| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1224-8251 | Registry Identifier | WHO |
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Business objectives have changed.
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The purpose of this study is to evaluate the safety, tolerability, and preliminary clinical activity of CC-95251 as a single agent and in combination with cetuximab and rituximab in participants with advanced solid and hematologic cancers.
This is a test.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CC-95251 | Experimental |
| |
| CC-95251 in combination with rituximab | Experimental |
| |
| CC-95251 in combination with cetuximab | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CC-95251 | Drug | Specified dose on specified days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Non-Tolerated Dose (NTD): A dose that causes unacceptable side effects | 18 months | |
| Maximum Tolerated Dose (MTD): The highest dose that does not cause unacceptable side effects | 18 months | |
| Dose-Limiting Toxicity (DLT): Any adverse events meeting the protocol-defined DLT criteria | 30 months |
| Measure | Description | Time Frame |
|---|---|---|
| Overall response rate (ORR): The percent of participants whose best response is complete response (CR) or partial response (PR) | 72 Months | |
| Time to response (TTR): Time from the first dose to the first objective tumor response observed for participants who achieved a CR or PR |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria apply
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution - 105 | Birmingham | Alabama | 35294 | United States | ||
| Local Institution - 101 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38319147 | Derived | Chan H, Trout CV, Mikolon D, Adams P, Guzman R, Mavrommatis K, Abbasian M, Hadjivassiliou H, Dearth L, Fox BA, Sivakumar P, Cho H, Hariharan K. Discovery and Preclinical Activity of BMS-986351, an Antibody to SIRPalpha That Enhances Macrophage-mediated Tumor Phagocytosis When Combined with Opsonizing Antibodies. Cancer Res Commun. 2024 Feb 22;4(2):505-515. doi: 10.1158/2767-9764.CRC-23-0634. |
| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
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| Rituximab | Drug | Specified dose on specified days |
|
| Cetuximab | Drug | Specified dose on specified days |
|
| 66 Months |
| Duration of response (DOR): Time from the first objective tumor response observed for participants who achieved a CR or PR until the first date at progressive disease is objectively documented | 66 Months |
| Progression free survival (PFS): Time from the first dose to the first occurrence of disease progression or death from any cause | 66 Months |
| Overall survival (OS): Time from the first dose to death due to any cause | 66 Months |
| Pharmacokinetic - Maximum serum concentration of the drug (Cmax) | 36 Months |
| Pharmacokinetic - Minimum serum concentration of the drug (Cmin) | 36 Months |
| Pharmacokinetic - Area under the serum concentration time-curve of the drug (AUC) | 36 Months |
| Anti-CC-95251 antibody (ADA) assessment: determine the presence and frequency of anti-drug antibodies | 36 Months |
| Scottsdale |
| Arizona |
| 85258 |
| United States |
| Local Institution - 112 | Sacramento | California | 95817 | United States |
| Rocky Mountain Cancer Centers, LLP [Aurora-COAU] | Aurora | Colorado | 80012 | United States |
| Local Institution - 115 | St Louis | Missouri | 63110 | United States |
| Local Institution - 110 | New York | New York | 10016 | United States |
| Local Institution - 109 | Charlotte | North Carolina | 28204 | United States |
| Local Institution - 106 | Oklahoma City | Oklahoma | 73104 | United States |
| Local Institution - 113 | Portland | Oregon | 97213 | United States |
| Local Institution - 107 | Pittsburgh | Pennsylvania | 15232 | United States |
| Local Institution - 102 | Nashville | Tennessee | 37203-1625 | United States |
| Local Institution - 108 | Houston | Texas | 77030 | United States |
| Local Institution - 103 | San Antonio | Texas | 78229 | United States |
| Local Institution - 301 | Heidelberg | Victoria | 3084 | Australia |
| Local Institution - 303 | Melbourne | Victoria | 3000 | Australia |
| Local Institution - 201 | Edmonton | Alberta | T6G 1Z2 | Canada |
| Local Institution - 202 | Toronto | Ontario | M5G 2M9 | Canada |
| Local Institution - 402 | Borddeaux Cedex | 33076 | France |
| Local Institution - 406 | Créteil | 94010 | France |
| Local Institution - 405 | Marseille | 13009 | France |
| Local Institution - 404 | Nantes | 44093 | France |
| Local Institution - 403 | Rouen | 76038 | France |
| Local Institution - 401 | Villejuif | 94805 | France |
| Local Institution - 604 | Seoul | 03722 | South Korea |
| Local Institution - 603 | Seoul | 06351 | South Korea |
| Local Institution - 602 | Seoul | 3080 | South Korea |
| Local Institution - 601 | Seoul | 5505 | South Korea |
| Local Institution - 504 | Madrid | 28040 | Spain |
| Local Institution - 502 | Málaga | 29010 | Spain |
| Local Institution - 501 | Salamanca | 37007 | Spain |
| Local Institution - 802 | Manchester | M20 4BX | United Kingdom |
| BMS Clinical Trial Patient Recruiting | View source |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D000069283 | Rituximab |
| D000068818 | Cetuximab |
| ID | Term |
|---|---|
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D061067 | Antibodies, Monoclonal, Humanized |
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