Phase I study to define the safety profile and pharmacokinetic parameters of SGN-35 in patients with relapsed/refractory CD30-positive hematologic malignancies. This is a single-arm, open-label, Phase I dose escalation study designed to define the MTD, PK, immunogenicity and anti-tumor activity of SGN-35 in patients with relapsed/refractory CD30-positive hematologic malignancies.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
45
Every 21 days. Dose Escalating. 0.1 - 3.6 mg/kg
University of Alabama at Birmingham
Birmingham, Alabama, United States
Washington University
St Louis, Missouri, United States
Weill Cornell Medical College
New York, New York, United States
University of Texas/MD Anderson Cancer Center
Houston, Texas, United States
Incidence of adverse events and laboratory abnormalities
Time frame: 1 month after last dose
PK profile
Time frame: 2 months after last dose
Immunogenicity (anti-SGN-35 antibodies)
Time frame: 1 month after last dose
Anti-tumor activity
Time frame: 1 month after last dose
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