Study of CC-96191 in Participants With Relapsed or Refractory Acute Myeloid Leukemia
- Registration Number
- NCT04789655
- Lead Sponsor
- Celgene
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 80
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description CC-96191 CC-96191 CC-96191 will be administered intravenously on a 28-day Cycle
- Primary Outcome Measures
Name Time Method Dose limiting toxicities (DLTs) Up to 42 days after the first dose 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.
Maximum tolerated dose (MTD) Up to 35 days after the last dose 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.
Adverse Events (AEs) Up to 35 days after the last dose Type, frequency, seriousness, severity and relationship of AEs to CC-96191
- Secondary Outcome Measures
Name Time Method Complete remission rate (CRR) Up to approximately 2 years As defined by the European Leukemia Net (ELN) AML response criteria.
Objective response rate (ORR) Up to approximately 2 years As defined by the European Leukemia Net (ELN) AML response criteria.
Progression-free survival (PFS) Up to approximately 2 years Is defined as the time from the first dose of CC-96191 to the first occurrence of disease progression or death from any cause.
Pharmacokinetics - CL Up to 35 days after last dose Total body clearance of the drug from the serum
Overall survival (OS) Up to approximately 2 years Is measured as the time from the first dose of CC-96191 to death due to any cause.
Duration of remission Up to approximately 2 years 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 to remission Up to approximately 2 years Time from the date of first dose to the earliest date of any response (CR of any type, MLFS or PR)
Pharmacokinetics - t1/2 Up to 35 days after last dose Terminal half-life
Pharmacokinetics - Vss Up to 35 days after last dose Volume of distribution at steady-state
Presence of anti-drug antibodies (ADA) Up to 35 days after last dose Detection of anti-drug antibodies in participants
Pharmacokinetics - Cmax Up to 35 days after last dose Maximum serum concentration of drug
Pharmacokinetics - AUC Up to 35 days after last dose Area under the serum concentration time-curve
Pharmacokinetics - tmax Up to 35 days after last dose Time to peak (maximum) serum concentration
Frequency of anti-drug antibodies (ADA) Up to 35 days after last dose Frequency of anti-drug antibodies in participants
Trial Locations
- Locations (14)
Local Institution - 302
🇫🇷Villejuif CEDEX, France
Local Institution - 304
🇫🇷Paris, France
Local Institution - 301
🇫🇷Pessac Cedex, France
Local Institution - 109
🇺🇸Birmingham, Alabama, United States
Local Institution - 105
🇺🇸Jacksonville, Florida, United States
Local Institution - 108
🇺🇸Atlanta, Georgia, United States
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
Local Institution - 303
🇫🇷Marseille cedex, France