On August 18, 2026 Propanc Biopharma, Inc. (Nasdaq: PPCB) ("Propanc" or the "Company"), a biopharmaceutical company focused on developing novel treatments for chronic diseases, including recurrent and metastatic cancer, reported it has commenced finalization of a clinical trial protocol and will conduct a feasibility assessment for its First-In-Human (FIH), Phase 1b clinical study of PRP in up to 40 advanced cancer patients suffering from solid tumors. Preparatory activities for the multi-trial center investigation will be led by Avance Clinical Pty Ltd and will consist of a detailed review of the Company’s Investigator’s Brochure (IB), preparation of a Briefing Document from the IB, as well as finalization of a Clinical Trial Protocol using the jointly prepared Clinical Trial Synopsis which summarizes the design of the 40-patient study. The documents will be provided to Investigators in Clinical Trial Centers located across Australia for the world-first study to obtain detailed and thorough feedback as part of a feasibility assessment prior to the submission of a Clinical Trial Application planned for Q4 this year.

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The world-first clinical study is a Phase 1b, open‑label, dose escalation and dose expansion study of PRP in patients with advanced solid tumors. It will consist of a multicenter, open-label, two-part (dose escalation, Part A, and dose expansion, Part B) study to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary activity of PRP in participants with advanced solid tumors. PRP will be administered as a weekly intravenous (IV) infusion (Days 1, 8, 15 and 22 of every 28-day treatment cycle). Treatment with PRP may continue until a withdrawal criterion is met. Part A will use a Bayesian Optimal Interval (BOIN) design with target dose limiting toxicity (DLT) probability, with backfill (BF) allowed (BF-BOIN), to identify the maximum tolerated dose (MTD), if reached, and/or up to two recommended doses for optimization/expansion (RDO) of PRP. Up to 5 dose levels are planned for escalation. Following determination of the RDO(s) in Part A, Part B will further evaluate the safety, tolerability, and preliminary antitumor activity of PRP at the selected doses into one or more tumor specific expansion cohorts.

"The Feasibility Assessment in preparation of our FIH, Phase1b clinical study for PRP is a major step towards a significant, transformative milestone for the Company in the advancement of a first-in-class therapy for the treatment and prevention of metastatic cancer from solid tumors, such as pancreatic, ovarian and refractory prostate cancers," said Mr. James Nathanielsz, Propanc’s Chief Executive Officer. "The design of the Phase 1b study has been undertaken with the Company’s research and development team, our partners, and will be ably led by the Company’s appointed CRO, Avance Clinical, who have extensive experience in this field. Many hours have been spent so far preparing the Company’s supporting documents and it reflects the hard work and dedication for nearly two decades incorporating scientific research, non-clinical and clinical evidence, formulation development and API (active pharmaceutical ingredient) purification, and manufacturing process development to be ready for the Phase 1b study. We look forward to further announcements as we advance towards the submission of the CTA (Clinical Trial Application) and commencement of the GMP manufacture of PRP this year. I have every confidence these activities will result in significant anticipatory interest among the medical and scientific communities with a world-first therapeutic that reverses the malignancy of cancer cells and leaves healthy cells intact, free from side effects often observed with standard treatment regimen, whilst preventing cancer from returning and spreading. Metastatic cancer remains the single most common cause of death among sufferers from solid tumors."

(Press release, Propanc, AUG 18, 2026, View Source [SID1234670208])