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NCT00775502 Clinical Trial

Phase 1/2 Study of Anti GM-2 Monoclonal Antibody To Treat Multiple Myeloma

Multiple Myeloma Clinical Trial

Official title:
Open-Label, Multi-Center, Dose Escalation Phase 1/2 Study of Anti-GM2 Ganglioside Monoclonal Antibody BIW-8962 as Monotherapy in Subjects With Previously Treated Multiple Myeloma

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00775502
Other study ID # BIW-8962-001
Secondary ID
Status Terminated
Phase Phase 1
First received
Last updated
Start date October 2008
Est. completion date October 2011

Study information
Verified date April 2024
Source Kyowa Kirin Co., Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study will test the ability of a specially designed monoclonal antibody to destroy multiple myeloma cells. This antibody is unique in its ability to promote the death of multiple myeloma cells by processes known as antibody dependent cellular cytotoxicity (ADCC)and complement dependent cytotoxicity (CDC). The study is designed to determine both the optimal dose of the antibody to destroy multiple myeloma cells and frequency of dosing.

Description:

BIW-8962 is a monoclonal antibody which targets the GM-2 ganglioside which is expressed at high levels on the surface of multiple myeloma cells. This is a Phase 1/2 study design. The Phase 1 component will establish the active biologic dose (ABD) or the maximum tolerated dose (MTD) as well as the appropriate dosing frequency based on the pharmacokinetics of the antibody and approximately 45 subjects will be enrolled in this part of the study. The initial dosing frequency will be every two weeks and the doses to be tested will range from 0.03 mg/kg to 10 mg/kg. Once the recommended Phase 2 dose and frequency have been established in Phase 1, the efficacy of the drug will be investigated in approximately 35 subjects in Phase 2. The study did not proceed beyond the Phase 1a portion. On 30 Nov 2010, Kyowa Hakko Kirin Pharma, Inc. (KKP) notified Investigators of the decision to terminate BIW-8962-001 due to a lack of efficacy in Multiple Myeloma. The Phase 1 Part B and the Phase 2 components of the study were not conducted. The study was terminated and summarized in an abbreviated clinical study report (submitted 26 June 2012; SN045). Kyowa Kirin Pharma has no current plans to pursue the use of BIW8962 in multiple myeloma.

Recruitment information / eligibility
Status Terminated
Enrollment 23
Est. completion date October 2011
Est. primary completion date May 2011
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria: - Relapsed or refractory myeloma - M-protein in serum and/or urine by IMWG criteria. - Bone marrow plasma cells or plasmacytoma - Related organ or tissue impairment (CRAB) - Subjects without detectable M protein are eligible if they have an abnormal serum free light chain ratio (FLC) or if they have at least 10% plasma cells in the bone marrow Exclusion Criteria: - Ongoing infection - Cardiac disease - Uncontrolled hypertension - Active liver disease

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• BIW-8962
Intravenous administration of liquid dosage form. Doses 0.03, 0.10, 0.30, 1.0, 3.0, and 10 mg/kg. Frequency is once every two weeks. Duration is 6 months

Locations
Country Name City State
United States Robert H. Lurie Comprehensive Cancer Center, Northwestern University Chicago Illinois
United States Taussig Cancer Center- Cleveland Clinic Cleveland Ohio
United States Karmanos Cancer Institute Detroit Michigan
United States Duke Medical Center Durham North Carolina
United States H. Lee Moffitt Cancer Center & Research Institute Tampa Florida

Sponsors (2)
Lead Sponsor Collaborator
Kyowa Kirin Co., Ltd. Kyowa Hakko Kirin Pharma, Inc.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Serum M protein levels one month
Secondary Time to progression or death 6 months
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