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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


Phase 1
18 Years
75 Years
Not Enrolling
Both
Multiple Myeloma

Thank you

Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Serum M protein levels

Outcome Time Frame:

one month

Safety Issue:

Yes

Principal Investigator

Jeffrey Zonder, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Karmanos Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

BIW-8962-001

NCT ID:

NCT00775502

Start Date:

October 2008

Completion Date:

October 2011

Related Keywords:

  • Multiple Myeloma
  • Multiple myeloma
  • GM-2 ganglioside
  • monoclonal antibody
  • Potelligent design
  • Treatment of subjects who have failed previous treatment
  • Multiple Myeloma
  • Neoplasms, Plasma Cell

Name

Location

Robert H. Lurie Comprehensive Cancer Center, Northwestern UniversityChicago, Illinois  60611
H. Lee Moffitt Cancer Center & Research InstituteTampa, Florida  33612
Karmanos Cancer InstituteDetroit, Michigan  48201
Duke Medical CenterDurham, North Carolina  
Taussig Cancer Center- Cleveland ClinicCleveland, Ohio  44195