Clinical trial · Interventional
A Study of BMS-663513 Administered in Combination With Chemotherapy to Subjects With Advanced Solid Malignancies
A Phase I, Multiple Ascending Dose Study of BMS-663513, an Agonistic Anti-CD137 Monoclonal Antibody, Administered in Combination With Chemotherapy to Subjects With Advanced Solid Malignancies
NCT00351325CI-TRIAL-00002600terminatedPhase 1ClinicalTrials.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)
The purpose of this study is to assess the safety and tolerability of multiple escalating doses of BMS-663513 when given in combination with paclitaxel and carboplatin.
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 |
|---|---|---|---|
| Advanced Solid Malignancies | — | UNRESOLVED | — |
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
- To assess the safety and tolerability of multiple ascending doses of BMS-663513 when given in combination with paclitaxel and carboplatin to subjects with advanced malignancies
- timeFrame
- throughout the study
Secondary outcomes (3)
- measure
- Explore PK and PD associations of BMS-663513 and the effect of BMS-663513 on immune system markers.
- timeFrame
- throughout the study
- measure
- Describe anti-tumor activity
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Good activity level * Life expectancy of ≥ 6 months * Solid tumor malignancy for which paclitaxel and carboplatin are appropriate Exclusion Criteria: * Major surgery within 4 weeks * Any concurrent cancer * History of autoimmune diseases * Symptomatic bowel obstruction * Continued use of steroids * Symptomatic brain metastases * Current nerve damage in fingers/toes * Positive for HIV, hepatitis B/C * White blood cells \< 3,000 * Hemoglobin \< 9 * Platelets \< 100,000 * ALT/AST and/or alkaline phosphatase \>= 2.5 x ULN * Creatine \> 1.5 * Prior BMS-663513
References
Publications (0)
Data not yet available
No reference posted for this study.