A study of pumitamig and a drug combination versus bevacizumab and a drug combination for patients with untreated, unresectable, or metastatic colorectal cancer
This study is designed to compare the effectiveness of different treatment combinations for people with Colorectal Cancer that has not been treated before, cannot be removed by surgery, or has spread to other parts of the body. The research focuses on comparing a combination involving the drug pumitamig, also known as BNT327, with a standard treatment combination that includes bevacizumab.
The treatment groups will receive various medications. One group will receive a combination of pumitamig with several chemotherapy drugs, including oxaliplatin, calcium folinate, fluorouracil, irinotecan hydrochloride trihydrate, and capecitabine. These drugs are administered through different methods, such as an infusion, which is a liquid medicine delivered directly into a vein, or by oral use, which means taking the medicine by mouth. The other group will receive a combination of bevacizumab along with a set of chemotherapy drugs.
The study is divided into two stages. The first stage aims to see how many people experience a reduction in tumor size after receiving the treatment. The second stage focuses on observing how long the treatment keeps the cancer from growing or spreading further. Throughout the process, information is gathered to understand how well the medicines work and how they are tolerated by the body.
Who Can Join the Study?
You must be at least 18 years old.
You must have colorectal cancer (cancer in the large intestine or rectum) that has returned, spread to other parts of the body, or cannot be removed through surgery (an operation to cut out the tumor).
You must not have received any previous cancer treatments.
You must not have a specific type of colorectal cancer known as dMMR/MSI-H, which refers to certain genetic changes in how cells repair their DNA.
You must not have a BRAF V600E gene mutation, which is a specific change or error in the DNA that can cause cancer cells to grow.
Your cancer must be large enough or in a location that can be seen and measured using a scan (an imaging test like a CT or MRI).
Who Cannot Join the Study?
You cannot participate if your cancer has spread to the brain, spinal cord, or nearby areas and has not been treated (received medical care to stop or manage the disease).
You cannot participate if you have had another type of active cancer (cancer that is currently growing or spreading) within the last 2 years, unless it was a low-risk case that was cured locally (successfully treated in one specific area).
You cannot participate if you have serious heart problems, such as a recent heart attack (when blood flow to the heart is blocked), a stroke (when blood flow to the brain is blocked), blocked arteries (narrowing of the tubes that carry blood), uncontrolled high blood pressure, or certain genetic heart rhythm issues (irregular heartbeats caused by your DNA).
You cannot participate if you have already taken checkpoint inhibitors (medicines that help the immune system fight cancer), CD137 agonists (a type of drug that stimulates the immune system), or chemotherapy (medicine used to kill cancer cells).
Pumitamig is a medication being tested in this study to see how well it works when combined with other cancer treatments. It is given through an IV infusion.
Oxaliplatin is a type of chemotherapy medicine used to treat cancer. It is administered as a solution through an IV infusion.
Calcium folinate is a medication used alongside certain chemotherapy drugs to help manage how the body reacts to the treatment or to improve its effectiveness. It is given as an injection.
Fluorouracil is a common chemotherapy drug used to treat various types of cancer. It is administered as a solution through an IV injection or infusion.
Capecitabine is a chemotherapy medication that is taken by mouth in pill form.
Irinotecan is a chemotherapy drug used to treat cancer. It is administered as a solution through an IV infusion.
Bevacizumab is a medication used as a comparison in this study to see how the new treatment performs against current standard care. It is given through an IV infusion.
Colorectal cancer – This disease occurs when abnormal cells form in the colon or the rectum. These cells grow uncontrollably and can form a mass known as a tumor. As the condition progresses, the cancer cells may spread from their original location to nearby tissues or distant organs in the body. In some cases, the tumor becomes difficult to remove through surgery. The disease can also present in a state where it has already moved to other parts of the body.
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