NCT01211691

Study of KB004 in Subjects With Hematologic Malignancies (Myelodysplastic Syndrome, MDS, Myelofibrosis, MF)

Study of the Anti-EphA3 Monoclonal Antibody KB004 in Subjects With EphA3-Expressing Hematologic Malignancies

• Status: Suspended
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Humanigen, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Myelodysplastic Syndrome (MDS)
• Myelofibrosis (MF)

Interventions

Type	Name	Description
DRUG	KB004, Monoclonal Antibody

Timeline

• Start date: 2010-09-01
• Primary completion: 2016-07-01
• Completion: 2016-12-01
• First posted: 2010-09-29
• Last updated: 2015-11-17

Locations

9 sites across 2 countries: United States, Australia