Can-Fite BioPharma Ltd. has announced the dosing of the first patient in its Phase IIa clinical trial (NCT06387342) evaluating Namodenoson in patients with advanced pancreatic adenocarcinoma. This multicenter, open-label trial aims to assess the safety, clinical activity, and pharmacokinetics of Namodenoson in patients whose disease has progressed following at least one prior line of therapy.
The trial will enroll approximately 20 evaluable patients who will receive oral Namodenoson at a dose of 25 mg twice daily in consecutive 28-day cycles. Regular safety evaluations will be conducted throughout the study. The primary endpoint is to characterize the safety profile of Namodenoson. Secondary endpoints include Objective Response Rate (ORR) per RECIST 1.1, Progression-Free Survival (PFS), Disease Control Rate (DCR), Duration of Response (DoR), and Overall Survival (OS).
Rationale for Namodenoson in Pancreatic Cancer
Dr. Michael Silverman, Can-Fite’s Medical Officer, stated, "We are excited to have the first patient enrolled and hope that we will be able to demonstrate the safety and efficacy of Namodenoson in the pancreatic cancer patient population. This trial provides us the opportunity to explore our innovative treatment approach for patients who are facing significant gaps in effective treatment options."
About Namodenoson
Namodenoson is a small, orally bioavailable drug that selectively binds to the A3 adenosine receptor (A3AR). The drug has been previously evaluated in Phase II trials for hepatocellular carcinoma and non-alcoholic fatty liver disease (NAFLD) / non-alcoholic steatohepatitis (NASH). A3AR is highly expressed in diseased cells, with low expression in normal cells, contributing to the drug's safety profile. The U.S. FDA has granted Orphan Drug Designation to Namodenoson for pancreatic cancer.
Trial Leadership
The study is being conducted by Dr. Salomon Stemmer at the Institute of Oncology, Rabin Medical Center, Israel, and by Dr. Al Mutar from the UT Southwestern Medical Center in the US.
