A Phase I/II Study of CR011-vcMMAE in Subjects With Unresectable Stage III or Stage IV Melanoma
- 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
- 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
- Subjects with evaluable disease are eligible in dose-escalation cohorts
- 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
- History of allergic reactions to dolastatin, auristatin or compounds of similar
- Significant cardiovascular disease
- Other malignancies
- Pregnancy or breast feeding
- Refusal or inability to use effective means of contraception (for men, and women with
- History of or test-positive to HIV, or hepatitis B or C