This Phase 1, first-in-human (FIH), clinical study of CC-92328 will explore the safety, tolerability and preliminary biological and clinical activity of CC-92328 as a single-agent in the setting of relapsed and/or refractory multiple myeloma (R/R MM). The study will be conducted in two parts: monotherapy dose escalation (Part A) and monotherapy dose expansion (Part B).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
26
CC-92328
Local Institution - 104
Birmingham, Alabama, United States
Local Institution - 105
Scottsdale, Arizona, United States
Local Institution - 106
Tampa, Florida, United States
Dose-Limiting Toxicities (DLTs)
Are defined as toxicities that meet the protocol-specified criteria occurring within the DLT assessment window (Cycle 1, Days 1 to 28) except those that are clearly and incontrovertibly due to the underlying disease or extraneous causes.
Time frame: Up to 28 days after the first dose
Maximum Tolerated Dose (MTD)
Defined as the highest dose at which less than 33% of the population treated with CC-92328 experience a dose-limiting toxicity (DLT) in the first cycle and at least 6 evaluable participants have been treated at this dose level.
Time frame: Up to 12 weeks after the last dose
Incidence of Adverse Events (AEs)
Type, frequency, seriousness, severity and relationship of AEs to CC-92328.
Time frame: Up to 12 weeks after the last dose
Preliminary Efficacy - Overall Response Rate (ORR)
Defined as the proportion of participants who achieve a partial response (PR) or better according to IMWG response criteria.
Time frame: Up to approximately 2 years
Preliminary Efficacy - Time to response
Defined as the time from the first CC-92328 dose date to the date of first documented response (PR or better).
Time frame: Up to approximately 2 years
Preliminary Efficacy - Duration of response
Defined as the time from the earliest date of documented response (≥ PR) to the first documented disease progression or death, whichever occurs first.
Time frame: Up to approximately 2 years
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Local Institution - 108
New York, New York, United States
Local Institution - 107
New York, New York, United States
Local Institution - 101
Milwaukee, Wisconsin, United States
Local Institution - 201
Calgary, Alberta, Canada
Local Institution - 204
Edmonton, Alberta, Canada
Local Institution - 203
Halifax, Nova Scotia, Canada
Local Institution - 202
Toronto, Ontario, Canada
...and 5 more locations
Preliminary Efficacy - Progression-free Survival (PFS)
Defined as the time from the first dose of CC-92328 to pharmacodynamics (PD) or death from any cause, whichever occurs first.
Time frame: Up to approximately 2 years
Preliminary Efficacy - Overall Survival (OS)
Defined as the time from the first dose of CC-92328 to death from any cause.
Time frame: Up to approximately 2 years
Pharmacokinetics - Cmax
Maximum serum concentration of drug.
Time frame: Day 1 to 9 weeks after last dose of study drug
Pharmacokinetics - Cmin
Minimum serum concentration of drug.
Time frame: Day 1 to 9 weeks after last dose of study drug
Pharmacokinetics - AUC
Area under the curve.
Time frame: Day 1 to 9 weeks after last dose of study drug
Pharmacokinetics - tmax
Time to peak (maximum) serum concentration.
Time frame: Day 1 to 9 weeks after last dose of study drug
Pharmacokinetics - t1/2
Half-life.
Time frame: Day 1 to 9 weeks after last dose of study drug
Pharmacokinetics - CL
Total body clearance of the drug from the serum.
Time frame: Day 1 to 9 weeks after last dose of study drug
Pharmacokinetics - Vd
Volume of distribution.
Time frame: Day 1 to 9 weeks after last dose of study drug
Pharmacokinetics - Accumulation index of CC-92328
Calculated from the serum concentration-time data of CC-92328 using non-compartment methods.
Time frame: Day 1 to 9 weeks after last dose of study drug
Presence of Anti-CC92328 antibodies (ADA)
Determined using a validated bridging immunoassay with electrochemiluminescence detection.
Time frame: Day 1 to 9 weeks after last dose of study drug
Frequency of Anti-CC92328 antibodies (ADA)
Determined using a validated bridging immunoassay with electrochemiluminescence detection.
Time frame: Day 1 to 9 weeks after last dose of study drug