Clinical trial · Interventional
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
NCT00309023CI-TRIAL-00019434terminatedPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Tumors | Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BMS-663513 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- dose escalation
- interventionNames
- Drug: BMS-663513
Primary outcomes (1)
- measure
- Assess Safety (Number and distribution and severity adverse events) of subjects
- timeFrame
- 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 outcomes (3)
- measure
- Efficacy by evaluation of tumor response
- timeFrame
- At week 12 and every 6 weeks thereafter. Follow-up up to 2 years after last dose of study drug
- measure
- Assess pharmacokinetic parameters deriving from serum concentration versus time data
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.