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

• Status: Completed
• Trial end date: 2011-05-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will evaluate the safety, tolerability and pharmacokinetics of CR011-vcMMAE in patients who have unresectable stage III or stage IV melanoma and have failed no more than 1 line of prior cytotoxic therapy. CR011-vcMMAE will be administered intravenously (IV) once every 3 weeks at escalating doses until the maximum tolerated dose (MTD) is reached. Once the MTD is defined, 18-32 patients will be enrolled to further evaluate the safety and efficacy of CR011-vcMMAE at this dose level. Additional dosing schedules of CR011-vcMMAE will also be explored.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: CuraGen Corporation
• Treatments: Antibodies, Monoclonal; Glembatumumab vedotin

Criteria

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