This study will test the safety and activity of SGN-CD48A in patients with multiple myeloma. SGN-CD48A will be given on Days 1, 8, and 15 of a 28-day cycle. Prior to protocol amendment 2, SGN-CD48A was given every 3 weeks.
This study is designed to evaluate the safety, tolerability, and antitumor activity of SGN-CD48A in patients with relapsed or refractory multiple myeloma. This study will be conducted in 2 parts: 1. Dose escalation: This part will evaluate increasing doses of SGN-CD48A to identify the maximum tolerated dose. The first group of patients enrolled on the study will receive the lowest dose of SGN-CD48A. Once this dose is shown to be safe, a second group of patients will be enrolled at the next higher dose. Patients will continue to be enrolled in groups receiving increasing doses until the maximum tolerated dose level is reached. Patients can only be enrolled into a higher dose level once the lower doses have been demonstrated safe. Dose escalation will be conducted using a modified toxicity probability interval (mTPI) study design. 2. Dose expansion: This part will further evaluate the safety, tolerability, and antitumor activity of up to 2 dose levels of SGN-CD48A shown to be safe in the first part of the trial.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
14
Intravenous (IV) infusion on days 1, 8, and 15 of a 28-day cycle
University of California at San Francisco
San Francisco, California, United States
Yale Cancer Center
New Haven, Connecticut, United States
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States
Mount Sinai Medical Center
New York, New York, United States
Type, incidence, severity, seriousness, and relatedness of adverse events
Time frame: Through 1 month following last dose
Incidence of laboratory abnormalities
Time frame: Through 1 month following last dose
Incidence of dose limiting toxicity
Time frame: Through 3 weeks following first dose
Objective response rate
The proportion of patients with stringent complete response, complete response, very good partial response, or partial response per investigator
Time frame: Through 1 month following last dose
Complete response rate
The proportion of patients with stringent complete response or complete response per investigator
Time frame: Through 1 month following last dose
Duration of objective response
Time frame: Up to approximately 3 years
Duration of complete response
Time frame: Up to approximately 3 years
Progression-free survival
Time frame: Up to approximately 3 years
Overall survival
Time frame: Up to approximately 3 years
Blood concentrations of SGN-CD48A and metabolites
Time frame: Through 1 month following last dose
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Levine Cancer Institute
Charlotte, North Carolina, United States
University of Pennsylvania / Perelman Center for Advanced Medicine
Philadelphia, Pennsylvania, United States
Incidence of antitherapeutic antibodies
Time frame: Through 1 month following last dose