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

November 13, 2015 updated by: Humanigen, Inc.

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

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.

Study Overview

Status

Suspended

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

Interventional

Enrollment (Anticipated)

120

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • South Australia
      • Adelaide, South Australia, Australia, 5000
    • Victoria
      • Prahran, Victoria, Australia, 3007
  • United States
    • California
      • Palo Alto, California, United States, 94304
      • Sacramento, California, United States, 95817
    • Florida
      • Miami, Florida, United States, 33136
      • Tampa, Florida, United States, 33612
    • New York
      • Manhattan, New York, United States, 10029
    • Ohio
      • Cleveland, Ohio, United States, 44195
    • Texas
      • Houston, Texas, United States, 77030

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Phase 1: Determine a possible maximum tolerated dose (MTD)
Time Frame: Once weekly for the first three weeks of study treatment
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
Time Frame: Evaluations at designated timepoints
Evaluations at designated timepoints

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Humanigen, Inc.

Investigators

  • Study Director: Morgan Lam, Humanigen, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2010

Primary Completion (Anticipated)

July 1, 2016

Study Completion (Anticipated)

December 1, 2016

Study Registration Dates

First Submitted

September 24, 2010

First Submitted That Met QC Criteria

September 28, 2010

First Posted (Estimate)

September 29, 2010

Study Record Updates

Last Update Posted (Estimate)

November 17, 2015

Last Update Submitted That Met QC Criteria

November 13, 2015

Last Verified

November 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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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