Study of BMS-663513 in Patients With Advanced Cancer

Bristol-Myers Squibb (BMS)

Status and phase: Terminated; Phase 2; Phase 1

Conditions: Tumors

Treatments: Drug: BMS-663513

Study type: Interventional

Funder types: Industry

Identifiers

NCT00309023

CA186-001

Details and patient eligibility

About

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.

Enrollment: 115 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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115 participants in 1 patient group

dose escalation

Experimental group

Treatment:

Drug: BMS-663513