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Namodenoson

Phase 3

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

Target and mechanism

ModalitySmall molecule

Also known as Namodenoson 25mg

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment471

FDA Designations

ORPHAN_DRUGFAST_TRACK

Clinical trial landscape

Namodenoson · 2 trials · 4 indications

Phase 3 1Phase 2 1
NCT05201404Namodenoson in the Treatment of Advanced Hepatocellular Carcinoma in Patients With Child-Pugh Class B7 CirrhosisHepatocellular Carcinoma
RECRUITING471 Analytics
PHASE3RECRUITING
Namodenoson in the Treatment of Advanced Hepatocellular Carcinoma in Patients With Child-Pugh Class B7 Cirrhosis
Hepatocellular Carcinoma
NCT05201404471
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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

Adverse Events
Every 2 weeks, assessed up to 1 year

Assessments of adverse events (AEs) will include characterization of type, incidence, severity (graded by CTCAE v5.0), seriousness, and relationship to treatment.

Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) Change from baseline
Every 2 weeks, assessed up to 1 year

Eastern Cooperative Oncology Group (ECOG) Performance Status (PS), which is a scale of functioning, from 0 (normal activity) to 5 (death)

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
Namodenoson 25 mgEXPERIMENTALnamodenoson capsule, 25 mg, administered orally, twice daily for consecutive 28-day cycles

Interventions

NameTypeDescription
NamodenosonDRUGAdenosine A3 Receptor (A3AR) agonist
PlaceboDRUGControl arm
Namodenoson 25mgDRUGoral capsule
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Eligibility Criteria

Age Range18 Years to 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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Frequently asked questions about Namodenoson

What is Namodenoson used for?

Namodenoson is an investigational small molecule being studied for the treatment of pancreatic adenocarcinoma and hepatocellular carcinoma. It is currently in clinical development for these oncology indications, including a Phase 3 trial for advanced hepatocellular carcinoma in patients with Child-Pugh Class B7 cirrhosis.

What does Namodenoson target?

Namodenoson is a small molecule that acts as an A3 adenosine receptor agonist. It is being studied for its potential effects in oncology, specifically in pancreatic adenocarcinoma and hepatocellular carcinoma, though its exact mechanism of action in these cancers is still under investigation.

Who makes Namodenoson?

Namodenoson is being developed by Can-Fite Biopharma Ltd, a biopharmaceutical company traded under the ticker CANF. The company is conducting clinical trials for Namodenoson in advanced hepatocellular carcinoma and advanced pancreatic cancer.

What phase is Namodenoson in?

Namodenoson is in Phase 3 clinical development for advanced hepatocellular carcinoma, with a Phase 2 trial also ongoing for advanced pancreatic cancer. It is an investigational drug and has not been approved by the FDA, though it has received orphan drug and fast track designations.

What clinical trials is Namodenoson in?

Namodenoson is being evaluated in two clinical trials. NCT05201404 is a Phase 3, randomized, double-blind, placebo-controlled study in advanced hepatocellular carcinoma with Child-Pugh Class B7 cirrhosis, enrolling 471 patients. NCT06387342 is a Phase 2 study in advanced pancreatic cancer, enrolling 20 patients.

Is Namodenoson the same as Namodenoson 25mg?

Yes, Namodenoson is also known as Namodenoson 25mg. This alternative name refers to the same drug substance, which is being studied in clinical trials for hepatocellular carcinoma and pancreatic cancer.