Race Oncology (ASX: RAC) has received ethics approval from the Bellberry Human Research Ethics Committee (HREC) to begin a Phase 1 clinical trial of its RC220 bisantrene formulation in combination with doxorubicin for patients with solid tumours.
This approval paves the way for the Southside Cancer Care Centre in Miranda, NSW, to start patient enrollment in March 2025, pending institutional approval. Up to nine additional sites are expected to follow.
What’s the Trial About?
The Phase 1 study will be conducted in two stages:
- Stage 1 (Dose Escalation) – Up to 33 patients will receive intravenous (IV) RC220 alone before moving to RC220 combined with doxorubicin on a 21-day cycle. A Bayesian statistical model will determine the maximum tolerated combined dose (MTCD).
- Stage 2 (Expansion Stage) – Once the optimal dose is confirmed, the trial will expand to patients who have not previously been treated with doxorubicin or other anthracyclines. This stage will focus on safety, cardioprotection, anticancer effects, and biomarkers related to RC220’s mechanism of action.
Why This Matters
Race Oncology’s CEO, Dr. Daniel Tillett, called this milestone a significant step forward in developing cardioprotective cancer treatments.
“We are thrilled to receive human ethics approval for our first RC220 trial, which aligns with our vision of improving cancer treatment outcomes,” Dr. Tillett said.
Chief Medical Officer Dr. Michelle Rashford added, “This independent review validates our protocol and preclinical research. We’re now moving closer to having patients receive RC220 for the first time.”
Next Steps & Trial Expansion
- Patient recruitment is expected to begin in March 2025 at Southside Cancer Care Centre.
- Additional sites across Australia, Hong Kong, and South Korea will follow, with international site activation expected by Q3 2025.
- Data from this Phase 1 trial will inform future clinical development and regulatory submissions.
With RC220 now entering the clinic, Race Oncology is advancing its mission to develop innovative, safer cancer therapies with both anticancer and cardioprotective benefits.
