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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 CenterIndianapolis, Indiana  46202-5265
Beth Israel Deaconess Medical CenterBoston, Massachusetts  02215
Dartmouth-Hitchcock Medical CenterLebanon, New Hampshire  03756
City of Hope National Medical CenterLos Angeles, California  91010
Yale University School Of MedicineNew Haven, Connecticut  06520
Hillman Cancer CenterPittsburg, Pennsylvania  15232