The purpose of this study is to evaluate a multi-dose regimen of SGN-30, a novel chimeric monoclonal antibody (mAb), in patients with refractory or recurrent CD30+ hematologic malignancies. This is a single-arm, open-label phase I/II study designed to define the toxicity profile, pharmacokinetic (PK) profile, and anti-tumor activity of a multi-dose regimen of SGN-30 in patients with refractory or recurrent CD30+ hematologic malignancies. The phase I study will be a modified dose escalation of SGN-30. Based on preclinical pharmacology and toxicokinetics (TK) and the first use in human single-dose phase I study, SGN-30 will be administered on a weekly schedule. An initial dose of 2 mg/kg will escalate until the maximum tolerated dose (MTD) has been reached or until a weekly dose of 12 mg/kg is achieved.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
70
University of Alabama, Birmingham
Birmingham, Alabama, United States
USC Norris Cancer Center
Los Angeles, California, United States
University of Miami
Miami, Florida, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Siteman Cancer Center
St Louis, Missouri, United States
University of Nebraska
Omaha, Nebraska, United States
Cornell Medical College, New York Presbyterian
New York, New York, United States
University of Rochester
Rochester, New York, United States
MD Anderson Cancer Center
Houston, Texas, United States
University of Washington
Seattle, Washington, United States
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.