Study of G-202 (Mipsagargin) as Second-Line Therapy Following Sorafenib in Hepatocellular Carcinoma
Status:
Completed
Trial end date:
2015-03-01
Target enrollment:
Participant gender:
Summary
Hepatocellular carcinoma (HCC) is the fifth most common type of cancer worldwide and the
third most common cause of death from cancer. Sorafenib is the only approved therapy for
treatment of advanced HCC, and there is a need to identify more drugs that are beneficial for
these patients without unacceptable side effects. Prodrug chemotherapy is an approach in
which an inactive non-toxic agent is administered to the patient and gets activated within
the body at specific locations, resulting in a higher concentration of the cytotoxic form at
a tumor location while avoiding general side effects. G-202 (mipsagargin) is an example of
prodrug chemotherapy. It is activated by Prostate Specific Memory Antigen (PSMA), which is
expressed by some cancer cells and in the blood vessels of most solid tumors, but not by
normal cells or blood vessels in normal tissue. It is believed that activation of the prodrug
G-202 will allow the drug to kill cancer cells. This study will evaluate the activity and
safety of G-202 in patients with hepatocellular carcinoma who have progressed after taking
sorafenib. The study will evaluate clinical activity and safety of G-202 administered by
intravenous infusion on three consecutive days of a 28-day cycle.