This is a phase 1, open-label, dose-escalation clinical trial to evaluate the safety of SGN-75 in combination with everolimus in patients with CD70-positive metastatic renal cell carcinoma.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
4
1-2 mg/kg IV every 21 days
10 mg PO daily
Stanford Cancer Center
Stanford, California, United States
Rocky Mountain Cancer Centers - Midtown
Denver, Colorado, United States
Karmanos Cancer Institute / Wayne State University
Detroit, Michigan, United States
Incidence of adverse events and laboratory abnormalities
Time frame: Through 1 month post last dose
Best clinical response according to RECIST Version 1.1
Time frame: Through 1 month post last dose
Progression-free survival
Time frame: Until disease progression or start of new anticancer treatment, an expected average of 6 months
Overall survival
Time frame: Until death or study closure, an expected average of 1 year
Blood concentrations of SGN-75 and metabolites
Time frame: Cycle 1: pre-dose, 30 minutes, and 2, 4, 8, 24, 168, and 336 hours post dose start; pre-dose in subsequent cycles, and 1 month post last dose
Incidence of antitherapeutic antibodies
Time frame: Pre-dose in most cycles and 1 month post last dose
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Memorial Sloan Kettering Cancer Center
New York, New York, United States
UNC Lineberger Comprehensive Cancer Center / University of North Carolina
Chapel Hill, North Carolina, United States
Miriam Hospital, The
Providence, Rhode Island, United States
Sarah Cannon Research Institute
Nashville, Tennessee, United States
Seattle Cancer Care Alliance / University of Washington
Seattle, Washington, United States