Clinical trial · Interventional
Safety Study of Human IgM (MORAb-028) to Treat Metastatic Melanoma
A Phase 1 Clinical Trial of Intra-Tumoral Injection of Human IgM Monoclonal Antibody (MORAb-028) to the Ganglioside GD2 in Subjects With Injectable Metastatic Melanoma
NCT01123304CI-TRIAL-00015114terminatedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): This study has been terminated due to lack of availability of investigational product.
Summary
Brief summary (as posted)
This research is being done to find out the safety of MORAb-028 in subjects with metastatic melanoma.
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 |
|---|---|---|---|
| Melanoma | Melanoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MORAb028 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- MORAb 028
- interventionNames
- Drug: MORAb028
Primary outcomes (1)
- measure
- Safety of multiple intralesional administration of MORAb-028
- timeFrame
- Day 33
- description
- After each patient completes study treatment the patient is evaluated for dose limiting toxicities (DLTs) up to 1 week after their last dose (at day 33)
Secondary outcomes (1)
- measure
- Maximum tolerated dose of intralesional administration of MORAb-028
- timeFrame
- 22 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed AJCC Stage IIIB, IIIC or IV melanoma with injectable metastases (in transit, intradermal, or subcutaneous nodules) * Tumor accessible to intra-tumoral injections * Cumulative tumor volume great enough to accept MORAb-028 injections for a given dose level, based on intent to inject at a concentration of 1 mg/cm3 Exclusion Criteria: * Are candidates for curative surgical excision or lymphadenectomy * Prior non-surgical treatment within 4 weeks * Known central nervous system (CNS) tumor involvement or metastases * Hypersensitivity to MORAb-028
References
Publications (0)
Data not yet available
No reference posted for this study.