Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03783403
Recruitment Status : Recruiting
First Posted : December 21, 2018
Last Update Posted : October 25, 2021
Sponsor:
Information provided by (Responsible Party):
Celgene

Tracking Information
First Submitted Date  ICMJE December 19, 2018
First Posted Date  ICMJE December 21, 2018
Last Update Posted Date October 25, 2021
Actual Study Start Date  ICMJE February 1, 2019
Estimated Primary Completion Date November 8, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 19, 2018)
  • Adverse Event(s) [ Time Frame: From enrollment until at least 56 days after completion of study treatment ]
    Number of subjects with adverse event
  • Non-Tolerated Dose (NTD) [ Time Frame: 18 months ]
    A dose that causes unacceptable side effects.
  • Maximum Tolerated Dose (MTD) [ Time Frame: 18 months ]
    The highest dose that does not cause unacceptable side effects.
  • Dose-Limiting Toxicity (DLT) [ Time Frame: 30 months ]
    Any adverse events meeting the protocol-defined DLT criteria.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 23, 2019)
  • Overall response rate (ORR) [ Time Frame: 66 Months ]
    The percent of subjects whose best response is CR or PR.
  • 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.
  • 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.
  • 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.
  • Overall survival (OS) [ Time Frame: 66 Months ]
    Time from the first dose to death due to any cause.
  • Pharmacokinetic - Cmax [ Time Frame: 36 Months ]
    Maximum serum concentration of the drug
  • Pharmacokinetic - Cmin [ Time Frame: 36 Months ]
    Minimum serum concentration of the drug.
  • Pharmacokinetic - AUC [ Time Frame: 36 Months ]
    Area under the serum concentration time-curve of the drug.
  • Pharmacokinetic - tmax [ Time Frame: 36 Months ]
    Time to peak (maximum) serum concentration of the drug.
  • Pharmacokinetic - t1/2 [ Time Frame: 36 Months ]
    Terminal half-life of the drug.
  • Pharmacokinetic - CL [ Time Frame: 36 Months ]
    Total body clearance of the drug from the serum.
  • Pharmacokinetic - Vss [ Time Frame: 36 Months ]
    Volume of distribution of the drug at steady state.
  • Anti-CC-95251 antibody (ADA) assessment [ Time Frame: 36 Months ]
    Determine the presence and frequency of anti-drug antibodies of the drug.
Original Secondary Outcome Measures  ICMJE
 (submitted: December 19, 2018)
  • Overall response rate (ORR) [ Time Frame: 42 Months ]
    The percent of subjects whose best response is CR or PR.
  • Time to response (TTR) [ Time Frame: 42 Months ]
    Time from the first dose to the first objective tumor response observed for patients who achieved a CR or PR.
  • Duration of response (DOR) [ Time Frame: 42 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.
  • Progression free survival (PFS) [ Time Frame: 42 Months ]
    Time from the first dose to the first occurrence of disease progression or death from any cause.
  • Overall survival (OS) [ Time Frame: 42 Months ]
    Time from the first dose to death due to any cause.
  • Pharmacokinetic - Cmax [ Time Frame: 30 Months ]
    Maximum serum concentration of the drug
  • Pharmacokinetic - Cmin [ Time Frame: 30 Months ]
    Minimum serum concentration of the drug.
  • Pharmacokinetic - AUC [ Time Frame: 30 Months ]
    Area under the serum concentration time-curve of the drug.
  • Pharmacokinetic - tmax [ Time Frame: 30 Months ]
    Time to peak (maximum) serum concentration of the drug.
  • Pharmacokinetic - t1/2 [ Time Frame: 30 Months ]
    Terminal half-life of the drug.
  • Pharmacokinetic - CL [ Time Frame: 30 Months ]
    Total body clearance of the drug from the serum.
  • Pharmacokinetic - Vss [ Time Frame: 30 Months ]
    Volume of distribution of the drug at steady state.
  • Anti-CC-95251 antibody (ADA) assessment [ Time Frame: 30 Months ]
    Determine the presence and frequency of anti-drug antibodies of the drug.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of CC-95251, a Monoclonal Antibody Directed Against SIRPα, in Subjects With Advanced Solid and Hematologic Cancers
Official Title  ICMJE 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
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Neoplasms
Intervention  ICMJE
  • Drug: CC-95251
    CC-95251 administered by IV (intravenous) infusion.
  • Drug: Rituximab
    Rituximab administered by IV (intravenous) infusion.
  • Drug: Cetuximab
    Cetuximab administered by IV (intravenous) infusion.
Study Arms  ICMJE
  • Experimental: CC-95251 alone
    CC-95251 administered by IV (intravenous) infusion
    Intervention: Drug: CC-95251
  • Experimental: CC-95251 in combination with rituximab
    CC-95251 administered by IV (intravenous) infusion; Rituximab administered by IV (intravenous) infusion.
    Interventions:
    • Drug: CC-95251
    • Drug: Rituximab
  • Experimental: CC-95251 in combination with cetuximab
    CC-95251 administered by IV (intravenous) infusion; Cetuximab administered by IV (intravenous) infusion.
    Interventions:
    • Drug: CC-95251
    • Drug: Cetuximab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 6, 2019)
230
Original Estimated Enrollment  ICMJE
 (submitted: December 19, 2018)
140
Estimated Study Completion Date  ICMJE November 7, 2024
Estimated Primary Completion Date November 8, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Shailaja Uttamsingh 415-839-7053 suttamsingh@celgene.com
Listed Location Countries  ICMJE Australia,   Canada,   France,   Italy,   Korea, Republic of,   Spain,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03783403
Other Study ID Numbers  ICMJE CC-95251-ST-001
U1111-1224-8251 ( Registry Identifier: WHO )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Celgene
Study Sponsor  ICMJE Celgene
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Amar Patel, MD Celgene
PRS Account Celgene
Verification Date October 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP