A Phase IB Study of SGN-75 plus Everolimus in Patients with CD70-Positive Metastatic Renal Cell Cancer

Protocol
12-263
Full Title
A Phase 1b, Open-label, Dose-escalation Study to Evaluate the Safety and Tolerability of SGN-75 in Combination with Everolimus in Patients with CD70-positive Metastatic Renal Cell Carcinoma
Purpose

Everolimus is a standard chemotherapy drug used to treat a form of kidney cancer called renal cell carcinoma. However, in many patients, the cancer eventually continues to grow. In this study, researchers are determining the highest dose of an investigational drug called SGN-75 that can be given safely with everolimus in patients with metastatic renal cell carcinoma that is positive for a protein called CD70 (the target of SGN-75).

SGN-75 has two parts: one (an antibody) that attaches to CD70 on the surface of cancer cells (including some kidney cancers), and another (an anticancer drug called monomethyl auristatin F) that kills the cancer. SGN-75 is given intravenously (by vein), while everolimus is taken orally (by mouth).

Eligibility

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

  • Patients must have metastatic renal cell carcinoma that is positive for the CD70 protein.
  • Patients must have had at least one prior regimen of therapy that targeted the vascular endothelial growth factor receptor.
  • Patients may not have received prior everolimus, temsirolimus, other mTOR inhibitors, or therapy directed at CD70.
  • At least 2 weeks must have passed since completion of prior therapy and entry into the study.
  • Patients must be able to be ambulatory for more than half of their normal waking hours.
  • This study is open to patients age 18 and 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