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Ciforadenant

Phase 1

Multiple Myeloma | Small molecule | Oncology |Corvus Pharmaceuticals, Inc.|Trials Updated: Mar 11, 2022

Ciforadenant development status

Highest phase Phase 1
Registered trials 3 across 2 sponsors since Jan 2016

Ciforadenant target and mechanism

Molecular targetADORA2A
Target classAntagonist
ModalitySmall molecule

Also known as CPI-444

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials3
Total Enrollment533

FDA Designations

No designations recorded

Ciforadenant clinical trials

Ciforadenant · 3 trials · 4 indications

Phase 1 3
NCT04280328Study of Ciforadenant in Combination With Daratumumab in Patients With Relapsed or Refractory Multiple MyelomaMultiple Myeloma
COMPLETED7 Analytics
NCT03237988Study to Evaluate the Pharmacokinetics of a New Tablet Formulation of CPI-444 in Fed and Fasted Healthy Male and Female SubjectsHealthy Subjects
COMPLETED24 Analytics
NCT02655822Phase 1/1b Study to Evaluate the Safety and Tolerability of Ciforadenant Alone and in Combination With Atezolizumab in Advanced CancersRenal Cell Cancer
COMPLETED502 Analytics
PHASE1COMPLETED
Study of Ciforadenant in Combination With Daratumumab in Patients With Relapsed or Refractory Multiple Myeloma
Multiple MyelomaUnlock trial analytics
PHASE1COMPLETED
Study to Evaluate the Pharmacokinetics of a New Tablet Formulation of CPI-444 in Fed and Fasted Healthy Male and Female Subjects
Healthy SubjectsUnlock trial analytics
PHASE1COMPLETED
Phase 1/1b Study to Evaluate the Safety and Tolerability of Ciforadenant Alone and in Combination With Atezolizumab in Advanced Cancers
Renal Cell CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Safety and tolerability of ciforadenant in combination with daratumumab relapsed / refractory multiple myeloma.
From start of treatment to end of treatment, up to 24 months

Incidence of treatment-emergent adverse events, as assessed by NCI CTCAE v.5

AUC0-∞: AUC from time zero to infinity
Predose through 72 hours postdose

Area under the plasma concentration-time curve (AUC) from time zero to infinity

AUC0-tz: AUC from time zero to last quantifiable concentration
Predose through 72 hours postdose

AUC from time zero to the last quantifiable concentration

%AUCex: Percentage of AUC0-∞ that was due to extrapolation from the last quantifiable concentration to infinity
Predose through 72 hours postdose

Percentage of AUC0-∞ that was due to extrapolation from the last quantifiable concentration to infinity

Incidence of dose-limiting toxicities (DLTs) of ciforadenant as a single agent and in combination with atezolizumab
28 days following first administration of ciforadenant
Objective response rate per RECIST v1.1 criteria of ciforadenant as a single agent and in combination with atezolizumab
From start of treatment to end of treatment, up to 72 months
Incidence of treatment-emergent adverse events, as assessed by NCI CTCAE v.4.03, of ciforadenant as a single agent and in combination with atezolizumab
Continuously, up to 72 months
Mean and median Area under the curve (AUC) of ciforadenant
Up to 12 months
Mean and median Maximum concentration (Cmax) of ciforadenant
Up to 12 months
Identify the MDL (maximum dose level) of single agent ciforadenant
From start of treatment to end of treatment, up to 72 months.

