgery in patients with HER2 positive colon and rectal cancer. Researchers want to determine if this treatment can shrink the cancer and make it easier to remove during surgery. They are also looking at how safe and feasible it is to use zanidatamab in this way.
Patients with HER2 positive colon cancer will receive zanidatamab through an IV every 14 days for up to 4 cycles, unless the cancer progresses or side effects become unacceptable. After this, they will have surgery to remove the cancer and may receive additional chemotherapy as needed. Patients with HER2 positive rectal cancer will receive zanidatamab in the same way for up to 12 cycles, followed by surgery or observation.
Throughout the study, patients will undergo various tests, including heart scans, imaging tests like CT or MRI, and blood tests. Tissue samples will also be collected to help researchers understand how the treatment is working. After completing the study treatment, patients will have follow-up visits at 30 days and then every 12 weeks for up to 2 years.
Eligibility Criteria
Inclusion Criteria
- Diagnosed with colon or rectal cancer that is planned for treatment aimed at curing the cancer.
- Cancer must be HER2 positive, confirmed by specific lab tests.
- Cancer must not have a RAS mutation.
- Cancer must be measurable by standard imaging criteria.
- Age 18 years or older.
- Good overall health with a performance status score of 0 to 2.
- Adequate blood cell counts and organ function as determined by specific tests.
- Women of childbearing potential must have a negative pregnancy test and agree to use contraception during the study and for 3 months after.
- Willingness to comply with study visits and procedures, including blood sample collection.
- Signed informed consent acknowledging understanding of the study and its potential risks and benefits.
Exclusion Criteria
- Stage IV colon or rectal cancer, even if surgery is planned.
- HER2 expression that does not meet the study's criteria.
- Cancer with a RAS mutation.
- Rectal cancer with specific genetic features (MSI-H or mismatch repair deficiency).
- Significant heart disease or recent heart attack.
- Use of other investigational drugs or devices within 28 days before starting the study.
- History of severe allergic reactions to similar drugs.
- Uncontrolled illnesses that could interfere with study participation.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Emory University Hospital Midtown | 30308 | Atlanta | Georgia |
| Emory University Hospital | 30322 | Atlanta | Georgia |
| Emory Saint Joseph's Hospital | 30342 | Atlanta | Georgia |
| Emory Decatur Hospital | 30033 | Decatur | Georgia |
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