Study Description

Brief summary:

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.

• Condition or Disease:Neoplasms
• Intervention/Treatment: Drug: CC-95251
  Drug: Rituximab
  Drug: Cetuximab
• Phase: Phase 1

Detailed Description

N/A

Study Design

Arms and interventions

Outcome Measures

• Primary Outcome Measures: 1. Non-Tolerated Dose (NTD): A dose that causes unacceptable side effects [ Time Frame: 18 months ]
  
• Primary Outcome Measures: 2. Maximum Tolerated Dose (MTD): The highest dose that does not cause unacceptable side effects [ Time Frame: 18 months ]
  
• Primary Outcome Measures: 3. Dose-Limiting Toxicity (DLT): Any adverse events meeting the protocol-defined DLT criteria [ Time Frame: 30 months ]
  
• Secondary Outcome Measures: 1. Overall response rate (ORR): The percent of participants whose best response is complete response (CR) or partial response (PR) [ Time Frame: 72 Months ]
  
• Secondary Outcome Measures: 2. Time to response (TTR): Time from the first dose to the first objective tumor response observed for participants who achieved a CR or PR [ Time Frame: 66 Months ]
  
• Secondary Outcome Measures: 3. 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 [ Time Frame: 66 Months ]
  
• Secondary Outcome Measures: 4. Progression free survival (PFS): Time from the first dose to the first occurrence of disease progression or death from any cause [ Time Frame: 66 Months ]
  
• Secondary Outcome Measures: 5. Overall survival (OS): Time from the first dose to death due to any cause [ Time Frame: 66 Months ]
  
• Secondary Outcome Measures: 6. Pharmacokinetic - Maximum serum concentration of the drug (Cmax) [ Time Frame: 36 Months ]
  
• Secondary Outcome Measures: 7. Pharmacokinetic - Minimum serum concentration of the drug (Cmin) [ Time Frame: 36 Months ]
  
• Secondary Outcome Measures: 8. Pharmacokinetic - Area under the serum concentration time-curve of the drug (AUC) [ Time Frame: 36 Months ]
  
• Secondary Outcome Measures: 9. Anti-CC-95251 antibody (ADA) assessment: determine the presence and frequency of anti-drug antibodies [ Time Frame: 36 Months ]
  

Eligibility Criteria

Information from the National Library of Medicine

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• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

More Information

• Responsible Party: Celgene
• ClinicalTrials.gov Identifier: NCT03783403 History of Changes
• Other Study ID Numbers: CC-95251-ST-001, NCT03816254, U1111-1224-8251
• First Posted: December 21, 2018 Key Record Dates
• Last Update Posted: June 16, 2022
• Last Verified: June 2022
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Celgene: Antibody
  CC-95251
  SIRPα Advanced Solid Cancers
  Advanced Hematologic Cancers
• Additional relevant MeSH terms: Hematologic Neoplasms
  Neoplasms by Site Neoplasms
  Hematologic Diseases