A Phase I/IIa Multi-Dose Escalation Study to Evaluate Maximum Tolerated Dose (MTD), Pharmacokinetics (PK), Safety and Efficacy of BT062 in Subjects with Refractory, Relapsed or Relapsed/Refractory Multiple Myeloma
ID Number 10-1466Principal Investigator(s)
Department(s) or Division(s)
Hematology and Medical Oncology
The purpose of this study is evaluating the dose limiting toxicities (side effects that are severe enough that you cannot take any more drug at that dose) and the maximum tolerated dose (the highest dose that a human can take on an ongoing basis with minimal or mild side effects) of the compound in subjects with relapsed or relapsed/refractory multiple myeloma.
Multiple Myeloma is the second most common blood cancer illness. The disease is an abnormality of your plasma cells which is a type of blood cell that produces antibodies (special substances in the blood) which help your body fight pathogens (things such as bacteria (germs) that make us ill). Most plasma cells reside in the bone marrow (space within bones). When plasma cells become abnormal they may grow out of control and destroy surrounding bone structures. The abnormal cells may crowd out the normal components of the bone marrow resulting in a lower number of red blood cells (that provide oxygen to your body), platelets (that help form blood clots and prevent bleeding) and other white blood cells (that help fight infection) in your body. Rather than generating the antibodies that normal plasma cells create, abnormal plasma cells generate an abnormal antibody (called a monoclonal protein) on the surface of the cancerous cell which may also leak into the bloodstream or urine. The study drug BT062 is developed as an immunoconjugate. Such immunoconjugate consists of two parts, a monoclonal antibody and a cytotoxic agent. BT062 is designed to bind to these abnormal plasma cells (via the monoclonal antibody) and to destroy these abnormal plasma cells (via the cytotoxic agent) which may help to stop your disease from getting worse.
Recruiting Patients: Yes