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CPI-444

Phase 1

Undisclosed | Small molecule | Other |Corvus Pharmaceuticals, Inc.|Trials Updated: Mar 11, 2022

CPI-444 development status

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

CPI-444 target and mechanism

Molecular targetadenosine A2a receptor
Target classReceptor
ModalitySmall molecule

Also known as CPI-444 Capsules, Ciforadenant

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials3
Total Enrollment533

FDA Designations

No designations recorded

CPI-444 clinical trials

CPI-444 · 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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Frequently asked questions about CPI-444

What is CPI-444?

CPI-444 is an investigational small molecule drug developed by Corvus Pharmaceuticals, Inc. (ticker CRVS). It is being studied in clinical development and has been evaluated in a Phase 1 trial. CPI-444 is also known as CPI-444 Capsules.

What does CPI-444 target?

CPI-444 targets the adenosine A2a receptor, a receptor protein. By binding to this receptor, CPI-444 is designed to modulate adenosine signaling. The adenosine A2a receptor is part of the adenosine pathway, which can suppress immune responses in the tumor microenvironment.

Who makes CPI-444?

CPI-444 is being developed by Corvus Pharmaceuticals, Inc., a biopharmaceutical company with the ticker symbol CRVS. Corvus is responsible for the clinical development of CPI-444.

What phase is CPI-444 in?

CPI-444 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. The Phase 1 program includes one completed trial.

What clinical trials is CPI-444 in?

CPI-444 has been studied in one completed Phase 1 trial, NCT03237988. This trial evaluated the pharmacokinetics of a new tablet formulation of CPI-444 in fed and fasted healthy male and female subjects. It enrolled 24 participants in the United States.

Is CPI-444 the same as CPI-444 Capsules?

Yes, CPI-444 Capsules is another name for CPI-444. The drug is also referred to as CPI-444 Capsules, reflecting a capsule formulation. Both names refer to the same investigational compound developed by Corvus Pharmaceuticals.