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

November 30, 2023 updated by: Celgene

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

230

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Victoria
      • Heidelberg, Victoria, Australia, 3084
        • Local Institution - 301
      • Melbourne, Victoria, Australia, 3000
        • Local Institution - 303
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 1Z2
        • Local Institution - 201
    • Ontario
      • Toronto, Ontario, Canada, M5G 2M9
        • Local Institution - 202
  • France
      • Borddeaux Cedex, France, 33076
        • Local Institution - 402
      • Creteil, France, 94010
        • Local Institution - 406
      • Marseille, France, 13009
        • Local Institution - 405
      • Nantes Cedex 01, France, 44093
        • Local Institution - 404
      • Rouen, France, 76038
        • Local Institution - 403
      • Villejuif CEDEX, France, 94805
        • Local Institution - 401
  • Italy
      • Bologna, Italy, 40138
        • Local Institution - 701
      • Napoli, Campania, Italy, 80131
        • Local Institution - 702
  • Korea, Republic of
      • Seoul, Korea, Republic of, 03722
        • Local Institution - 604
      • Seoul, Korea, Republic of, 06351
        • Local Institution - 603
      • Seoul, Korea, Republic of, 3080
        • Local Institution - 602
      • Seoul, Korea, Republic of, 5505
        • Local Institution - 601
  • Spain
      • Madrid, Spain, 28040
        • Local Institution - 504
      • Malaga, Spain, 29010
        • Local Institution - 502
      • Salamanca, Spain, 37007
        • Local Institution - 501
  • United Kingdom
      • Manchester, United Kingdom, M20 4BX
        • Local Institution - 802
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • Local Institution - 105
    • Arizona
      • Scottsdale, Arizona, United States, 85258
        • Local Institution - 101
    • California
      • Sacramento, California, United States, 95817
        • Local Institution - 112
    • Colorado
      • Aurora, Colorado, United States, 80012
        • Rocky Mountain Cancer Centers, LLP [Aurora-COAU]
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Local Institution - 115
    • New York
      • New York, New York, United States, 10016
        • Local Institution - 110
    • North Carolina
      • Charlotte, North Carolina, United States, 28204
        • Local Institution - 109
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Local Institution - 106
    • Oregon
      • Portland, Oregon, United States, 97213
        • Local Institution - 113
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15232
        • Local Institution - 107
    • Tennessee
      • Nashville, Tennessee, United States, 37203-1625
        • Local Institution - 102
    • Texas
      • Houston, Texas, United States, 77030
        • Local Institution - 108
      • San Antonio, Texas, United States, 78229
        • Local Institution - 103

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Non-Tolerated Dose (NTD): A dose that causes unacceptable side effects
Time Frame: 18 months
18 months
Maximum Tolerated Dose (MTD): The highest dose that does not cause unacceptable side effects
Time Frame: 18 months
18 months
Dose-Limiting Toxicity (DLT): Any adverse events meeting the protocol-defined DLT criteria
Time Frame: 30 months
30 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall response rate (ORR): The percent of participants whose best response is complete response (CR) or partial response (PR)
Time Frame: 72 Months
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
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
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
66 Months
Overall survival (OS): Time from the first dose to death due to any cause
Time Frame: 66 Months
66 Months
Pharmacokinetic - Maximum serum concentration of the drug (Cmax)
Time Frame: 36 Months
36 Months
Pharmacokinetic - Minimum serum concentration of the drug (Cmin)
Time Frame: 36 Months
36 Months
Pharmacokinetic - Area under the serum concentration time-curve of the drug (AUC)
Time Frame: 36 Months
36 Months
Anti-CC-95251 antibody (ADA) assessment: determine the presence and frequency of anti-drug antibodies
Time Frame: 36 Months
36 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Celgene

Investigators

  • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2019

Primary Completion (Estimated)

June 20, 2024

Study Completion (Estimated)

August 23, 2024

Study Registration Dates

First Submitted

December 19, 2018

First Submitted That Met QC Criteria

December 19, 2018

First Posted (Actual)

December 21, 2018

Study Record Updates

Last Update Posted (Estimated)

December 1, 2023

Last Update Submitted That Met QC Criteria

November 30, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CC-95251-ST-001
  • U1111-1224-8251 (Registry Identifier: WHO)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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