Study of KB004 in Subjects With Hematologic Malignancies (Myelodysplastic Syndrome, MDS, Myelofibrosis, MF)
- Conditions
- Myelodysplastic Syndrome (MDS)Myelofibrosis (MF)
- Interventions
- Drug: KB004, Monoclonal Antibody
- Registration Number
- NCT01211691
- Lead Sponsor
- Humanigen, Inc.
- Brief Summary
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.
- Detailed Description
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
Recruitment & Eligibility
- Status
- SUSPENDED
- Sex
- All
- Target Recruitment
- 120
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Phase 1 dose levels: KB004 KB004, Monoclonal Antibody IV infusion 1x Weekly for a 21 day dosing cycle Subjects with heme malignancies will be assigned to one of 11 planned KB004 (dose levels (20mg, 40mg, 70mg, 100mg, 140mg, 190mg, 250mg, 330mg) Phase 2 dose levels: KB004 KB004, Monoclonal Antibody IV infusion 1x Weekly for a 21 day dosing cycle Subjects will be assigned to the recommended Phase 2 dose of 250 mg
- Primary Outcome Measures
Name Time Method Phase 1: Determine a possible maximum tolerated dose (MTD) 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 Evaluations at designated timepoints
- Secondary Outcome Measures
Name Time Method Phase 1/2: Assess immunogenicity Cycle 1: multiple timepoints. Thereafter, single samples at designated cycles Phase 1/2: Safety and Tolerability Duration of study participation Phase 1: Examine clinical activity Evaluations at designated timepoints Phase 1/2: Pharmacokinetic profile Cycle 1: multiple timepoints. Thereafter, single samples at designated cycles