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

August 6, 2024 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

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This is a test.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
230

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Celgene

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2019

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 16, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 23, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 19, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 19, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 21, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 9, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 6, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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