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

Phase 1/2 Suspended 120 enrolled Humanigen, Inc.

Non-randomizedSingle-groupOpen-labelTreatment

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.

Timeline

Start: 2010-09
Primary completion: 2016-07
Completion: 2016-12

Outcome

Outcome not reported

Stopped: “KaloBios to Wind Down Operations”

Publications

Swords RT, Greenberg PL, Wei AH, Durrant S, Advani AS, Hertzberg MS, Jonas BA, Lewis ID, Rivera G, Gratzinger D, Fan AC, Felsher DW, Cortes JE, Watts JM, Yarranton GT, Walling JM, Lancet JE. KB004, a first in class monoclonal antibody targeting the receptor tyrosine kinase EphA3, in patients with advanced hematologic malignancies: Results from a phase 1 study. Leuk Res. 2016 Nov;50:123-131. doi: 10.1016/j.leukres.2016.09.012. Epub 2016 Sep 28.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	KB004	Monoclonal antibody	20 mg	Intravenous
Subject	KB004	Monoclonal antibody	40 mg	Intravenous
Subject	KB004	Monoclonal antibody	70 mg	Intravenous
Subject	KB004	Monoclonal antibody	100 mg	Intravenous
Subject	KB004	Monoclonal antibody	140 mg	Intravenous
Subject	KB004	Monoclonal antibody	190 mg	Intravenous
Subject	KB004	Monoclonal antibody	250 mg	Intravenous
Subject	KB004	Monoclonal antibody	330 mg	Intravenous