This study tests the safety of a drug called SGN-CD352A, to find out what its side effects are. SGN-CD352A will be given every 4 weeks to a small group of patients with multiple myeloma.
The study will have 2 parts. In the first part, different doses of SGN-CD352A will be given to different patients (each individual patient will get the same dose for all treatments). The doses will be very low at the start of the trial, and will increase only when the lower dose levels are proven safe. In the second part of the study, up to 2 dose levels that are both safe and show promising activity against MM will be given to more patients
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
27
On the first day of each 28-day cycle, SGN-CD352A will be given IV. The dose of SGN-CD352A is different in each cohort of the study, with the lowest dose in Cohort -1 (4 mcg/kg) and the highest in Cohort 6 (65 mcg/kg). Patients can only be enrolled into a higher dose level arm if lower doses have proven safe.
Mayo Clinic Arizona
Scottsdale, Arizona, United States
City of Hope National Medical Center
Duarte, California, United States
Winship Cancer Institute / Emory University School of Medicine
Atlanta, Georgia, United States
Type, incidence, severity, seriousness, and relatedness of adverse events (including laboratory abnormalities)
Time frame: Through 1 month following last dose.
Incidence of dose-limiting toxicity
Time frame: During Cycle 1 (Trial Days 1-28)
Overall survival
Time frame: Up to approximately 3 years
Progression-free survival
Time frame: Up to approximately 3 years
Duration of objective response
Time frame: Up to approximately 3 years
Duration of complete response
Time frame: Up to approximately 3 years
Objective response rate
Time frame: Up to approximately 3 years
Complete response rate
Time frame: Up to approximately 3 years
Incidence of antitherapeutic antibodies (ATA)
Time frame: Up to approximately 3 years
Blood concentrations of SGN-CD352A and metabolites
Time frame: Up to approximately 3 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Holden Comprehensive Cancer Center / University of Iowa
Iowa City, Iowa, United States
Karmanos Cancer Institute / Wayne State University
Detroit, Michigan, United States
Washington University School of Medicine
St Louis, Missouri, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
Weill Cornell Medical College
New York, New York, United States
Charles A. Sammons Cancer Center / Baylor University Medical Center
Dallas, Texas, United States
Swedish Cancer Institute
Seattle, Washington, United States
...and 1 more locations