Clinical trial · Interventional
Phase 1/2 Study of Anti GM-2 Monoclonal Antibody To Treat Multiple Myeloma
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): lack of efficacy in Multiple myeloma
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BIW-8962 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- BIW-8962, monoclonal antibody
- interventionNames
- Drug: BIW-8962
Primary outcomes (1)
- measure
- Serum M protein levels
- timeFrame
- one month
Secondary outcomes (1)
- measure
- Time to progression or death
- timeFrame
- 6 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDBaz RC, Zonder JA, Gasparetto C, Reu FJ, Strout V. Phase I Study of Anti-GM2 Ganglioside Monoclonal Antibody BIW-8962 as Monotherapy in Patients with Previously Treated Multiple Myeloma. Oncol Ther. 2016;4(2):287-301. doi: 10.1007/s40487-016-0034-y. Epub 2016 Nov 2. PMID 28261656