Namodenoson Meets Primary Safety End Point in Pretreated PDAC

Namodenoson (CF102) successfully met its primary end point of safety and tolerability in a phase 2a trial (NCT06387342) of patients with advanced pancreatic ductal adenocarcinoma (PDAC) who progressed following prior systemic therapies, according to a press release from the developer, Can-Fite BioPharma.¹

The A3 adenosine receptor (A3AR) agonist demonstrated a favorable safety profile in a heavily pretreated population, supporting its continued clinical evaluation in a disease setting where systemic options remain limited and often characterized by significant toxicity.

Namodenoson has also received the FDA’s orphan drug designation for the treatment of patients with pancreatic cancer.

Safety and Efficacy of Namodenoson in PDAC

The study, which enrolled patients with advanced PDAC who had failed at least 1 prior line of systemic therapy focused on the safety and preliminary activity of namodenoson monotherapy. No new safety signals were identified with namodenoson in this patient population, and the safety profile was consistent with what had been previously observed with namodenoson in other cancer types.

Beyond the primary safety end point, secondary efficacy data revealed that approximately one-third of the study participants remained alive at the time of the data cut-off. Median overall survival (OS) and progression-free survival (PFS) data were not yet mature at data cutoff; however, the company reported that, once they do mature, they will be shared during an upcoming scientific meeting.

The preliminary results highlight the potential for A3AR-targeted therapy in gastrointestinal malignancies. "The favorable safety profile observed in this difficult-to-treat population supports continued clinical evaluation of namodenoson," stated Salomon Stemmer, MD, a lead investigator at the Davidoff Center, Rabin Medical Center, in Israel.¹ “We are continuing to monitor survival outcomes as data mature.”

Phase 2a Pancreatic Cancer Trial Breakdown

The phase 2a trial was an open-label study designed to assess the safety, clinical activity, and pharmacokinetics of namodenoson in patients with locally advanced or metastatic pancreatic cancer.² A total of 20 patients with advanced PDAC received namodenoson at a dose of 25 mg orally twice daily in continuous 28-day cycles.

Enrollment was open to adults with histologically or cytologically confirmed PDAC who had progressed on at least 1 prior systemic treatment regimen or refused standard treatment, and had no standard therapies expected to be curative. They also had an ECOG performance status of 0 to 2, measurable disease per RECIST v1.1, and a life expectancy of at least 8 weeks.

Exclusion criteria included receipt of systemic cancer therapy within 14 days of baseline visit or concurrently during the trial, persistent toxicity of at least grade 2 from prior cancer therapy, major surgery or radiation within 14 days of baseline visit, and uncontrolled or clinically unstable thyroid disease. Patients were also not permitted to have active second primary malignancy, uncontrolled arterial hypertension or congestive heart failure, severe medical or psychiatric conditions, or concomitant use of P-glycoprotein/breast cancer resistance protein inhibitors.

The primary end point was adverse events and ECOG performance status change from baseline. Secondary end points included OS, PFS, disease control rate, and duration of response.

The agent is also being evaluated as treatment for patients with hepatocellular carcinoma (HCC) in a phase 3 trial (NCT05201404), for patients with metabolic dysfunction-associated steatohepatitis in a phase 2b trial (NCT04697810).

Further, namodenoson has received been granted orphan drug designation in the US and Europe, as well as fast track designation in the US, for the treatment of second-line HCC.

References

1. Can-Fite's namodenoson successfully meets primary endpoint in phase 2a pancreatic cancer study. Can-Fite BioPharma. Published March 4, 2026. Accessed March 5, 2026. https://tinyurl.com/5fy7j5m3
2. Namodenoson treatment of advanced pancreatic cancer. ClinicalTrials.gov. Updated January 31, 2025. Accessed March 5, 2026. https://tinyurl.com/39vvhmjt