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Also known as Urelumab (BMS-663513), BMS-663513
Urelumab · 4 trials · 5 indications
As determined by medical review of adverse event reports, vital sign measurements, electrocardiograms (ECGs), and results of physical examination and laboratory tests During a 3 week cycle, safety labs are done on Days 1, 2, 3, 5, 8, and 15. Starting on Cycle 3, Day 1, Chemistry (excluding Liver function test (LFTs)) are to be performed on Day 1 and Day 15 of each cycle thereafter. Physical exams are done on Day 1 of each cycle. Vital signs are done on Days 1, 2, 8, and 15 at Cycle 1 and then on Days 1 and 2 of each cycle thereafter. Adverse events are collected from screening to 60 days after last dose of Urelumab
The incidence of adverse events will be tabulated and reviewed for potential significance and clinical Importance.
| Arm | Type | Description |
|---|---|---|
| Urelumab (+ Nivolumab) intravenous (IV) infusion | EXPERIMENTAL | - |
| Cohort 1: Urelumab + Cetuximab | EXPERIMENTAL | Urelumab every 3 weeks with Cetuximab weekly through Intravenous infusion |
| Cohort 2: Urelumab + Cetuximab | EXPERIMENTAL | Urelumab every 3 weeks with Cetuximab weekly through Intravenous infusion |
| Arm -1 - Urelumab + Rituximab | EXPERIMENTAL | Urelumab (BMS-663513) flat dose intravenous infusion on specified days Rituximab intravenous flat dose infusion on specified days |
| Arm 1 - Urelumab + Rituximab | EXPERIMENTAL | Urelumab (BMS-663513) flat dose intravenous infusion on specified days Rituximab intravenous flat dose infusion on specified days |
| Part 1 : Urelumab (BMS-663513) Dose escalation | EXPERIMENTAL | Urelumab (BMS-663513) solution administered intravenously on specified days |
| Part 2 : Urelumab (BMS-663513) Cohort Expansion | EXPERIMENTAL | Urelumab (BMS-663513) solution administered intravenously on specified days |
| Part 3:Urelumab (BMS-663513) Tumor-specific Cohort Expansions | EXPERIMENTAL | Enrollment of subjects of three specific tumor types \[(colorectal cancer (CRC), head and neck squamous cell carcinoma (SCCHN), and B-Cell non-Hodgkin's lymphoma (B-NHL)\] who will be treated at the Maximum Tolerated Dose (MTD) (or highest dose tested) |
| Part 4:Urelumab (BMS-663513) Cohort Expansion in B-NHL | EXPERIMENTAL | Arm A and Arm B: Urelumab (BMS-663513) liquid administered intravenously on specified days exploring q3w and q6w dosing regimen |
| Name | Type | Description |
|---|---|---|
| Urelumab | DRUG | - |
| Nivolumab | DRUG | - |
| Cetuximab | BIOLOGICAL | - |
| Rituximab | BIOLOGICAL | - |
| Urelumab (BMS-663513) | DRUG | - |
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: * Subjects with previously treated advanced malignant solid tumor * Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1 * For certain subjects, willing and able to...
Urelumab is an investigational monoclonal antibody being studied in oncology for advanced and metastatic malignant tumors, solid tumors, colorectal cancer, head and neck cancer, and B-cell malignancies including B-cell non-Hodgkin's lymphoma. It has been evaluated in Phase 1 clinical trials, both as a single agent and in combination with other therapies.
Urelumab targets TNFRSF9, also known as CD137 or 4-1BB, and acts as an agonist. By activating this receptor, the antibody is designed to stimulate immune signaling. This agonist mechanism distinguishes it from checkpoint inhibitors, which block inhibitory signals rather than activate stimulatory ones.
Urelumab is being developed by Bristol-Myers Squibb Company, which trades under the ticker BMY. The company is also known by the research code BMS-663513, which appears in the drug's development designation.
Urelumab is in Phase 1 clinical development. It is an investigational agent and has not been approved by the FDA. All of its recorded trials are Phase 1 studies, and the completed trials enrolled a total of 124 participants across the studies listed.
Urelumab has been studied in completed Phase 1 trials including NCT02534506 in Japan, NCT02110082 combining it with cetuximab in colorectal and head and neck cancer, NCT01775631 combining it with rituximab in B-cell non-Hodgkin's lymphoma, and NCT01471210 in solid tumors and relapsed or refractory B-cell non-Hodgkin's lymphoma.
Yes, Urelumab is also known as BMS-663513. BMS-663513 is the research and development code used by Bristol-Myers Squibb for the same monoclonal antibody. Both names refer to the identical investigational agent targeting TNFRSF9.