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