Study of Ciforadenant in Combination With Daratumumab in Patients With Relapsed or Refractory Multiple Myeloma

Corvus Pharmaceuticals

Status and phase

Completed

Phase 1

Conditions

Multiple Myeloma

Treatments

Drug: daratumumab

Drug: Ciforadenant

Study type

Interventional

Funder types

Industry

Identifiers

NCT04280328

CPI-444-003

Details and patient eligibility

About

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

Enrollment

7 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Relapsed or refractory myeloma.
Must have been exposed to at least 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.