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

  • Clinicaltrials.gov identifier

    NCT03783403

  • Recruitment Status

    Recruiting

  • First Posted

    December 21, 2018

  • Last update posted

    August 20, 2021

Study Description

Brief summary:

Study CC-95251-ST-001 is an open-label, Phase 1, dose escalation (Part A) and expansion (Parts B and C), first-in-human clinical study of CC-95251 in subjects with advanced cancers.

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

Detailed Description

Study CC-95251-ST-001 is an open-label, Phase 1, dose escalation (Part A) and expansion (Part B & Part C), first-in-human clinical study of CC-95251 in subjects with advanced solid & hematologic cancers. The dose escalation part (Part A) of the study will be conducted in three stages. Stage 1 will evaluate the safety and tolerability of escalating doses of CC-95251, administered IV, to determine the maximum tolerated dose (MTD), non-tolerated dose (NTD), and/or recommended Phase 2 dose (RP2D) of CC-95251. Stage 2 will evaluate the safety and tolerability of escalating doses of CC-95251 in combination with weekly cetuximab, both administered IV, to determine the MTD, NTD, and/or RP2D of CC-95251 plus cetuximab. Stage 3 will evaluate the safety and tolerability of escalating doses of CC-95251 in combination with rituximab, both administered IV, to establish MTD, NTD, and/or RP2D of CC-95251 plus rituximab.

Study Design

  • Study Type: Interventional
  • Estimated Enrollment: 230 participants
  • 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 SIRPa, Alone and in Combination With Cetuximab or Rituximab in Subjects With Advanced Solid and Hematologic Cancers
  • Actual Study Start Date: February 2019
  • Estimated Primary Completion Date: November 2022
  • Estimated Study Completion Date: November 2024

Arms and interventions

Arm Intervention/treatment
Experimental: CC-95251 alone
CC-95251 administered by IV (intravenous) infusion
Drug: CC-95251
CC-95251 administered by IV (intravenous) infusion.
Experimental: CC-95251 in combination with cetuximab
CC-95251 administered by IV (intravenous) infusion; Cetuximab administered by IV (intravenous) infusion.
Drug: CC-95251
CC-95251 administered by IV (intravenous) infusion.

Drug: Cetuximab
Cetuximab administered by IV (intravenous) infusion.
Experimental: CC-95251 in combination with rituximab
CC-95251 administered by IV (intravenous) infusion; Rituximab administered by IV (intravenous) infusion.
Drug: CC-95251
CC-95251 administered by IV (intravenous) infusion.

Drug: Rituximab
Rituximab administered by IV (intravenous) infusion.

Outcome Measures

  • Primary Outcome Measures: 1. Adverse Event(s) [ Time Frame: From enrollment until at least 56 days after completion of study treatment ]
    Number of subjects with adverse event
  • 2. Non-Tolerated Dose (NTD) [ Time Frame: 18 months ]
    A dose that causes unacceptable side effects.
  • 3. Maximum Tolerated Dose (MTD) [ Time Frame: 18 months ]
    The highest dose that does not cause unacceptable side effects.
  • 4. Dose-Limiting Toxicity (DLT) [ Time Frame: 30 months ]
    Any adverse events meeting the protocol-defined DLT criteria.
  • Secondary Outcome Measures: 1. Overall response rate (ORR) [ Time Frame: 66 Months ]
    The percent of subjects whose best response is CR or PR.
  • 2. Time to response (TTR) [ Time Frame: 66 Months ]
    Time from the first dose to the first objective tumor response observed for patients who achieved a CR or PR.
  • 3. Duration of response (DOR) [ Time Frame: 66 Months ]
    Time from the first objective tumor response observed for patients who achieved a CR or PR until the first date at progressive disease is objectively documented.
  • 4. Progression free survival (PFS) [ Time Frame: 66 Months ]
    Time from the first dose to the first occurrence of disease progression or death from any cause.
  • 5. Overall survival (OS) [ Time Frame: 66 Months ]
    Time from the first dose to death due to any cause.
  • 6. Pharmacokinetic - Cmax [ Time Frame: 36 Months ]
    Maximum serum concentration of the drug
  • 7. Pharmacokinetic - Cmin [ Time Frame: 36 Months ]
    Minimum serum concentration of the drug.
  • 8. Pharmacokinetic - AUC [ Time Frame: 36 Months ]
    Area under the serum concentration time-curve of the drug.
  • 9. Pharmacokinetic - tmax [ Time Frame: 36 Months ]
    Time to peak (maximum) serum concentration of the drug.
  • 10. Pharmacokinetic - t1/2 [ Time Frame: 36 Months ]
    Terminal half-life of the drug.
  • 11. Pharmacokinetic - CL [ Time Frame: 36 Months ]
    Total body clearance of the drug from the serum.
  • 12. Pharmacokinetic - Vss [ Time Frame: 36 Months ]
    Volume of distribution of the drug at steady state.
  • 13. Anti-CC-95251 antibody (ADA) assessment [ Time Frame: 36 Months ]
    Determine the presence and frequency of anti-drug antibodies of the drug.

