Clinical Trials /

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

NCT03783403

Description:

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.

Related Conditions:
  • Hematopoietic and Lymphoid Malignancy
  • Malignant Solid Tumor
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

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

Clinical Trial IDs

  • ORG STUDY ID: CC-95251-ST-001
  • SECONDARY ID: U1111-1224-8251
  • NCT ID: NCT03783403
  • NCT ALIAS: NCT03816254

Conditions

  • Neoplasms

Interventions

DrugSynonymsArms
CC-95251CC-95251 alone
RituximabCC-95251 in combination with rituximab
CetuximabCC-95251 in combination with cetuximab

Purpose

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.
    

Trial Arms

NameTypeDescriptionInterventions
CC-95251 aloneExperimentalCC-95251 administered by IV (intravenous) infusion
  • CC-95251
CC-95251 in combination with rituximabExperimentalCC-95251 administered by IV (intravenous) infusion; Rituximab administered by IV (intravenous) infusion.
  • CC-95251
  • Rituximab
CC-95251 in combination with cetuximabExperimentalCC-95251 administered by IV (intravenous) infusion; Cetuximab administered by IV (intravenous) infusion.
  • CC-95251
  • Cetuximab

Eligibility 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.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Adverse Event(s)
Time Frame:From enrollment until at least 56 days after completion of study treatment
Safety Issue:
Description:Number of subjects with adverse event

Secondary Outcome Measures

Measure:Overall response rate (ORR)
Time Frame:66 Months
Safety Issue:
Description:The percent of subjects whose best response is CR or PR.
Measure:Time to response (TTR)
Time Frame:66 Months
Safety Issue:
Description:Time from the first dose to the first objective tumor response observed for patients who achieved a CR or PR.
Measure:Duration of response (DOR)
Time Frame:66 Months
Safety Issue:
Description: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.
Measure:Progression free survival (PFS)
Time Frame:66 Months
Safety Issue:
Description:Time from the first dose to the first occurrence of disease progression or death from any cause.
Measure:Overall survival (OS)
Time Frame:66 Months
Safety Issue:
Description:Time from the first dose to death due to any cause.
Measure:Pharmacokinetic - Cmax
Time Frame:36 Months
Safety Issue:
Description:Maximum serum concentration of the drug
Measure:Pharmacokinetic - Cmin
Time Frame:36 Months
Safety Issue:
Description:Minimum serum concentration of the drug.
Measure:Pharmacokinetic - AUC
Time Frame:36 Months
Safety Issue:
Description:Area under the serum concentration time-curve of the drug.
Measure:Pharmacokinetic - tmax
Time Frame:36 Months
Safety Issue:
Description:Time to peak (maximum) serum concentration of the drug.
Measure:Pharmacokinetic - t1/2
Time Frame:36 Months
Safety Issue:
Description:Terminal half-life of the drug.
Measure:Pharmacokinetic - CL
Time Frame:36 Months
Safety Issue:
Description:Total body clearance of the drug from the serum.
Measure:Pharmacokinetic - Vss
Time Frame:36 Months
Safety Issue:
Description:Volume of distribution of the drug at steady state.
Measure:Anti-CC-95251 antibody (ADA) assessment
Time Frame:36 Months
Safety Issue:
Description:Determine the presence and frequency of anti-drug antibodies of the drug.

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Celgene

Trial Keywords

  • Antibody
  • CC-95251
  • SIRPα
  • Advanced Solid Cancers
  • Advanced Hematologic Cancers

Last Updated

September 29, 2019