Study of BMS-663513 in Patients With Advanced Cancer

Study Overview
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Brief Summary
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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.

Official Title
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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 Malignancies

Conditions
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Tumors

Intervention / Treatment
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* Drug: BMS-663513


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: dose escalation<br> | Drug: BMS-663513<br>* mg/kg, intravenous (IV), 0.3, 1, 3, 6, 10 or 15 mg/kg, once every 3 weeks (q 3 wks), 12 weeks depending on response<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 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. | 
| Assess pharmacodynamic and immune response analysis |  | up to 60 days after last dose of study drug | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Advanced Solid Tumors