This Phase 1, clinical study of CC-96191 will explore the safety, tolerability and preliminary biological and clinical activity of CC-96191 as a single-agent in the setting of Relapsed or refractory acute myeloid leukemia (R/R AML). The dose escalation (Part A) of the study will explore escalating intravenous doses of CC-96191 to estimate the MTD and/or RP2D of CC-96191 as monotherapy. The expansion (Part B), will further evaluate the safety and efficacy of CC-96191 administered at or below the MTD in one or more expansion cohorts in order to determine the RP2D.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
45
CC-96191
Local Institution - 109
Birmingham, Alabama, United States
Local Institution - 105
Jacksonville, Florida, United States
Local Institution - 108
Atlanta, Georgia, 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 at least 28 and up to 42 days) that cannot be attributed to a clearly identifiable cause such as underlying illness, disease progression, other concurrent illness, or concomitant medication.
Time frame: Up to 42 days after the first dose
Maximum tolerated dose (MTD)
Is defined as the highest dose at which less than 33% of the population treated with CC-96191 experience a dose limiting toxicity (DLT) in the first cycle.
Time frame: Up to 35 days after the last dose
Adverse Events (AEs)
Type, frequency, seriousness, severity and relationship of AEs to CC-96191
Time frame: Up to 35 days after the last dose
Complete remission rate (CRR)
As defined by the European Leukemia Net (ELN) AML response criteria.
Time frame: Up to approximately 2 years
Objective response rate (ORR)
As defined by the European Leukemia Net (ELN) AML response criteria.
Time frame: Up to approximately 2 years
Progression-free survival (PFS)
Is defined as the time from the first dose of CC-96191 to the first occurrence of disease progression or death from any cause.
Time frame: Up to approximately 2 years
Overall survival (OS)
Is measured as the time from the first dose of CC-96191 to death due to any cause.
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Local Institution - 110
Rochester, Minnesota, United States
Local Institution - 101
Hackensack, New Jersey, United States
Local Institution - 102
New York, New York, United States
Local Institution - 107
Houston, Texas, United States
Local Institution - 111
Seattle, Washington, United States
Local Institution - 202
Calgary, Alberta, Canada
Local Institution - 201
Toronto, Ontario, Canada
...and 4 more locations
Time frame: Up to approximately 2 years
Duration of remission
For subjects with best response of complete remission (CR) of any type, morphologic leukemia free state (MLFS) or partial remission (PR), duration of response (DOR) is measured from the time when criteria for CR/MLFS/PR are first met (whichever is first recorded) until the first date at which relapse, or progressive disease is objectively documented
Time frame: Up to approximately 2 years
Time to remission
Time from the date of first dose to the earliest date of any response (CR of any type, MLFS or PR)
Time frame: Up to approximately 2 years
Pharmacokinetics - Cmax
Maximum serum concentration of drug
Time frame: Up to 35 days after last dose
Pharmacokinetics - AUC
Area under the serum concentration time-curve
Time frame: Up to 35 days after last dose
Pharmacokinetics - tmax
Time to peak (maximum) serum concentration
Time frame: Up to 35 days after last dose
Pharmacokinetics - t1/2
Terminal half-life
Time frame: Up to 35 days after last dose
Pharmacokinetics - CL
Total body clearance of the drug from the serum
Time frame: Up to 35 days after last dose
Pharmacokinetics - Vss
Volume of distribution at steady-state
Time frame: Up to 35 days after last dose
Presence of anti-drug antibodies (ADA)
Detection of anti-drug antibodies in participants
Time frame: Up to 35 days after last dose
Frequency of anti-drug antibodies (ADA)
Frequency of anti-drug antibodies in participants
Time frame: Up to 35 days after last dose