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

  • Clinicaltrials.gov identifier

    NCT03783403

  • Recruitment Status

    Recruiting

  • First Posted

    December 21, 2018

  • Last update posted

    June 16, 2022

Study Description

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:Neoplasms
  • Intervention/Treatment: Drug: CC-95251
    Drug: Rituximab
    Drug: Cetuximab
  • Phase: Phase 1

Detailed Description

N/A

Study Design

  • Study Type: Interventional
  • Estimated Enrollment: 230 participants
  • Intervention Model: Single Group Assignment
  • Masking: None (Open Label) ()
  • Primary Purpose: Treatment
  • Official Title: A Study of CC-95251, a Monoclonal Antibody Directed Against SIRPα, in Participants With Advanced Solid and Hematologic Cancers
  • Actual Study Start Date: February 2019
  • Estimated Primary Completion Date: June 2024
  • Estimated Study Completion Date: August 2025

Arms and interventions

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

Drug: Rituximab
Specified dose on specified days

Outcome Measures

  • 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

  • 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

Contacts

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

United States, Alabama
University of Alabama Birmingham
Birmingham

United States, Arizona
HonorHealth Research Institute
Scottsdale

United States, California
UC Davis Medical Center
Sacramento

United States, California
UC Davis Medical Center
Sacramento

United States, Missouri
Washington University School of Medicine
Saint Louis

United States, Missouri
Washington University School Of Medicine
Saint Louis

United States, New York
NYU Langone Laura and Isaac Perlmutter Cancer Center
New York

United States, New York
NYU Langone Laura and Isaac Perlmutter Cancer Center
New York

United States, North Carolina
Levine Cancer Institute
Charlotte

United States, Oklahoma
University of Oklahoma Peggy and Charles Stephenson Cancer Center
Oklahoma City

United States, Oklahoma
University of Oklahoma Peggy and Charles Stephenson Cancer Center
Oklahoma City

United States, Oregon
Providence Cancer Center/Earle A. Chiles Res. Inst.
Portland

United States, Pennsylvania
University of Pittsburgh Medical Center - Cancer Pavilion
Pittsburgh

United States, Pennsylvania
University of Pittsburgh Medical Center - Cancer Pavilion
Pittsburgh

United States, Tennessee
Tennessee Oncology
Nashville

United States, Tennessee
Tennessee Oncology
Nashville

United States, Texas
The University of Texas - MD Anderson Cancer Center
Houston

United States, Texas
The University of Texas - MD Anderson Cancer Center
Houston

United States, Texas
South Texas Accelerated Research Therapeutics
San Antonio

United States, Texas
South Texas Accelerated Research Therapeutics
San Antonio

Australia, Victoria
Austin Health - Austin Hospital
Heidelberg

Australia, Victoria
Local Institution - 301
Heidelberg

Australia, Victoria
Peter MacCallum Cancer Centre
Melbourne

Canada, Alberta
Cross Cancer Institute
Edmonton

Canada, Alberta
Local Institution - 201
Edmonton

Canada, Ontario
Princess Margaret Cancer Centre
Toronto

France
Institut Bergonie
Borddeaux Cedex

France
Local Institution - 402
Borddeaux Cedex

France
Hôpital Henri Mondor
Creteil

France
Local Institution - 406
Creteil

France
Unité Lymphoïde - Hématologie 4-IPC4
Marseille

France
Hotel Dieu CHU Nantes
Nantes Cedex 01

France
Local Institution - 404
Nantes Cedex 01

France
CLCC H BecquerelHematology
Rouen

France
Local Institution - 403
Rouen

France
Gustave Roussy
Villejuif CEDEX

France
Local Institution - 401
Villejuif CEDEX

Italy
Istituto di Ematologia L. e A. Seragnoli-Azienda Ospedaliero Universitaria Policlinico S. Orsola M
Bologna

Italy
Istituto Nazionale Per Lo Studio E La Cura Dei Tumori Fondazione Giovanni Pascale
Napoli, Campania

Korea, Republic of
Local Institution - 604
Seoul

Korea, Republic of
Severance Hospital
Seoul

Korea, Republic of
Samsung Medical Center
Seoul

Korea, Republic of
Local Institution - 602
Seoul

Korea, Republic of
Seoul National University Hospital
Seoul

Korea, Republic of
Asan Medical Center
Seoul

Korea, Republic of
Local Institution - 601
Seoul

Spain
Hospital Universitario Fundacion Jimenez Diaz
Madrid

Spain
Hospital Universitario Virgen De La Victoria
Malaga

Spain
Local Institution - 502
Malaga

Spain
Local Institution - 501
Salamanca

Spain
Universitario de Salamanca - Hospital Clinico
Salamanca

United Kingdom
Derriford Hospital, University Hospitals Plymouth NHS Trust
Crownhill, Plymouth

United Kingdom
Royal Marsden Hospital
London

United Kingdom
Christie NHS Trust
Manchester

Sponsors and Collaborators

Celgene

Investigators

Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

More Information

  • Responsible Party: Celgene
  • ClinicalTrials.gov Identifier: NCT03783403 History of Changes
  • Other Study ID Numbers: CC-95251-ST-001, NCT03816254, U1111-1224-8251
  • First Posted: December 21, 2018 Key Record Dates
  • Last Update Posted: June 16, 2022
  • Last Verified: June 2022
  • 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: Neoplasms
    Hematologic Neoplasms
    Neoplasms by Site
    Hematologic Diseases