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: 1. Subject must understand and voluntarily sign an informed consent form (ICF). 2. Subject (male or female) is ≥ 18 years of age at the time of signing the ICF. 3. Subject must have progressed on (or not been able to tolerate due to medical comorbidities or unacceptable toxicity) standard anticancer therapy or for whom no other approved conventional therapy exists and have histological or cytological confirmation of advanced unresectable solid tumors. 4. Subject must have at least one site of measurable disease as determined by RECIST v1.1. NHL subjects must have bi-dimensionally measurable disease on cross sectional imaging by CT or MRI as defined by Lugano/IWG criteria. 5. Subject has an ECOG PS of 0 or 1. 6. Subjects must exhibit acceptable hematopoietic, liver, renal, and coagulation function as assessed by laboratory tests. 7. Subject is willing and able to adhere to the study visit schedule and other protocol requirements. Exclusion Criteria: 1. Subject has received prior investigational therapy directed at CD47 or SIRPα. 2. Subject has cancer with symptomatic central nervous system involvement. 3. Subject is on chronic systemic immunosuppressive therapy or corticosteroids. 4. Subjects with a history of clinically significant cardiac disease within the previous 6 months. 5. Subject had a prior systemic cancer-directed treatments or investigational modalities ≤ 5 half-lives or 4 weeks prior to starting CC-95251, whichever is shorter. 6. Subject had major surgery ≤ 2 weeks prior to starting CC-95251. 7. Subject is a pregnant or lactating female. 8. Subject has known human immunodeficiency virus (HIV) infection. 9. Subject has known chronic, active hepatitis B or C (HBV/HCV) infection. 10. Ongoing treatment with chronic, therapeutic dosing of anti-coagulants. 11. History of autoimmune hemolytic anemia or autoimmune thrombocytopenia. 12. History of concurrent second cancers requiring active, ongoing systemic treatment. 13. For subjects receiving cetuximab, known history of cetuximab intolerance.

Contacts and Locations

Contacts

Contact: Shailaja Uttamsingh 415-839-7053 suttamsingh@celgene.com

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, Colorado
Rocky Mountain Cancer Centers, LLP [Aurora-COAU]
Aurora

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, North Carolina
Levine Cancer Institute
Charlotte

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, Tennessee
Tennessee Oncology
Nashville

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

United States, Texas
US Oncology Research
Irving

United States, Texas
South Texas Accelerated Research Therapeutics
San Antonio

United States, Texas
Texas Oncology - San Antonio Medical Center
San Antonio

Australia, New South Wales
Chris O'Brien Lifehouse
Camperdown

Australia, Victoria
Austin Health - Austin Hospital
Heidelberg

Australia, Victoria
Peter MacCallum Cancer Centre
Melbourne

Canada, Alberta
Cross Cancer Institute
Edmonton

Canada, Ontario
Princess Margaret Cancer Centre
Toronto

Canada, Quebec
McGill University Health Center
Montreal

France
Institut Bergonie
Borddeaux Cedex

France
Hotel Dieu CHU Nantes
Nantes Cedex 01

France
CLCC H BecquerelHematology
Rouen

France
Gustave Roussy
Villejuif CEDEX

Spain
Hospital Universitario Virgen De La Victoria
Malaga

Spain
Universitario de Salamanca - Hospital Clinico
Salamanca

Sponsors and Collaborators

Celgene

Investigators

Study Director: Amar Patel, MD Celgene

More Information

  • Responsible Party: Celgene
  • ClinicalTrials.gov Identifier: NCT03783403 History of Changes
  • Other Study ID Numbers: CC-95251-ST-001, U1111-1224-8251, NCT03816254
  • First Posted: December 21, 2018 Key Record Dates
  • Last Update Posted: August 20, 2021
  • Last Verified: August 2021
  • Studies a U.S. FDA-regulated Drug Product: Yes
  • Studies a U.S. FDA-regulated Device Product: No
  • Keywords provided by Celgene: Advanced Hematologic Cancers
    Advanced Solid Cancers
    SIRPα
    CC-95251
    Antibody
  • Additional relevant MeSH terms: Hematologic Neoplasms