- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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
Study Overview
Status
Conditions
Intervention / Treatment
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
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Locations
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South Australia
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Adelaide, South Australia, Australia, 5000
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Victoria
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Prahran, Victoria, Australia, 3007
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California
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Palo Alto, California, United States, 94304
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Sacramento, California, United States, 95817
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Florida
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Miami, Florida, United States, 33136
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Tampa, Florida, United States, 33612
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New York
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Manhattan, New York, United States, 10029
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Ohio
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Cleveland, Ohio, United States, 44195
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Texas
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Houston, Texas, United States, 77030
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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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) |
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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 |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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Phase 1: Determine a possible maximum tolerated dose (MTD)
Time Frame: Once weekly for the first three weeks of study treatment
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Once weekly for the first three weeks of study treatment
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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
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Evaluations at designated timepoints
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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Phase 1: Examine clinical activity
Time Frame: Evaluations at designated timepoints
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Evaluations at designated timepoints
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Phase 1/2: Safety and Tolerability
Time Frame: Duration of study participation
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Duration of study participation
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Phase 1/2: Pharmacokinetic profile
Time Frame: Cycle 1: multiple timepoints. Thereafter, single samples at designated cycles
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Cycle 1: multiple timepoints. Thereafter, single samples at designated cycles
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Phase 1/2: Assess immunogenicity
Time Frame: Cycle 1: multiple timepoints. Thereafter, single samples at designated cycles
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Cycle 1: multiple timepoints. Thereafter, single samples at designated cycles
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Morgan Lam, Humanigen, Inc.
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Neoplasms by Site
- Disease
- Bone Marrow Diseases
- Hematologic Diseases
- Myeloproliferative Disorders
- Precancerous Conditions
- Neoplasms
- Syndrome
- Myelodysplastic Syndromes
- Hematologic Neoplasms
- Primary Myelofibrosis
- Preleukemia
- Physiological Effects of Drugs
- Immunologic Factors
- Antibodies
- Antibodies, Monoclonal
Other Study ID Numbers
- KB004-01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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