Recent Updates
Recently added Catalysts

Casdatifan

Phase 3

Metastatic Clear Cell Renal Cell Carcinoma | Small molecule | Oncology |Arcus Biosciences, Inc.|Last Updated: Jun 2, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment720
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07011719Study of Casdatifan and Cabozantinib Versus Placebo and Cabozantinib in Patients With Advanced Clear Cell Renal Cell CarcinomaPHASE3 RECRUITING 720Sep 8, 2025Dec 1, 2030Jun 2, 2026118 United States, Australia +13
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
Progression-free Survival (PFS) as assessed by Blinded Independent Central Review (BICR) according to RECIST 1.1
up to approximately 33 months
Secondary Endpoints
Overall Survival (OS)
up to approximately 64 months
Objective Response Rate (ORR) as assessed by Blinded Independent Central Review (BICR) according to RECIST 1.1
up to approximately 33 months
Duration of Response (DOR) as assessed by Blinded Independent Central Review (BICR) according to RECIST 1.1
up to approximately 33 months
Unlock Study Endpoints
Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Arm A (Experimental Arm)EXPERIMENTALCasdatifan and cabozantinib taken orally
Arm B (Comparator Arm)PLACEBO_COMPARATORPlacebo and cabozantinib taken orally
Interventions
NameTypeDescription
CasdatifanDRUGAdministered as specified in the treatment arm
CabozantinibDRUGAdministered as specified in the treatment arm
PlaceboDRUGAdministered as specified in the treatment arm
Unlock Study Design Details
Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites118

Inclusion Criteria: * Unresectable and measurable locally advanced or metastatic renal cell carcinoma with a primary clear cell component. * A Karnofsky Performance Status (KPS) score ≥ 80% * At least 1 target lesion measurable by computed tomography/magnetic resonance imaging per RECIST 1.1, not w...

Countries:United StatesAustraliaCanadaCzechiaFranceGermanyItalyJapanNetherlandsNew ZealandPolandRomaniaSouth KoreaSpainUnited Kingdom
Unlock Eligibility Criteria
Recent Changes (Last 90 Days)
LOWJun 2, 2026NCT07011719lastUpdatePostDate: changed
LOWJun 2, 2026NCT07011719lastUpdatePostDate: changed
LOWJun 2, 2026NCT07011719lastUpdatePostDate: changed
LOWMay 26, 2026NCT07011719primaryCompletionDate: changed
LOWMay 24, 2026NCT07011719studyFirstPostDate: changed