Secondary Endpoints

Overall response rate.
From start of treatment to end of treatment, up to 24 months
Duration of response.
From start of treatment to end of treatment, up to 24 months
Disease control rate.
From start of treatment to end of treatment, up to 24 months
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Ciforadenant in combination with daratumumabEXPERIMENTALCiforadenant 100 mg orally twice daily in combination with daratumumab IV 16 mg/kg.
Sequence ABCACTIVE_COMPARATOR100 mg CPI-444, given orally as a 1 × 100-mg capsule, after an overnight fast of at least 10 hours (fasted); 100 mg CPI-444, given orally as a 1 × 100-mg tablet, after an overnight fast of at least 10 hours (fasted); 100 mg CPI-444, given orally as a 1 × 100-mg tablet, 30 minutes after the start of a high-fat breakfast (fed).
Sequence BCAACTIVE_COMPARATOR100 mg CPI-444, given orally as a 1 × 100-mg tablet, after an overnight fast of at least 10 hours (fasted); 100 mg CPI-444, given orally as a 1 × 100-mg tablet, 30 minutes after the start of a high-fat breakfast (fed); 100 mg CPI-444, given orally as a 1 × 100-mg capsule, after an overnight fast of at least 10 hours (fasted).
Sequence CABACTIVE_COMPARATOR100 mg CPI-444, given orally as a 1 × 100-mg tablet, 30 minutes after the start of a high-fat breakfast (fed); 100 mg CPI-444, given orally as a 1 × 100-mg capsule, after an overnight fast of at least 10 hours (fasted); 100 mg CPI-444, given orally as a 1 × 100-mg tablet, after an overnight fast of at least 10 hours (fasted).
Cohort 1 - ClosedEXPERIMENTALCiforadenant
Cohort 2 - ClosedEXPERIMENTALCiforadenant
Cohort 3 - ClosedEXPERIMENTALCiforadenant
Cohort 4EXPERIMENTALCiforadenant + atezolizumab
Cohort 5 - ClosedEXPERIMENTALCiforadenant

Interventions

NameTypeDescription
CiforadenantDRUG100 mg orally twice daily for 28-day cycles
daratumumabDRUG16 mg/kg administered intravenously as follows based on 28-day cycles: * Cycles 1 - 2: Days 1, 8, 15, and 22 * Cycles 3 - 6: Days 1 and 15 * Cycles 7 - 24: Day 1
CPI-444 CapsulesDRUG100mg Capsule
CPI-444 TabletsDRUG100mg Tablets
Ciforadenant + atezolizumabDRUGCiforadenant 100 mg orally twice daily in combination with atezolizumab intravenously.
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Eligibility Criteria

Age Range18 Years to 80 Years
SexALL
Healthy VolunteersNo
Study Sites1

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 ant...

Countries:United StatesAustraliaCanada
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Competitive Landscape -Multiple Myeloma 338 trials

Frequently asked questions about Ciforadenant

What is ciforadenant?

Ciforadenant is an investigational small molecule cancer therapy developed by Corvus Pharmaceuticals, Inc. (ticker CRVS). It has been studied in clinical trials for multiple myeloma and renal cell cancer, as well as metastatic castration resistant prostate cancer. It is not an approved medicine and remains in clinical development.

What does ciforadenant target?

Ciforadenant targets ADORA2A, the adenosine A2A receptor, and acts as an antagonist. By blocking this receptor, the drug is designed to interfere with adenosine-mediated signaling in the tumor microenvironment. This target class places ciforadenant among small molecule adenosine pathway inhibitors being studied in oncology.

What is ciforadenant used for?

Ciforadenant has been studied in multiple myeloma and renal cell cancer. One trial evaluated it with daratumumab in relapsed or refractory multiple myeloma, and a separate Phase 1/1b study enrolled patients with renal cell cancer and metastatic castration resistant prostate cancer. It is investigational and not approved for any use.

Who makes ciforadenant?

Ciforadenant is developed by Corvus Pharmaceuticals, Inc., which trades under the ticker CRVS. The company is the sponsor of the clinical program evaluating the drug in hematologic and solid tumor cancers.

What phase is ciforadenant in?

Ciforadenant is in Phase 1 development. Its trials are listed as Phase 1 or Phase 1/1b and have been completed, with no active trials currently recorded. The drug is investigational and has not been approved by the FDA for any indication.

What clinical trials is ciforadenant in?

Ciforadenant has been evaluated in two completed studies. NCT04280328 tested ciforadenant with daratumumab in relapsed or refractory multiple myeloma, enrolling 7 patients in the United States. NCT02655822 was a Phase 1/1b study of ciforadenant alone and with atezolizumab in advanced cancers, enrolling 502 patients across the United States, Australia, and Canada.