Study CC-90002-AML-001 is an open-label, Phase 1 dose escalation (Part A) and expansion (Part B), clinical study of CC-90002, administered by intravenous (IV) infusion, in subjects with relapsed and/or primary refractory AML and high-risk MDS. The study will explore escalating doses of CC-90002 using a 3 + 3 dose escalation design in Part A, followed by dose expansion in Part B. The primary objective is to determine the safety and tolerability of CC-90002 and also to define the non-tolerated dose (NTD), the maximum tolerated dose (MTD) and/or the recommended Phase 2 dose (RP2D) of CC-90002.
In both Part A and Part B, treatments will be administered in two phases starting with an induction phase followed by a maintenance phase. During the induction phase, treatments will be administered in 42-day cycles in Cycles 1 through 4. Following completion of Cycle 4 in the induction phase, subjects with non-progressive disease will enter the maintenance phase. During the maintenance phase, treatments will be administered in 28 day cycles. Subjects may continue CC-90002 for up to a maximum of 2 years (eg, induction phase Cycles 1 through 4 and maintenance phase Cycles 5 through 24) or until clinically significant disease progression, the occurrence of intolerable toxicity, or physician/subject decision to discontinue CC-90002, whichever comes first.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
28
Monoclonal Ab to CD47
Mayo Clinic Phoenix
Phoenix, Arizona, United States
UCLA Division of Hematology Oncology
Los Angeles, California, United States
Yale Cancer Center
New Haven, Connecticut, United States
University of Chicago
Chicago, Illinois, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Dose-limiting Toxicity (DLT)
Number of participants with a DLT
Time frame: Up to 26 months
Non-tolerated Dose (NTD)
The NTD is defined as the dose at which 2 or more of up to 6 evaluable subjects in a cohort experience a DLT in Cycle 1
Time frame: Up to 26 months
Maximum tolerated dose (MTD)
The MTD is defined as the last dose level(s) below the NTD with 0 or 1 out of 6 evaluable subjects experiencing a DLT during Cycle 1.
Time frame: Up to 26 months
Preliminary Efficacy of CC-90002
Determined by response rates of acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) by disease-appropriate response criteria.
Time frame: Up to 35 months
Pharmacokinetics-Cmax
Maximum observed concentration in serum
Time frame: Up to 35 months
Pharmacokinetics-AUC
Area under the serum concentration - time curve
Time frame: Up to 35 months
Pharmacokinetics-Tmax
Time to peak (maximum) serum concentration
Time frame: Up to 35 months
Pharmacokinetics-T 1/2
Terminal half-life (T 1/2)
Time frame: Up to 35 months
Pharmacokinetics- CL
Total body clearance of the drug from the serum
Time frame: Up to 35 months
Pharmacokinetics- Vss
Volume of distribution at steady-state
Time frame: Up to 35 months
Anti-Drug Antibodies (ADAs)
Determine the presence and frequency of anti-drug antibodies
Time frame: Up to 35 months
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