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A Phase I Study of AGS-8M4 Given as Monotherapy in Patients with Advanced Ovarian Cancer

[Protocol 08-111]

Full Title :
A PHASE I, OPEN-LABEL, MULTI-CENTER, DOSE ESCALATION STUDY OF THE SAFETY AND PHARMACOKINETICS OF AGS-8M4 GIVEN AS MONOTHERAPY IN SUBJECTS WITH ADVANCED OVARIAN CANCER
Purpose :

The immune system of the body has the ability to fight and eliminate infections and cancers. Immune treatments seek to teach the immune system to find and destroy cancer cells. The purpose of this study is to find the highest dose of a new immune treatment called AGS-8M4 that can be given safely in women with advanced ovarian cancer that persists despite prior therapy, to see how patients' immune systems respond to the drug, and to determine if the drug can stop ovarian cancer from growing.

AGS-8M4 is an antibody that works by targeting a protein called AGS-8, which has been found on about 70 percent of ovarian cancer cells in laboratory studies. Laboratory studies have shown that AGS-8M4 stops ovarian cancer cell growth by inhibiting the development of blood vessels that tumors need to grow and spread.

Eligibility :

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have advanced (stage III or IV) ovarian, fallopian tube, or primary peritoneal cancer that persists or has progressed despite prior treatment that included at least one regimen with a platinum-containing drug.
  • At least 2 weeks must have passed since completion of prior chemotherapy or radiation therapy and 4 weeks since any major surgery and entry into the study, and patients must have recovered from any side effects.
  • Patients may not have had prior monoclonal antibody therapy (with the exception of bevacizumab, which is permitted).
  • Patients must be physically well enough that they are fully ambulatory, capable of all self care, and are capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
  • Patients must be age 18 or older.

For more information and to inquire about eligibility for this study, please contact Dr. Paul Sabbatini at 212-639-6423.

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