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
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
120
Unnamed facility
Palo Alto, California, United States
Unnamed facility
Sacramento, California, United States
Unnamed facility
Miami, Florida, United States
Unnamed facility
Tampa, Florida, United States
Phase 1: Determine a possible maximum tolerated dose (MTD)
Time frame: Once weekly for the first three weeks of study treatment
Phase 2: To characterize preliminary clinical activity based on the International Working Group (IWG) criteria specific to the hematologic malignancy
Time frame: Evaluations at designated timepoints
Phase 1: Examine clinical activity
Time frame: Evaluations at designated timepoints
Phase 1/2: Safety and Tolerability
Time frame: Duration of study participation
Phase 1/2: Pharmacokinetic profile
Time frame: Cycle 1: multiple timepoints. Thereafter, single samples at designated cycles
Phase 1/2: Assess immunogenicity
Time frame: Cycle 1: multiple timepoints. Thereafter, single samples at designated cycles
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Unnamed facility
Manhattan, New York, United States
Unnamed facility
Cleveland, Ohio, United States
Unnamed facility
Houston, Texas, United States
Unnamed facility
Adelaide, South Australia, Australia
Unnamed facility
Prahran, Victoria, Australia