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The purpose of this study is to identify a safe and tolerable dose of BMS-906024 in subjects with advanced or metastatic solid tumors who no longer respond to or have relapsed from standard therapies.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A1 (Escalation): BMS-906024 | Experimental | BMS-906024 solution intravenously as specified |
|
| Arm A2 (Expansion): BMS-906024 | Experimental | BMS-906024 solution intravenously as specified |
|
| Arm B1 (Escalation): BMS-906024 | Experimental | BMS-906024 solution intravenously as specified |
|
| Arm B2 (Expansion): BMS-906024 | Experimental | BMS-906024 solution intravenously as specified |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-906024 | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of subjects with adverse events as a measure of safety and tolerability | Weekly assessments until study discontinuation due to disease progression or unacceptable adverse event as well as an assessment 30 day after treatment discontinuation with an average time on study expected to be <1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Tumor assessments using response evaluation criteria in solid tumors (RECIST) v1.1 | Tumor assessments at least every 8 weeks during treatment period | |
| PD changes from baseline in the expression of Notch pathway-related genes in surrogate tissues (peripheral blood cells) and tumor biopsies |
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For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anthony El-Khoueiry, Md | Los Angeles | California | 90033 | United States | ||
| Winship Cancer Institute. |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34590610 | Derived | Chan D, Kaplan J, Gordon G, Desai J. Activity of the Gamma Secretase Inhibitor AL101 in Desmoid Tumors: A Case Report of 2 Adult Cases. Curr Oncol. 2021 Sep 21;28(5):3659-3667. doi: 10.3390/curroncol28050312. |
| Label | URL |
|---|---|
| BMS Clinical Trial Patient Recruiting | View source |
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| PD changes from baseline during the first 4-5 weeks of dosing |
| PK parameters for BMS-906024 and its metabolite BMS-911557, maximum observed concentration (Cmax) | PK at multiple time points during the first 8 weeks of dosing |
| PK parameters for BMS-906024 and its metabolite BMS-911557, minimum observed concentration (Cmin) | PK at multiple time points during the first 8 weeks of dosing |
| PK parameters for BMS-906024 and its metabolite BMS-911557, time to reach maximum observed concentration (Tmax) | PK at multiple time points during the first 8 weeks of dosing |
| PK parameters for BMS-906024 and its metabolite BMS-911557, terminal phase elimination half-life (T-Half) | PK at multiple time points during the first 8 weeks of dosing |
| PK parameters for BMS-906024 and its metabolite BMS-911557, accumulation index (AI) | PK at multiple time points during the first 8 weeks of dosing |
| PK parameters for BMS-906024 and its metabolite BMS-911557, area under the concentration-time curve (AUC) | PK at multiple time points during the first 8 weeks of dosing |
| Atlanta |
| Georgia |
| 30322 |
| United States |
| Wayne State University | Detroit | Michigan | 48201 | United States |
| University Of Mississippi Medical Center | Jackson | Mississippi | 39216 | United States |
| Vanderbilt-Ingram Cancer Center | Nashville | Tennessee | 37232 | United States |
| The Methodist Hospital Research Institute | Houston | Texas | 77030 | United States |
| Local Institution | Parkville | Victoria | 3050 | Australia |
| Local Institution | Toronto | Ontario | M5G 2M9 | Canada |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C000606543 | BMS-906024 |
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