Phase 1/2 Study of Anti GM-2 Monoclonal Antibody To Treat Multiple Myeloma
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.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
- Serum M protein levels [ Time Frame: one month ] [ Designated as safety issue: Yes ]
- Time to progression or death [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
|Study Start Date:||October 2008|
|Study Completion Date:||October 2011|
|Primary Completion Date:||May 2011 (Final data collection date for primary outcome measure)|
|Experimental: BIW-8962, monoclonal antibody||
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
Other Name: anti GM2 monoclonal antibody
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00775502
|United States, Florida|
|H. Lee Moffitt Cancer Center & Research Institute|
|Tampa, Florida, United States, 33612|
|United States, Illinois|
|Robert H. Lurie Comprehensive Cancer Center, Northwestern University|
|Chicago, Illinois, United States, 60611|
|United States, Michigan|
|Karmanos Cancer Institute|
|Detroit, Michigan, United States, 48201-2014|
|United States, North Carolina|
|Duke Medical Center|
|Durham, North Carolina, United States, 27705|
|United States, Ohio|
|Taussig Cancer Center- Cleveland Clinic|
|Cleveland, Ohio, United States, 44195|
|Principal Investigator:||Jeffrey Zonder, MD||Karmanos Cancer Center|