Study Stopped
KaloBios to Wind Down Operations
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
1 other identifier
interventional
120
2 countries
9
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Sep 2010
Longer than P75 for phase_1
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2010
CompletedFirst Submitted
Initial submission to the registry
September 24, 2010
CompletedFirst Posted
Study publicly available on registry
September 29, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2016
CompletedNovember 17, 2015
November 1, 2015
5.8 years
September 24, 2010
November 13, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (4)
Phase 1: Examine clinical activity
Evaluations at designated timepoints
Phase 1/2: Safety and Tolerability
Duration of study participation
Phase 1/2: Pharmacokinetic profile
Cycle 1: multiple timepoints. Thereafter, single samples at designated cycles
Phase 1/2: Assess immunogenicity
Cycle 1: multiple timepoints. Thereafter, single samples at designated cycles
Study Arms (2)
Phase 1 dose levels: KB004
EXPERIMENTALIV 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
EXPERIMENTALIV infusion 1x Weekly for a 21 day dosing cycle Subjects will be assigned to the recommended Phase 2 dose of 250 mg
Interventions
Eligibility Criteria
You may qualify if:
- Part A: AML or MDS patients with an acceptable level of EphA3 expression
- Part B: MF patients with an acceptable level of EphA3 expression
- Confirmed hematologic malignancy refractory to or progressed following standard treatments, or subjects not considered medically suitable to receive standard of care treatment or who refuse standard of care treatment
- Acceptable level of EphA3 expression
- Eastern Cooperative Oncology Group (ECOG) ≤1
- Acceptable laboratory results
You may not qualify if:
- For subjects with AML, more than 2 prior therapies for AML (induction and consolidation with or without a hypomethylating agent given in a maintenance setting are considered 1 therapy)
- History of or current central nervous system (CNS) involvement that may increase risk of bleeding
- Recent major surgery
- Ongoing surgical or wound healing complications
- Active clinically significant bleeding
- Uncontrolled hypertension
- Significant intercurrent illness
- Known history of prolonged bleeding times or platelet dysfunction
- Active infection requiring IV antibiotics, IV antifungals, or IV antivirals within 2 weeks prior to Cycle 1, Day 1
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Humanigen, Inc.lead
Study Sites (9)
Unknown Facility
Palo Alto, California, 94304, United States
Unknown Facility
Sacramento, California, 95817, United States
Unknown Facility
Miami, Florida, 33136, United States
Unknown Facility
Tampa, Florida, 33612, United States
Unknown Facility
Manhattan, New York, 10029, United States
Unknown Facility
Cleveland, Ohio, 44195, United States
Unknown Facility
Houston, Texas, 77030, United States
Unknown Facility
Adelaide, South Australia, 5000, Australia
Unknown Facility
Prahran, Victoria, 3007, Australia
Related Publications (1)
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.
PMID: 27736729DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Morgan Lam
Humanigen, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 24, 2010
First Posted
September 29, 2010
Study Start
September 1, 2010
Primary Completion
July 1, 2016
Study Completion
December 1, 2016
Last Updated
November 17, 2015
Record last verified: 2015-11