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Ciforadenant

Phase 1

Renal Cell Cancer | Small molecule | Oncology |Corvus Pharmaceuticals, Inc.|Last Updated: Aug 30, 2021

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment502
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02655822Phase 1/1b Study to Evaluate the Safety and Tolerability of Ciforadenant Alone and in Combination With Atezolizumab in Advanced CancersPHASE1 COMPLETED 502 — — Jan 1, 2016Jul 1, 2021Aug 30, 202120 United States, Australia +1
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Study Endpoints
Primary Endpoints
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.
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Cohort 1 - ClosedEXPERIMENTALCiforadenant
Cohort 2 - ClosedEXPERIMENTALCiforadenant
Cohort 3 - ClosedEXPERIMENTALCiforadenant
Cohort 4EXPERIMENTALCiforadenant + atezolizumab
Cohort 5 - ClosedEXPERIMENTALCiforadenant
Interventions
NameTypeDescription
CiforadenantDRUG100 mg orally twice daily for the first 14 days of each 28-day cycle.
Ciforadenant + atezolizumabDRUGCiforadenant 100 mg orally twice daily in combination with atezolizumab intravenously.
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites20

Renal Cell Carcinoma Inclusion Criteria 1. Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2. 2. Documented pathologic diagnosis of clear cell RCC. 3. Relapsed or refractory to 1-2 prior lines of therapy containing at least an anti-PD-(L)1 agent. 4. Measurable disease according to RE...

Countries:United StatesAustraliaCanada
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