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Casdozokitug

Phase 2

Hepatocellular Carcinoma | Small molecule | Oncology |Coherus Oncology, Inc.|Last Updated: Apr 13, 2026

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
RandomizedACTIVE_CONTROLLEDBiomarker
Total Trials1
Total Enrollment72
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06679985A Trial of Casdozokitug in Combination With Toripalimab Plus Bevacizumab in Participants With Unresectable and/or Locally Advanced or Metastatic Hepatocellular CarcinomaPHASE2 ACTIVE NOT_RECRUITING 72 — — Dec 20, 2024Sep 1, 2027Apr 13, 202644 United States, Australia +4
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Study Endpoints
Primary Endpoints
Number of Participants with Treatment-emergent Adverse Events (TEAEs)
From date of first dose to 90 days after date of last dose (Up to approximately 27 months)
Objective Response Rate (ORR) by Investigator Review According to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Up to approximately 2 years
Secondary Endpoints
ORR by Investigator Review According to HCC Modified RECIST (mRECIST)
Up to approximately 2 years
Duration of Response (DoR) by Investigator Review According to RECIST v1.1
Up to approximately 2 years
DoR by Investigator Review According to HCC mRECIST
Up to approximately 2 years
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Arm A: Casdozokitug Lower Dose + Toripalimab + BevacizumabEXPERIMENTAL -
Arm B: Casdozokitug Higher dose + Toripalimab + BevacizumabEXPERIMENTAL -
Arm C: Toripalimab + BevacizumabACTIVE_COMPARATOR -
Interventions
NameTypeDescription
CasdozokitugDRUGSolution for infusion
ToripalimabDRUGSolution for infusion
BevacizumabDRUGSolution for infusion
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites44

Key Inclusion Criteria: * Unresectable locally advanced or metastatic HCC with diagnosis confirmed by histology/cytology or clinically by American Association for the Study of Liver Diseases criteria in cirrhotic participants. * Disease that is not amenable to curative surgical and/or locoregional ...

Countries:United StatesAustraliaCanadaHong KongSingaporeTaiwan
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Recent Changes (Last 90 Days)
MEDIUMMay 26, 2026NCT06679985Status: RECRUITING → ACTIVE_NOT_RECRUITING
LOWMay 24, 2026NCT06679985studyFirstPostDate: changed