This study will test the safety and efficacy of FOR46 given every 21 days to patients with relapsed or refractory multiple myeloma. The name of the study drug involved in this study is: FOR46 for Injection
This study is designed to evaluate the safety, tolerability and antitumor activity of FOR46 in patients with relapsed or refractory multiple myeloma. This study will be conducted in two parts: Dose escalation: This part will evaluate increasing doses of FOR46 to identify the maximum tolerated dose (MTD). The first patient enrolled on the study will receive the lowest dose of FOR46. Once this dose is shown to be safe, a second patient will be enrolled at the next higher dose. Patients will continue to be enrolled into either single or multiple patient groups receiving increasing doses until the MTD is reached. Dose expansion: This part of the study will further evaluate the safety, tolerability and antitumor activity of FOR46 at a dose shown to be safe in the dose escalation part of the study.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
31
FOR46 is an intravenously (IV) administered antibody-drug conjugate (ADC) directed against CD46
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States
University of Colorado Cancer Center
Aurora, Colorado, United States
Winship Cancer Institute, Emory University
Atlanta, Georgia, United States
Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University
Incidence of adverse events
Number of patients with treatment-related adverse events as assessed by NCI CTCAE v5.0.
Time frame: Through 1 month following last dose
Occurrence of dose-limiting toxicities
The severity and incidence of dose-limiting toxicities related to escalating dose levels of FOR46
Time frame: Through 1 month following last dose
Disease response
Overall response rate of FOR46, defined as all responses greater than or equal to a partial response, complete response, stringent complete response, or minimal residual disease negativity
Time frame: 6 months
Characterize FOR46 plasma concentration
FOR46 maximum plasma concentration
Time frame: Through 1 month following last dose
Characterize the FOR46 area under the curve
FOR46 area under the plasma concentration-time curve
Time frame: Through 1 month following last dose
Characterize FOR46 elimination
FOR46 elimination half-life
Time frame: Through 1 month following last dose
Antidrug Antibodies
Change from baseline in serum levels of antidrug antibodies
Time frame: Through 1 month following last dose
Duration of response
Assessed by IMWG criteria
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Baltimore, Maryland, United States
Karmanos Cancer Institute
Detroit, Michigan, United States
Washington University in St. Louis-Siteman Cancer Center
St Louis, Missouri, United States
Icahn School of Medicine at Mt. Sinai
New York, New York, United States
Time frame: From first dose through 6 months following last dose
Progression-free survival
Assessed by IMWG criteria
Time frame: From first dose through 6 months following last dose
Time to progression
Assessed by IMWG criteria
Time frame: From first dose through 6 months following last dose