Propanc Biopharma, Inc. is advancing its investigational cancer drug PRP into a Phase 1b clinical trial in Australia, aiming to enroll up to 50 patients with advanced solid tumors, including pancreatic, ovarian and refractory prostate cancers. The multicenter, open-label study will evaluate safety, tolerability, pharmacokinetics and preliminary antitumor activity through two sequential phases: dose escalation followed by dose expansion.
In Phase 1b, patients will receive weekly intravenous infusions on Days 1, 8, 15 and 22 of each 28-day cycle. The study’s Part A will use a Bayesian Optimal Interval design to identify the maximum tolerated dose and up to two recommended doses across up to five dose levels. Part B will assess safety and preliminary antitumor activity in tumor-specific expansion cohorts.
Manufacturing progress is advancing toward the trial’s February 2027 start. Good Manufacturing Practice (GMP) production is underway, with two scale-up runs scheduled for this month and an engineering run planned for late October. Raw drug substance supply for PRP is secured, and assay development—including polymerase/pharmacokinetic method validation and an anti-drug antibody assay—is in progress. In-use stability testing of the finished PRP formulation is also scheduled.
Supporting clinical trial documentation, including the Investigator’s Brochure and protocol, is being prepared for Australian investigators. Human Research Ethics Committee (HREC) submission is planned for November 2026, following feasibility assessments at trial sites.
Propanc CEO James Nathanielsz stated the company is making progress toward a pivotal milestone as it advances PRP into clinical testing. The trial marks a key step in the drug’s development pathway, building on prior manufacturing and validation efforts.
