Race Oncology Safely Advances RC220-Doxorubicin Combo in Solid Tumour Trial
Race Oncology has successfully dosed the first patient with its RC220 and doxorubicin combination in a Phase 1 trial for advanced solid tumours, reporting no dose-limiting side effects. This milestone marks a key step in evaluating the safety and potential cardioprotective benefits of the novel therapy.
- First patient safely dosed with RC220 plus doxorubicin at lead Australian site
- No treatment-related dose-limiting adverse effects observed
- Phase 1 trial underway across Australia, Hong Kong, and South Korea
- Trial uses Bayesian design to accelerate dose and safety assessments
- Focus on cardioprotection and enhanced anticancer activity in solid tumours
Trial Milestone Achieved
Race Oncology Limited has announced a significant clinical milestone with the safe dosing of the first patient receiving a combination of its investigational drug RC220 and the established chemotherapy agent doxorubicin. This event took place at the Southside Cancer Care Centre in Miranda, New South Wales, marking the first patient treated in the Phase 1 solid tumour trial’s combination therapy arm.
The absence of dose-limiting side effects in this initial patient is an encouraging sign for Race Oncology, which is developing RC220; a reformulated version of bisantrene; with the goal of improving treatment outcomes and reducing the cardiotoxic risks associated with doxorubicin. Doxorubicin, while effective against a broad range of cancers, is known for its potential to cause heart damage, a serious concern for patients undergoing chemotherapy.
Expanding Clinical Efforts Across Asia-Pacific
The trial is not limited to Australia; Race Oncology is actively working to open additional sites in Hong Kong and South Korea, reflecting a strategic push to gather diverse clinical data across multiple populations. The Phase 1 study is designed to assess safety, tolerability, pharmacokinetics, and the maximum tolerated combined dose of RC220 with doxorubicin in up to 33 patients during its first stage.
Following an interim analysis, the trial will expand to include another 20 patients to further evaluate safety and preliminary signals of cardioprotection and anticancer efficacy. The use of a Bayesian trial design is notable, as it allows for greater flexibility and potentially faster progression through dose escalation phases compared to traditional methods.
Scientific Rationale and Future Potential
RC220’s active ingredient, bisantrene, has a substantial clinical history with demonstrated activity in both solid and hematological cancers. Preclinical studies by Race Oncology have shown that bisantrene can enhance the cancer-killing effects of doxorubicin in a majority of tested cancer cell lines, suggesting a promising synergy. This combination could offer a dual benefit, maintaining or improving anticancer efficacy while mitigating the cardiotoxicity that limits doxorubicin’s use.
Race Oncology’s Vice President of Medical, Dr Simon Fisher, highlighted the encouraging early safety data and the company’s commitment to advancing this program. The company is also exploring partnerships and licensing opportunities to accelerate global access to RC220.
Looking Ahead
While these early results are promising, the trial remains in its initial stages, and further data will be critical to confirm both safety and efficacy. Investors and observers will be watching closely as Race Oncology progresses through the trial’s next phases and expands its clinical footprint.
Bottom Line?
Race Oncology’s safe combination dosing milestone sets the stage for critical efficacy data and potential market impact in cancer care.
Questions in the middle?
- Will RC220 demonstrate clear cardioprotective benefits alongside anticancer efficacy in later trial stages?
- How quickly can Race Oncology activate additional trial sites in Asia to accelerate patient recruitment?
- What partnerships or commercial strategies will Race pursue to maximise RC220’s global reach?