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