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Also known as BMS-936564 (Anti-CXCR4), Ulocuplumab
BMS-936564 · 1 trial · 4 indications
Safety and tolerability measured by incidence of adverse events (AEs), AEs leading to discontinuation, Serious Adverse Events (SAEs), deaths, and laboratory abnormalities
| Arm | Type | Description |
|---|---|---|
| Arm 1: Dose Escalation and Expansion cohort (AML Patients) | EXPERIMENTAL | Dose Escalation: BMS-936564 0.3-10 mg/kg solution, Intravenous, Single 60 minute infusion as monotherapy 7 days/cycle 1 and with chemotherapy for subsequent cycles (28 days/cycle) Dose Expansion: BMS-936564 maximum tolerated dose (MTD) based on dose escalation, solution, Intravenous, Single 60 minute infusion as monotherapy 7 days/cycle 1 and with chemotherapy for subsequent cycles (28 days/cycle) |
| Arm 2: Dose Expansion cohort (DLBCL Patient) | EXPERIMENTAL | BMS-936564 MTD based on Arm 1, weekly 60 minute infusion in cycle 1 (up to 56 days) and with chemotherapy for subsequent cycles (28 days/cycle) |
| Arm 3: Dose Expansion cohort (CLL Patient) | EXPERIMENTAL | BMS-936564 MTD based on Arm 1, weekly 60 minute infusion in cycle 1 (up to 56 days) and with chemotherapy for subsequent cycles (28 days/cycle) |
| Arm 4: Dose Expansion cohort (FL Patient) | EXPERIMENTAL | BMS-936564 MTD based on Arm 1, weekly 60 minute infusion in cycle 1 (up to 56 days) and with chemotherapy for subsequent cycles (28 days/cycle) |
| Name | Type | Description |
|---|---|---|
| BMS-936564 (Anti-CXCR4) | DRUG | - |
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com. Inclusion Criteria: A. Common to All Indications: * Life expectancy at least 12 weeks * ECOG Performance Status of 0-2 B. For Acute myelogenous leukemia (AML) Subjects: * First Relapse and pri...
BMS-936564 is an investigational therapy studied in acute myelogenous leukemia, as well as selected B-cell cancers including diffuse large B-cell leukemia, chronic lymphocytic leukemia, and follicular lymphoma. It has been evaluated in a single Phase 1 first-in-human clinical trial in adults. It is not an approved treatment.
BMS-936564 targets CXCR4, a chemokine receptor. The compound is described as an anti-CXCR4 antibody, and its first-in-human study was designed to assess safety, tolerability, and preliminary efficacy of CXCR4-directed treatment in patients with acute myelogenous leukemia and selected B-cell cancers.
BMS-936564 is developed by Bristol-Myers Squibb Company, which trades on the New York Stock Exchange under the ticker BMY. The company sponsored the first-in-human Phase 1 study of the compound in patients with acute myelogenous leukemia and selected B-cell cancers.
BMS-936564 is in Phase 1 development. It has been evaluated in one completed Phase 1 first-in-human trial, and no trials are currently active. The drug remains investigational and has not been approved by the FDA for any indication.
BMS-936564 has been studied in one clinical trial, NCT01120457, titled a first-in-human study to determine the safety, tolerability, and preliminary efficacy of an anti-CXCR4 antibody in subjects with acute myelogenous leukemia and selected B-cell cancers. The Phase 1 trial enrolled 96 participants in the United States and is completed.
BMS-936564 is also referred to as BMS-936564 (Anti-CXCR4), reflecting its CXCR4-targeting antibody design. Searches for the anti-CXCR4 antibody studied in acute myelogenous leukemia refer to the same Bristol-Myers Squibb compound. It is a single investigational asset, not a separate drug.