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A Phase I Study of AGS-16M18 in Patients with Advanced Renal Cell Carcinoma
[Protocol 08-086]
- Full Title :
- A PHASE 1, OPEN-LABEL, MULTI-CENTER, DOSE ESCALATION STUDY OF THE SAFETY AND PHARMACOKINETICS OF AGS-16M18 GIVEN AS MONOTHERAPY IN SUBJECTS WITH ADVANCED RENAL CELL CARCINOMA
- Purpose :
The purpose of this study is to find the highest dose of an investigational drug, AGS-16M18, that can be given safely in patients with advanced renal cell carcinoma that has continued to grow despite therapy. AGS-16M18 is a monoclonal antibody that binds to a protein found on the surface of renal cell carcinoma cells.
Laboratory studies have shown that AGS-16M18 inhibits tumor cell growth, division, and spread, and causes tumor cells to commit cellular suicide (a process called apoptosis). Laboratory studies also showed that AGS-16M18 inhibited tumor growth and, in combination with approved targeted therapies, increased antitumor activity.
- 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 has persisted despite prior treatment with at least one systemic therapy that included sunitinib, temsirolimus, or sorafenib.
- At least 4 weeks must have passed since completion of prior therapy and entry into the study, and patients must have recovered from any side effects. Patients may not have had prior treatment with a monoclonal antibody.
- 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. Glenn Kroog at 646-422-4313.
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