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Namodenoson

Phase 3

Hepatocellular Carcinoma | Small molecule | Oncology |Can-Fite Biopharma Ltd|Last Updated: Apr 29, 2025

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
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment471
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05201404Namodenoson in the Treatment of Advanced Hepatocellular Carcinoma in Patients With Child-Pugh Class B7 CirrhosisPHASE3 RECRUITING 471Mar 15, 2023Oct 1, 2026Apr 29, 202532 United States, Bosnia and Herzegovina +7
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Study Endpoints
Primary Endpoints
Overall Survival (OS)
From the time of randomization until the date of death from any cause, assessed up to 60 months

Median duration of survival

Secondary Endpoints
Progression-Free Survival (PFS)
From the time of randomization until the date of disease progression or death from any cause, assessed up to 60 months
Objective Response Rate (ORR)
Through study completion, with a median of 9 months
Incidence and nature of treatment-emergent adverse events
Through study completion, with a median of 9 months
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Namodenoson (CF102)EXPERIMENTALNamodenoson 25 mg orally BID, until disease progression or unacceptable adverse events
PlaceboPLACEBO_COMPARATORMatching placebo orally BID, until disease progression or unacceptable adverse events
Interventions
NameTypeDescription
NamodenosonDRUGAdenosine A3 Receptor (A3AR) agonist
PlaceboDRUGControl arm
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites32

Inclusion Criteria: 1. Males and females at least 18 years of age. 2. Diagnosis of HCC: * For patients without cirrhosis at the time of diagnosis, histologic confirmation is required (archival tissue is acceptable). * For patients with underlying cirrhosis at the time of diagnosis, diagnosis...

Countries:United StatesBosnia and HerzegovinaBulgariaIsraelMoldovaPolandRomaniaSerbiaSlovakia
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT05201404primaryCompletionDate: changed
LOWMay 24, 2026NCT05201404studyFirstPostDate: changed