Propanc Biopharma Initiates Feasibility Assessment for PRP in Advanced Solid Tumors

Propanc Biopharma's decision to engage Avance Clinical Pty Ltd as CRO for its first-in-human Phase 1b study of PRP signals the point at which years of non-clinical development convert into regulatory-facing documentation, and the feasibility assessment now underway will determine whether Australian clinical trial centers can support the protocol before a Clinical Trial Application (CTA) is filed in Q4 2026.

The preparatory scope assigned to Avance Clinical covers a detailed review of the Investigator's Brochure, preparation of a Briefing Document derived from that IB, and finalization of a Clinical Trial Protocol built from a jointly prepared Clinical Trial Synopsis. Those documents will be distributed to investigators across multiple Australian centers to collect site-level feedback, a structured feasibility step that precedes CTA submission and shapes site selection for the multicenter investigation.

The study itself is a two-part, open-label, dose-escalation and dose-expansion design enrolling up to 40 patients with advanced solid tumors. Part A applies a Bayesian Optimal Interval (BOIN) design with backfill (BF-BOIN) across up to five dose levels to identify the maximum tolerated dose and recommended doses for optimization. Part B expands into tumor-specific cohorts at the selected doses to evaluate safety, tolerability, and preliminary antitumor activity. PRP will be administered as a weekly intravenous infusion on Days 1, 8, 15, and 22 of each 28-day cycle, with pharmacokinetic and pharmacodynamic endpoints embedded alongside safety and tolerability assessments.

For regulatory affairs leads tracking first-in-human programs in Australia, the structure reflects standard Therapeutic Goods Administration (TGA) CTA pathway expectations: IB-grounded briefing documents, investigator feasibility loops, and protocol finalization before submission. Propanc has also indicated that GMP manufacture of PRP is planned to commence this year, meaning CMC readiness and clinical supply timelines are running in parallel with the regulatory package.

The company reports that development of PRP has drawn on nearly two decades of scientific research, non-clinical and clinical evidence, formulation development, API purification, and manufacturing process development, a timeline that underscores the documentation burden QA and regulatory teams will need to organize coherently for TGA review.

The CTA submission target of Q4 2026 sets a near-term checkpoint against which the feasibility assessment outcomes, protocol finalization, and GMP manufacturing readiness will all need to converge.

Source: Propanc Biopharma via GlobeNewswire, 18 August 2026.