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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
206
Non-Tolerated Dose (NTD): A dose that causes unacceptable side effects
Time frame: 18 months
Maximum Tolerated Dose (MTD): The highest dose that does not cause unacceptable side effects
Time frame: 18 months
Dose-Limiting Toxicity (DLT): Any adverse events meeting the protocol-defined DLT criteria
Time frame: 30 months
Overall response rate (ORR): The percent of participants whose best response is complete response (CR) or partial response (PR)
Time frame: 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
Time frame: 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
Time frame: 66 Months
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
Overall survival (OS): Time from the first dose to death due to any cause
Time frame: 66 Months
Pharmacokinetic - Maximum serum concentration of the drug (Cmax)
Time frame: 36 Months
Pharmacokinetic - Minimum serum concentration of the drug (Cmin)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Local Institution - 105
Birmingham, Alabama, United States
Local Institution - 101
Scottsdale, Arizona, United States
Local Institution - 112
Sacramento, California, United States
Rocky Mountain Cancer Centers, LLP [Aurora-COAU]
Aurora, Colorado, United States
Local Institution - 115
St Louis, Missouri, United States
Local Institution - 110
New York, New York, United States
Local Institution - 109
Charlotte, North Carolina, United States
Local Institution - 106
Oklahoma City, Oklahoma, United States
Local Institution - 113
Portland, Oregon, United States
Local Institution - 107
Pittsburgh, Pennsylvania, United States
...and 21 more locations
Time frame: 36 Months
Pharmacokinetic - Area under the serum concentration time-curve of the drug (AUC)
Time frame: 36 Months
Anti-CC-95251 antibody (ADA) assessment: determine the presence and frequency of anti-drug antibodies
Time frame: 36 Months