Clinical Trials /

Study of CPI-444 as a Single Agent and in Combination With Daratumumab in Patients With Relapsed or Refractory Multiple Myeloma

NCT04280328

Description:

This is a Phase 1b open-label study of CPI-444, an oral, small molecule inhibitor targeting adenosine-2A receptors (A2AR), on safety/tolerability and efficacy as a single agent and in combination with daratumumab, a monoclonal antibody targeting CD38, in relapsed or refractory multiple myeloma.

Related Conditions:
  • Multiple Myeloma
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: Study of CPI-444 as a Single Agent and in Combination With Daratumumab in Patients With Relapsed or Refractory Multiple Myeloma
  • Official Title: A Phase 1b, Open-Label Study of CPI-444 as a Single Agent and in Combination With Daratumumab in Patients With Relapsed or Refractory Multiple Myeloma

Clinical Trial IDs

  • ORG STUDY ID: CPI-444-003
  • NCT ID: NCT04280328

Conditions

  • Multiple Myeloma

Interventions

DrugSynonymsArms
CPI-444ciforadenantCPI-444 single agent / daratumumab add-on
daratumumabCPI-444 single agent / daratumumab add-on

Purpose

This is a Phase 1b open-label study of CPI-444, an oral, small molecule inhibitor targeting adenosine-2A receptors (A2AR), on safety/tolerability and efficacy as a single agent and in combination with daratumumab, a monoclonal antibody targeting CD38, in relapsed or refractory multiple myeloma.

Trial Arms

NameTypeDescriptionInterventions
CPI-444 single agent / daratumumab add-onExperimentalSingle agent CPI-444 100 mg orally twice daily initially. If progressive disease at any time or certain response criteria are not met at specified time-points on single agent treatment, then add on daratumumab IV 16 mg/kg.
  • CPI-444
  • daratumumab

Eligibility Criteria

        Inclusion Criteria:

          -  Relapsed or refractory myeloma.

          -  Must have been exposed to 2 cycles of an IMiD containing regimen and PI containing
             regimen and must be refractory to at least one of the two.

          -  Must have completed and tolerated 2 cycles of daratumumab or other anti-CD38 targeting
             antibodies.

          -  Active myeloma requiring systemic treatment.

          -  Measurable disease per protocol.

          -  ECOG performance status of 0 - 2.

          -  Life expectancy of at least 3 months.

        Exclusion Criteria:

          -  POEMS syndrome; non-secretory myeloma (no measurable protein on sFLC assay);
             amyloidosis.

          -  History of select prior malignancies.

          -  Previous intolerance to daratumumab or any study drug.

          -  Received an allogeneic stem cell transplant within 12 months, or an autologous stem
             cell transplant within 6 months, or have ongoing toxicity related to transplant.

          -  Have an active infection or serious comorbid medical condition.

          -  Any live attenuated vaccination against infectious diseases (e.g., influenza,
             varicella) within 4 weeks of initiation of study treatment; uncontrolled human
             immunodeficiency virus, or positive tests for hepatitis B or hepatitis C.

          -  Female participants pregnant or breast-feeding.

          -  Screening chemistry and blood counts within protocol limits

          -  Treatment with systemic immunosuppressive medication within 2 weeks prior to
             initiation of study treatment or anticipation of need for systemic immunosuppressant
             medication during study treatment.
      
Maximum Eligible Age:80 Years
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Safety and tolerability of single agent CPI-444 in relapsed / refractory multiple myeloma.
Time Frame:From start of treatment to end of treatment, up to 24 months
Safety Issue:
Description:Incidence of treatment-emergent adverse events, as assessed by NCI CTCAE v.5, of CPI-444 as a single agent

Secondary Outcome Measures

Measure:Overall response rate.
Time Frame:From start of treatment to end of treatment, up to 24 months
Safety Issue:
Description:According to international myeloma working group guidelines (including stringent complete response [sCR], complete response [CR], very good partial response [VGPR], partial response [PR]).
Measure:Duration of response.
Time Frame:From start of treatment to end of treatment, up to 24 months
Safety Issue:
Description:Time from the first assessment showing objective response to the date of documented disease progression.
Measure:Disease control rate.
Time Frame:From start of treatment to end of treatment, up to 24 months
Safety Issue:
Description:Proportion of participants achieving disease control for ≥ 3 months.
Measure:Time to next therapy.
Time Frame:Up to 3 years after end of treatment.
Safety Issue:
Description:Time from end of treatment to starting next anti-myeloma therapy.
Measure:Progression free survival.
Time Frame:Up to 3 years after end of treatment.
Safety Issue:
Description:Proportion of participants remaining progression free or surviving at a given time.
Measure:Minimal Residual Disease.
Time Frame:From start of treatment to end of treatment, up to 24 months
Safety Issue:
Description:Rate of molecular minimal residual disease (MRD) negativity.

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Corvus Pharmaceuticals, Inc.

Last Updated

February 19, 2020