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
Subjects will be enrolled sequentially into 5 planned dose cohorts according to a standard,
dose escalation study design. A disease assessment will be performed at study week 5 (+/- 3
days) by the investigator. The assessment will be based both on changes in clinical
symptoms, and radiographic images. Subjects without evidence of disease progression may
receive AGS-16M18 extended therapy at the dose and schedule of their assigned cohort until
disease progression or intolerability of AGS-16M18. Disease assessments will be performed
every 8 weeks during the extended period. A safety follow-up visit will occur 4 weeks after
the last infusion of AGS-16M18.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Incidence of adverse events
Throughout the treatment
No
Use Central Contact
Study Director
Agensys, Inc.
United States: Food and Drug Administration
2007002
NCT00816686
October 2008
April 2010
Name | Location |
---|---|
Albany, New York 12208 | |
Baltimore, Maryland 21287 |