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