Myelodysplastic Syndromes Clinical Trial
Official title:
A Phase 1, Open-label, Dose Finding Study of CC-90002, a Monoclonal Antibody Directed Against CD47, in Subjects With Acute Myeloid Leukemia and High-Risk Myelodsplastic Syndrome
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. ;
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