A Phase I/II Study of CR011-vcMMAE in Subjects With Unresectable Stage III or Stage IV Melanoma

Inclusion Criteria: * Male or female with age ≥ 18 years. * Progressive or new metastatic melanoma, stage III or IV. * Measurable disease by CT / MRI * Failure of no more than 1 line of prior cytotoxic therapy. * Adequate bone marrow, renal and hepatic function * Leukocytes ≥ 3000/mm3, ANC ≥ 1,500 cells/mm3, Platelets ≥ 100,000/mm3 * Hemoglobin ≥ 10 g/dL (transfusion allowed) * Total bilirubin ≤ 1.5 x upper normal limit (UNL) * AST (SGOT), ALT (SGPT) ≤ 3.0 x UNL (≤ 5.0 x UNL may be acceptable) * Serum creatinine ≤ 1.5 mg/dL or calculated creatinine clearance \> 45 mL/min/1.73 m2 * PT/aPTT \< 1.5 x UNL or within therapeutic range via anti-coagulation therapy * Karnofsky PS ≥ 70%. * Estimated life expectancy \> 3 months. * Signed informed consent approved IRB and ability to comply with the study or monitoring procedures. * Subjects with evaluable disease are eligible in dose-escalation cohorts Exclusion Criteria: * Prior therapies for disease under study less than 4 weeks prior to enrollment. * Major surgery or trauma within 4 weeks of enrollment. * Active brain metastases * Active chronic inflammatory, autoimmunity, immunodeficiency disease, and vascular or hemorrhagic disorders. * History of allergic reactions to dolastatin, auristatin or compounds of similar composition. * Significant cardiovascular disease * Other malignancies * Pregnancy or breast feeding * Refusal or inability to use effective means of contraception (for men, and women with childbearing potential) * History of or test-positive to HIV, or hepatitis B or C