Description:
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.
Title
- Brief Title: Study of Ciforadenant in Combination With Daratumumab in Patients With Relapsed or Refractory Multiple Myeloma
- Official Title: An Open-Label Study of Ciforadenant 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
Interventions
Drug | Synonyms | Arms |
---|
Ciforadenant | CPI-444 | Ciforadenant in combination with daratumumab |
daratumumab | | Ciforadenant in combination with daratumumab |
Purpose
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.
Trial Arms
Name | Type | Description | Interventions |
---|
Ciforadenant in combination with daratumumab | Experimental | Ciforadenant 100 mg orally twice daily in combination with daratumumab IV 16 mg/kg. | |
Eligibility Criteria
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.
Maximum Eligible Age: | 80 Years |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Safety and tolerability of ciforadenant in combination with daratumumab 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 |
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 2 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 2 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
September 28, 2020