What is the study drug?
The study drug, called CLR 131, is an intravenous infusion administered up to 4 times over 3 months through an IV, and each infusion takes about 20 minutes. The study drug is designed to use radiation to target the cancer in your body. Unlike other radiation therapies you may have heard of, the study drug is designed to limit exposure of your healthy, normal tissue to radiation.
Blood diseases like Waldenstrom’s Macroglobulinemia (WM) have been shown to be highly responsive to radiation therapies. Over 100 adult and pediatric cancer patients have been dosed in previous clinical studies with the study drug, including WM patients. These include previous efficacy and safety studies where CLR 131 has been shown to be safe and have activity in WM and other diseases. This has given the study team more information about how the study drug works, how safe it is, and how it might help people with multiple types of cancer.
The study drug uses a radioactive version of iodine, which the thyroid absorbs easily. Because of this, participants will take an approved drug during the study drug cycles to protect their thyroids from radiation absorption.
What is an investigational drug?
The study drug, CLR 131, is an investigational study drug. An investigational study drug is one that has not been approved by the US Food and Drug Administration (FDA) or any other regulatory agency.
Before a study drug can be approved and made available to the public, it must go through several phases of clinical research. The CLOVER-WaM study is a Phase 2 study. Watch the video below for more information about the different phases.