The purpose of this study is to evaluate the safety and pharmacokinetics and assess the immunogenicity and effectiveness of AGS-16C3F in subjects with renal cell cancer (RCC).
The study has two components. The first aims to establish a safe dose for AGS-16C3F. Once identified, the safety and effectiveness will be tested in additional subjects with either clear cell or papillary histology in expanded cohorts.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
34
intravenous (IV) infusion
Site US00005 University of Michigan Medical Center
Ann Arbor, Michigan, United States
Site US00003 Karmanos Cancer Institute
Detroit, Michigan, United States
Site US00004 Roswell Park Cancer Institute
Buffalo, New York, United States
Incidence of Adverse Events
Time frame: 24 months
Pharmacokinetic profile for total antibody (TAb), antibody drug conjugate (ADC), and monomethyl auristatin F (MMAF): Ceoi or Cmax, Ctrough, Tmax, AUCτ, t1/2, CL, and Vss
Concentration at end of infusion (Ceoi) or maximum observed concentrations (Cmax), Trough concentration (Ctrough), time to maximum concentration (Tmax), partial area under the serum concentration-time curve (AUCτ), terminal or apparent half-life (t1/2), systemic clearance (CL), and volume of distribution at steady state (Vss)
Time frame: Days 1, 2, 3, 4, 8, 15, 22, 43, 64, 65, 66, 67, 71, 78, and 92
Incidence of antidrug antibody formation to human native antibody (AGS-16C) and antibody drug conjugate (AGS-16C3F)
Time frame: 24 months
Tumor response: objective response rate
Determined from the subjects' best response and will include complete response (CR) and partial response (PR)
Time frame: 24 months
Tumor response: disease control rate
Determined from the subjects' best response will include complete response (CR) partial response (PR), and stable disease (SD)
Time frame: 24 months
Tumor response: Changes in bone scans
Time frame: Baseline, Week 13 and every 12 weeks thereafter
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Site US00002 Memorial Sloan-Kettering Cancer Center
New York, New York, United States
Site US00001 Seattle Cancer Care Alliance
Seattle, Washington, United States
Site CA00006 Cross Cancer Institute
Edmonton, Alberta, Canada
Site CA00008 British Columbia Cancer Agency
Vancouver, British Columbia, Canada
Site CA00009 London Health Sciences Centre
London, Ontario, Canada
Site CA00007 Jewish General Hospital
Montreal, Quebec, Canada