A Study of CC-95251, a Monoclonal Antibody Directed Against SIRPα, in Participants With Advanced Solid and Hematologic Cancers
- Conditions
- Neoplasms
- Interventions
- Registration Number
- NCT03783403
- Lead Sponsor
- Celgene
- 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.
- Detailed Description
This is a test.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 230
- Progressed on standard anticancer therapy or for whom no other approved conventional therapy exists and have histological or cytological confirmation of advanced unresectable solid tumors, advanced unresectable colorectal cancer, or squamous cell carcinoma of the head and neck, or CD20-positive non-Hodgkin's lymphoma, or diffuse large B cell lymphoma, or follicular lymphoma
- Solid tumors must have at least one site of measurable disease as determined by RECIST v1.1
- Eastern cooperative oncology group performance status of 0 or 1
- High-grade lymphomas (Burkitt's or lymphoblastic)
- Has cancer with symptomatic central nervous system (CNS) involvement
- History of class III or IV congestive heart failure (CHF) or severe non-ischemic cardiomyopathy, unstable angina, myocardial infarction, or ventricular arrhythmia within the previous 6 months
Other protocol-defined inclusion/exclusion criteria apply
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description CC-95251 CC-95251 - CC-95251 in combination with rituximab CC-95251 - CC-95251 in combination with cetuximab CC-95251 - CC-95251 in combination with rituximab Rituximab - CC-95251 in combination with cetuximab Cetuximab -
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method Overall response rate (ORR): The percent of participants whose best response is complete response (CR) or partial response (PR) 72 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 Time to response (TTR): Time from the first dose to the first objective tumor response observed for participants who achieved a CR or PR 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 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
Trial Locations
- Locations (31)
Local Institution - 107
🇺🇸Pittsburgh, Pennsylvania, United States
Local Institution - 108
🇺🇸Houston, Texas, United States
Local Institution - 103
🇺🇸San Antonio, Texas, United States
Local Institution - 105
🇺🇸Birmingham, Alabama, United States
Rocky Mountain Cancer Centers, LLP [Aurora-COAU]
🇺🇸Aurora, Colorado, United States
Local Institution - 109
🇺🇸Charlotte, North Carolina, United States
Local Institution - 113
🇺🇸Portland, Oregon, United States
Local Institution - 406
🇫🇷Creteil, France
Local Institution - 405
🇫🇷Marseille, France
Local Institution - 202
🇨🇦Toronto, Ontario, Canada
Local Institution - 303
🇦🇺Melbourne, Victoria, Australia
Local Institution - 604
🇰🇷Seoul, Korea, Republic of
Local Institution - 504
🇪🇸Madrid, Spain
Local Institution - 501
🇪🇸Salamanca, Spain
Local Institution - 110
🇺🇸New York, New York, United States
Local Institution - 101
🇺🇸Scottsdale, Arizona, United States
Local Institution - 401
🇫🇷Villejuif CEDEX, France
Local Institution - 115
🇺🇸Saint Louis, Missouri, United States
Local Institution - 602
🇰🇷Seoul, Korea, Republic of
Local Institution - 402
🇫🇷Borddeaux Cedex, France
Local Institution - 502
🇪🇸Malaga, Spain
Local Institution - 603
🇰🇷Seoul, Korea, Republic of
Local Institution - 601
🇰🇷Seoul, Korea, Republic of
Local Institution - 201
🇨🇦Edmonton, Alberta, Canada
Local Institution - 301
🇦🇺Heidelberg, Victoria, Australia
Local Institution - 106
🇺🇸Oklahoma City, Oklahoma, United States
Local Institution - 102
🇺🇸Nashville, Tennessee, United States
Local Institution - 404
🇫🇷Nantes Cedex 01, France
Local Institution - 403
🇫🇷Rouen, France
Local Institution - 802
🇬🇧Manchester, United Kingdom
Local Institution - 112
🇺🇸Sacramento, California, United States