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A Study of CC-95251, a Monoclonal Antibody Directed Against SIRPα, in Participants With Advanced Solid and Hematologic Cancers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03783403
Recruitment Status : Recruiting
First Posted : December 21, 2018
Last Update Posted : February 17, 2023
Sponsor:
Information provided by (Responsible Party):
Celgene

Study Description
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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 Intervention/treatment Phase
Neoplasms Drug: CC-95251 Drug: Rituximab Drug: Cetuximab Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 230 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1, Open-label, Dose Finding Study of CC-95251, a Monoclonal Antibody Directed Against SIRPα, Alone and in Combination With Cetuximab or Rituximab in Subjects With Advanced Solid and Hematologic Cancers
Actual Study Start Date : February 1, 2019
Estimated Primary Completion Date : June 20, 2024
Estimated Study Completion Date : August 25, 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: CC-95251 Drug: CC-95251
Specified dose on specified days
Experimental: CC-95251 in combination with rituximab Drug: CC-95251
Specified dose on specified days

Drug: Rituximab
Specified dose on specified days
Experimental: CC-95251 in combination with cetuximab Drug: CC-95251
Specified dose on specified days

Drug: Cetuximab
Specified dose on specified days


Outcome Measures
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Primary Outcome Measures :
  1. Non-Tolerated Dose (NTD): A dose that causes unacceptable side effects [ Time Frame: 18 months ]
  2. Maximum Tolerated Dose (MTD): The highest dose that does not cause unacceptable side effects [ Time Frame: 18 months ]
  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 ]
  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 ]
  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 ]
  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 ]
  5. Overall survival (OS): Time from the first dose to death due to any cause [ Time Frame: 66 Months ]
  6. Pharmacokinetic - Maximum serum concentration of the drug (Cmax) [ Time Frame: 36 Months ]
  7. Pharmacokinetic - Minimum serum concentration of the drug (Cmin) [ Time Frame: 36 Months ]
  8. Pharmacokinetic - Area under the serum concentration time-curve of the drug (AUC) [ Time Frame: 36 Months ]
  9. Anti-CC-95251 antibody (ADA) assessment: determine the presence and frequency of anti-drug antibodies [ Time Frame: 36 Months ]

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

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03783403


Contacts
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Contact: BMS Study Connect Contact Center www.BMSStudyConnect.com 855-907-3286 Clinical.Trials@bms.com
Contact: First line of the email MUST contain the NCT# and Site #.

Locations
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Sponsors and Collaborators
Celgene
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
More Information
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Additional Information:

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Responsible Party: Celgene
ClinicalTrials.gov Identifier: NCT03783403    
Obsolete Identifiers: NCT03816254
Other Study ID Numbers: CC-95251-ST-001
U1111-1224-8251 ( Registry Identifier: WHO )
First Posted: December 21, 2018    Key Record Dates
Last Update Posted: February 17, 2023
Last Verified: February 2023

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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:
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Hematologic Neoplasms
Neoplasms by Site
Neoplasms
Hematologic Diseases
Rituximab
Cetuximab
 Antineoplastic Agents, Immunological
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents