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A Phase I, 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


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Both
Tumors

Thank you

Trial Information

A Phase I, 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


Inclusion Criteria:



- 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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To assess the safety and tolerability of BMS-663513 in the range of 0.3 mg/kg to 15 mg/kg administered once every 3 weeks

Outcome Time Frame:

throughout the study

Safety Issue:

Yes

Principal Investigator

Bristol-Myers Squibb

Investigator Role:

Study Director

Investigator Affiliation:

Bristol-Myers Squibb

Authority:

United States: Food and Drug Administration

Study ID:

CA186-001

NCT ID:

NCT00309023

Start Date:

December 2005

Completion Date:

July 2009

Related Keywords:

  • Tumors
  • Advanced Solid Tumors

Name

Location
Indiana University Cancer Center Indianapolis, Indiana  46202-5265
Beth Israel Deaconess Medical Center Boston, Massachusetts  02215
Dartmouth-Hitchcock Medical Center Lebanon, New Hampshire  03756
City of Hope National Medical Center Los Angeles, California  91010
Yale University School Of Medicine New Haven, Connecticut  06520
Hillman Cancer Center Pittsburg, Pennsylvania  15232