Efficacy Study of Pharmacokinetic(PK)/Pharmacodynamic(PD) Relationship of Monotherapy MORAb-004 in Metastatic Melanoma

Inclusion Criteria

• •Be surgically sterile or consent to use a medically acceptable method of contraception throughout the study period.
• •Histologically confirmed diagnosis of metastatic melanoma
• •At least 1 prior systemic treatment for metastatic melanoma with disease progression following treatment
• •Measurable disease, as defined by RECIST v1.1, assessed within 4 weeks prior to study entry
• •At least 3 week interval between first infusion of test article and most recent prior systemic anticancer therapy. All treatment-associated toxicity must be resolved to less than or equal to Grade 1 before the administration of MORAb-004
• •Have a life expectancy of at least 3 months as estimated by the investigator
• •Have other significant medical conditions well-controlled and stable, in the opinion of the investigator, for at least 30 days prior to Study Day 1
• •Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
• •Have sites of disease amenable to the protocol-specified biopsy (Note: All participants will have protocol-specified biopsy at Screening. The second, on-treatment biopsy will be mandatory in the first 30 randomized participants only. For all other participants, the second biopsy is optional.
• •Laboratory tests results prior to Study Day 1 within limits as outlined in protocol