Myelodysplastic Syndrome (MDS) Clinical Trial
Official title:
Study of the Anti-EphA3 Monoclonal Antibody KB004 in Subjects With EphA3-Expressing Hematologic Malignancies
This is a global, multicenter, open-label, repeat-dose, Phase 1/2 study consisting of a Dose Escalation Phase (Phase 1) and a Cohort Expansion Phase (Phase 2). In both phases, KB004 will be administered by IV infusion once weekly as part of a 21-day dosing cycle.
The purpose of Phase 1 is to determine a maximum tolerated dose (MTD) for KB004 when
administered to subjects with hematologic malignancies who meet the entry criteria. Phase 1
has completed enrollment July of 2014, the recommended Phase 2 dose is 250 mg. AML 20 mg
Cohort completed enrollment Dec 2014.
The purpose of Phase 2 is to characterize preliminary clinical activity. The Phase 2 portion
of the study consists of two parts:
- Part A: Subjects with AML or MDS who meet the entry criteria
- Part B: Subjects with MF who meet the entry criteria
;
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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