Study of BMS-663513 in Patients With Advanced Cancer

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

Status

Terminated

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00309023

Enrollment

115

Registered

2006-03-31

Start date

2005-12-31

Completion date

2009-09-30

Last updated

2015-10-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tumors

Keywords

Advanced Solid Tumors

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.

Interventions

DRUGBMS-663513

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

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	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

Measure	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

Countries

Canada, France, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 28, 2026