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

Overview

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.

SparkCures ID 1087
Trial Phase Phase 1
Enrollment 28 Patients
Treatments
Trial Sponsors
  • Corvus Pharmaceuticals, Inc.
NCT Identifier

NCT04280328

Am I Eligible?

The following criteria is a partial list of reasons why patients may or may not be eligible to participate in this clinical trial. Further evaluation with a medical professional will be required to determine full eligibility.

The following criteria is provided for health care professionals.

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.

US Trial Locations

Accepting Patients

The following is a listing of trial locations that are open and accepting patients.

Maryland

Resources

There are no resources, links or videos to display for this clinical trial.