A Phase I Study of AGS-16C3F in Patients with Clear Cell or Papillary Renal Cell Cancer

Protocol
12-162
Full Title
A Phase I, Open Label, Multi-center Study to Assess the Safety, Pharmacokinetics and Effectiveness of AGS-16C3F Monotherapy in Subjects with Renal Cell Carcinoma of Clear Cell or Papillary Histology
Phase
I
Purpose

The purpose of this study is to find the highest dose of an investigational drug called AGS-16C3F that can be given safely in patients with renal cell cancer that has spread despite prior therapy. Patients with the clear cell type of renal cell carcinoma are most likely to benefit from this drug; patients with non-clear cell cancers will have their tumors tested to see if they might respond to AGS-16C3F.

AGS-16C3F is an antibody-drug conjugate. It is composed of an antibody which binds to a specific receptor on cancer cells. Once there, a chemotherapy drug that is bound to the antibody can kill the cancer cell. AGS-16C3F is given intravenously (by vein).

Eligibility

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

  • Patients must have clear cell or papillary renal cell carcinoma that has spread despite prior therapy.
  • Patients must have recovered from the serious side effects of prior therapy before entering the study.
  • 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 about this study and to inquire about eligibility, please contact Dr. Ana M. Molina at 646-422-4313.

Disease(s)
Kidney Cancer
Locations
Related Diseases