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

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ClinicalTrials.gov Identifier: NCT03783403
Recruitment Status : Recruiting
First Posted : December 21, 2018
Last Update Posted : October 1, 2019
Sponsor:
Information provided by (Responsible Party):
Celgene

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 Intervention/treatment Phase
Neoplasms Drug: CC-95251 Drug: Rituximab Drug: Cetuximab 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.

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Study Type : Interventional  (Clinical Trial)
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 : January 24, 2019
Estimated Primary Completion Date : January 17, 2023
Estimated Study Completion Date : January 17, 2023

Resource links provided by the National Library of Medicine


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 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.

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.




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.



Information from the National Library of Medicine

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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:

  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.

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: Shailaja Uttamsingh 415-839-7053 suttamsingh@celgene.com
Contact: Jennifer Ilagan 415-839-7171 jilagan@celgene.com

Locations
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United States, Alabama
University of Alabama Birmingham Recruiting
Birmingham, Alabama, United States, 35294
United States, Arizona
HonorHealth Research Institute Recruiting
Scottsdale, Arizona, United States, 85258
United States, California
Moores UCSD Cancer Center Not yet recruiting
La Jolla, California, United States, 92093
United States, North Carolina
Levine Cancer Institute Not yet recruiting
Charlotte, North Carolina, United States, 28204
United States, Oklahoma
University of Oklahoma Peggy and Charles Stephenson Cancer Center Recruiting
Oklahoma City, Oklahoma, United States, 73104
United States, Pennsylvania
University of Pittsburgh Medical Center - Cancer Pavilion Recruiting
Pittsburgh, Pennsylvania, United States, 15232
United States, Tennessee
Tennessee Oncology Recruiting
Nashville, Tennessee, United States, 37203
United States, Texas
The University of Texas - MD Anderson Cancer Center Not yet recruiting
Houston, Texas, United States, 77030
South Texas Accelerated Research Therapeutics Recruiting
San Antonio, Texas, United States, 78229
Australia, New South Wales
Chris O'Brien Lifehouse Not yet recruiting
Camperdown, New South Wales, Australia, 2050
Australia, Victoria
Austin Health - Austin Hospital Not yet recruiting
Heidelberg, Victoria, Australia, 3084
Peter MacCallum Cancer Centre Not yet recruiting
Melbourne, Victoria, Australia, 3000
Canada, Alberta
Cross Cancer Institute Recruiting
Edmonton, Alberta, Canada, T6G 1Z2
Canada, Ontario
Princess Margaret Cancer Centre Recruiting
Toronto, Ontario, Canada, M5G 2M9
Sponsors and Collaborators
Celgene
Investigators
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Study Director: Amar Patel, MD Celgene

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Responsible Party: Celgene
ClinicalTrials.gov Identifier: NCT03783403     History of Changes
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: October 1, 2019
Last Verified: September 2019

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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
Antibodies
Immunoglobulins
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents, Immunological
Antineoplastic Agents
Antirheumatic Agents