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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01211691
Recruitment Status : Suspended (KaloBios to Wind Down Operations)
First Posted : September 29, 2010
Last Update Posted : November 17, 2015
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Myelodysplastic Syndrome (MDS) Myelofibrosis (MF) Drug: KB004, Monoclonal Antibody Phase 1 Phase 2

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Study of the Anti-EphA3 Monoclonal Antibody KB004 in Subjects With EphA3-Expressing Hematologic Malignancies
Study Start Date : September 2010
Estimated Primary Completion Date : July 2016
Estimated Study Completion Date : December 2016

Arm Intervention/treatment
Experimental: Phase 1 dose levels: KB004

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)

Drug: KB004, Monoclonal Antibody
Experimental: Phase 2 dose levels: KB004

IV infusion 1x Weekly for a 21 day dosing cycle

Subjects will be assigned to the recommended Phase 2 dose of 250 mg

Drug: KB004, Monoclonal Antibody

Primary Outcome Measures :
  1. Phase 1: Determine a possible maximum tolerated dose (MTD) [ Time Frame: Once weekly for the first three weeks of study treatment ]
  2. 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 ]

Secondary Outcome Measures :
  1. Phase 1: Examine clinical activity [ Time Frame: Evaluations at designated timepoints ]
  2. Phase 1/2: Safety and Tolerability [ Time Frame: Duration of study participation ]
  3. Phase 1/2: Pharmacokinetic profile [ Time Frame: Cycle 1: multiple timepoints. Thereafter, single samples at designated cycles ]
  4. Phase 1/2: Assess immunogenicity [ Time Frame: Cycle 1: multiple timepoints. Thereafter, single samples at designated cycles ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Key Inclusion Criteria (Phase 1):

- Confirmed hematologic malignancy, including Acute Myeloid Leukemia (AML), Chronic Lymphocytic Leukemia (CLL), Chronic Myelogenous Leukemia (CML), Acute Lymphocytic Leukemia (ALL), Myelodysplastic Syndrome (MDS), Multiple Myeloma (MM), Myelofibrosis (MF), Myeloproliferative Neoplasms (MPN) or MDS/MPN overlap diseases. (Once Phase 2 has started subjects with AML will be eligible for inclusion in the Phase 1 portion of the study only if their malignancy has been shown to have c-Cbl mutation, trisomy 3, trisomy 11, inv(16), or elevated FLT3. [Other AML and subjects with MDS will no longer be eligible for inclusion in the Phase 1 portion of the study]).

Key Inclusion Criteria (Phase 2):

  • Part A: AML or MDS patients with an acceptable level of EphA3 expression
  • Part B: MF patients with an acceptable level of EphA3 expression

Key Inclusion Criteria (Both Phases):

  • 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

Key Exclusion Criteria (Both Phases):

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01211691

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United States, California
Palo Alto, California, United States, 94304
Sacramento, California, United States, 95817
United States, Florida
Miami, Florida, United States, 33136
Tampa, Florida, United States, 33612
United States, New York
Manhattan, New York, United States, 10029
United States, Ohio
Cleveland, Ohio, United States, 44195
United States, Texas
Houston, Texas, United States, 77030
Australia, South Australia
Adelaide, South Australia, Australia, 5000
Australia, Victoria
Prahran, Victoria, Australia, 3007
Sponsors and Collaborators
Humanigen, Inc.
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Study Director: Morgan Lam Humanigen, Inc.
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Humanigen, Inc. Identifier: NCT01211691    
Other Study ID Numbers: KB004-01
First Posted: September 29, 2010    Key Record Dates
Last Update Posted: November 17, 2015
Last Verified: November 2015
Keywords provided by Humanigen, Inc.:
Myeloproliferative Neoplasms
Additional relevant MeSH terms:
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Hematologic Neoplasms
Myelodysplastic Syndromes
Primary Myelofibrosis
Pathologic Processes
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Myeloproliferative Disorders
Neoplasms by Site
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs