Study of BMS-663513 in Patients With Advanced Cancer

Phase 1

Terminated

Brief Summary: This is a Phase I/II, ascending, multi-dose study of BMS-663513, an agonistic anti-CD137 monoclonal antibody, administered every three weeks to patients with metastatic or locally advanced solid tumors.

Recruitment & Eligibility

Inclusion Criteria

Eastern Cooperative Oncology Group (ECOG) score of 0-1.
Measurable disease.
Absolute neutrophil count (ANC) >= 1,500 cells/mm3
Platelet count >= 100K cells/mm3
Hemoglobin >= 9.0 g/dL
Total bilirubin <= 1.5 x IULN
Alanine aminotransferase (ALT), aspartate aminotransferase (AST) and alkaline phosphatase <= 2.5 x institutional upper limit of normal (IULN)
Patients with advanced solid malignancies must have melanoma, renal or ovarian carcinoma

Exclusion Criteria

History of autoimmune diseases.
Condition requiring the continued use of systemic or topical steroids or the use of immunosuppressive agents.
Active/symptomatic brain metastasis.
History of hepatitis B or C.
Concurrent malignancy.

Arm && Interventions

Group	Intervention	Description
dose escalation	BMS-663513	-

Primary Outcome Measures

Name	Time	Method
Assess Safety (Number and distribution and severity adverse events) of subjects	Active treatment of a minimum of 3 months up until disease progression or toxicity; and long-term follow-up to assess time to progression or death will conclude 2 years after the last treatment with BMS-663513.

Secondary Outcome Measures

Name	Time	Method
Assess pharmacokinetic parameters deriving from serum concentration versus time data	Cycle 1 Day 1, Cycle 2 Day 1 and 28, Cycle 3 Day 1 and 8, and Day 1 of every cycle the subject is on study from Cycle 4 and greater; and at study discharge.
Efficacy by evaluation of tumor response	At week 12 and every 6 weeks thereafter. Follow-up up to 2 years after last dose of study drug
Assess pharmacodynamic and immune response analysis	up to 60 days after last dose of study drug

Locations (7): City Of Hope National Medical Center
🇺🇸
Duarte, California, United States
Yale University School Of Medicine
🇺🇸
New Haven, Connecticut, United States
Indiana University Cancer Center
🇺🇸
Indianapolis, Indiana, United States
Beth Israel Deaconess Medical Center
🇺🇸
Boston, Massachusetts, United States
Dartmouth-Hitchcock Medical Center
🇺🇸
Lebanon, New Hampshire, United States
Hillman Cancer Center
🇺🇸
Pittsburgh, Pennsylvania, United States
Local Institution
🇫🇷
Villejuif Cedex, France
City Of Hope National Medical Center
🇺🇸Duarte, California, United States