This is a dose escalation study of CS-1008 (humanized anti-DR5 antibody) to determine the recommended Phase 2 dose and the maximum tolerated dose. Drug will be administered for six weeks and possibly up to 12 weeks depending on response.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
40
University of Alabama at Birmingham
Birmingham, Alabama, United States
To determine the recommended Phase 2 dose
To investigate the pharmacokinetics of CS-1008 administered weekly
To characterize the immunogenicity of CS-1008 by monitoring for anti-CS-1008 antibodies
To study potential biomarkers of CS-1008 activity
To make preliminary assessments of anti-tumor effects of CS-1008
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