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Clinical Trial Details — Status: Suspended

Administrative data

NCT number NCT01211691
Other study ID # KB004-01
Secondary ID
Status Suspended
Phase Phase 1/Phase 2
First received September 24, 2010
Last updated November 13, 2015
Start date September 2010
Est. completion date December 2016

Study information

Verified date November 2015
Source KaloBios Pharmaceuticals
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.


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


Recruitment information / eligibility

Status Suspended
Enrollment 120
Est. completion date December 2016
Est. primary completion date July 2016
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Drug:
KB004, Monoclonal Antibody


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
KaloBios Pharmaceuticals

Countries where clinical trial is conducted

United States,  Australia, 

Outcome

Type Measure Description Time frame Safety issue
Primary Phase 1: Determine a possible maximum tolerated dose (MTD) Once weekly for the first three weeks of study treatment Yes
Primary Phase 2: To characterize preliminary clinical activity based on the International Working Group (IWG) criteria specific to the hematologic malignancy Evaluations at designated timepoints Yes
Secondary Phase 1: Examine clinical activity Evaluations at designated timepoints No
Secondary Phase 1/2: Safety and Tolerability Duration of study participation Yes
Secondary Phase 1/2: Pharmacokinetic profile Cycle 1: multiple timepoints. Thereafter, single samples at designated cycles No
Secondary Phase 1/2: Assess immunogenicity Cycle 1: multiple timepoints. Thereafter, single samples at designated cycles Yes
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