Safety Study of Human IgM (MORAb-028) to Treat Metastatic Melanoma

Morphotek

Status and phase: Terminated; Phase 1

Conditions: Melanoma

Treatments: Drug: MORAb028

Study type: Interventional

Funder types: Industry

Identifiers

NCT01123304

MORAb028-002

Details and patient eligibility

About

This research is being done to find out the safety of MORAb-028 in subjects with metastatic melanoma.

Enrollment: 18 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

18 participants in 1 patient group

MORAb 028

Experimental group

Treatment:

Drug: MORAb028