The purpose of this dose escalation study is to examine the safety and pharmacokinetics (PK) of AGS-16M8F administered in subjects with advanced renal cell carcinoma.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
26
IV
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Seattle Cancer Care Alliance
Seattle, Washington, United States
Safety assessed by recording adverse events, vital signs and laboratory assessments
Time frame: For 12 weeks during treatment period and up to 4 weeks follow up
Pharmacokinetic variables assessment through analysis of blood samples
Time frame: Up to day 15 for cycle 1 and cycle 4 and pre-dose for cycles 2 and 3; every 3 weeks during the second 12 weeks of treatment; and if subject continues on study drug, every 12 weeks thereafter
Incidence of anti-AGS-16M8F antibody formation
Time frame: Baseline; up to day 64 during the first 12 weeks; and if subject continues on study drug, every 3 weeks during the second 12 weeks of treatment and every 12 weeks thereafter
Incidence of Tumor Response (complete or partial response)
Time frame: Baseline and every 12 weeks while on study drug
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