Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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 small molecule being studied for the treatment of Acute Myelogenous Leukemia (AML). It is also being evaluated in selected B-cell cancers, including Diffuse Large B-Cell Leukemia, Chronic Lymphocytic Leukemia, and Follicular Lymphoma, as part of a Phase 1 clinical trial.
BMS-936564 is an anti-CXCR4 antibody. It targets the CXCR4 receptor, which is involved in cell signaling and migration. By binding to CXCR4, the drug aims to interfere with cancer cell survival and trafficking, potentially enhancing the effects of other treatments in hematologic malignancies.
BMS-936564 is being developed by Bristol-Myers Squibb Company, a global biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol BMY. The company is conducting clinical research to evaluate the safety and efficacy of this investigational agent.
BMS-936564 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. The Phase 1 trial is designed to assess the safety, tolerability, and preliminary efficacy of the drug in patients with Acute Myelogenous Leukemia and selected B-cell cancers.
BMS-936564 is being studied in a single completed Phase 1 clinical trial with the identifier NCT01120457. The trial enrolled 96 participants in the United States and was a controlled, open-label study. It evaluated the drug in patients with Acute Myelogenous Leukemia, Diffuse Large B-Cell Leukemia, Chronic Lymphocytic Leukemia, and Follicular Lymphoma.
Yes, BMS-936564 is an anti-CXCR4 antibody. It is designed to target the CXCR4 receptor, which is expressed on certain cancer cells. The drug is being investigated for its potential role in treating hematologic malignancies, including Acute Myelogenous Leukemia and other B-cell cancers.