177Lu Radiolabeled Monoclonal Antibody HuJ591-GS (177Lu-J591) in Patients With Nonprostate Metastatic Solid Tumors: A Pilot Study
177Lu-J591 is made up of two compounds called J591 and 177Lutetium (177Lu) that are joined
together by a connecting molecule called "DOTA". J591 is a monoclonal antibody, or a type
of protein. 177Lu is a radioactive molecule that is being tested for the possible treatment
of cancer when joined to monoclonal antibodies. J591 attaches to a protein called prostate
specific membrane antigen (PSMA) found in the body. PSMA is mostly found in normal and
cancerous prostate cells. In addition, however, PSMA has also been found on the vasculature
(blood vessels) that supply multiple types of cancer including colorectal, kidney, bladder,
head and neck, breast, non-small cell lung, pancreas, ovary, esophagus and gliomas.
We hope that 177Lu-J591 will seek out blood vessels that supply these tumors and deliver a
dose of radiation (from the 177Lu molecule) to the areas of cancer, without affecting target
blood vessel that are not associated with the cancer.
Indium-111 (111In) is a radioactive tracer that allows special scans to be performed prior
to administration of the study drug to determine where the antibody goes in the body and to
screen the tumor's blood vessels to see if they attract J591. Again, DOTA is used to join
the radioactive material to J591. 111In-J591 is not being given to treat cancer.
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Change in tumor perfusion as based on DCE-MRI study as well as changes in cellularity as assessed using DWI.
Performed after administration of 177LuJ591 between Day 6-9 and on Day 29.
United States: Food and Drug Administration
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