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

Status

Terminated

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00351325

Enrollment

Registered

2006-07-12

Start date

2007-09-30

Completion date

2009-03-31

Last updated

2009-09-04

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

Conditions

Advanced Solid Malignancies

Brief summary

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.

Interventions

DRUGBMS-663513

mg/kg, IV, 0.3, 1, 3, 10 mg/kg, q 3 wks, up to 24 weeks

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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	throughout the study

Secondary

Measure	Time frame
Explore PK and PD associations of BMS-663513 and the effect of BMS-663513 on immune system markers.	throughout the study
Describe anti-tumor activity	throughout the study
Obtain tissue or ascites for exploratory research	throughout the study

Countries

Canada, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026