Second Australian site activated for Phase 1 study in advanced solid tumours
Race Oncology (ASX: RAC) has just ticked off another milestone in its Phase 1 clinical trial of RC220, announcing that its second Australian trial site—Central Coast Local Health District (which includes Gosford and Wyong Hospitals)—is now open for patient enrolment. This follows the earlier activation of its lead site at Southside Cancer Centre in Miranda.
The Phase 1 trial is exploring the safety, tolerability, and pharmacokinetics of RC220 in combination with the well-known chemotherapy drug doxorubicin. The study is also looking into the potential cardioprotective and anticancer effects of RC220, and how it may influence the m6A RNA pathway—a key player in cancer biology.
RC220 is Race’s next-generation formulation of bisantrene, a drug with an interesting clinical legacy. The hope is that RC220 can not only boost the cancer-killing power of doxorubicin but also reduce its well-documented heart toxicity. That’s particularly relevant for patients battling advanced or metastatic cancers like breast, lung, ovarian, bladder, and more.
Race’s CEO Dr Daniel Tillett says the second site activation is a key move toward speeding up patient recruitment. “We’re grateful for the collaboration with our clinical partners and remain committed to advancing the clinical development of RC220,” he said.
The trial, which will run at multiple sites across Australia, Hong Kong, and South Korea, has a two-stage design. In Stage 1, up to 33 patients will receive ascending doses of RC220 to determine the maximum tolerated dose in combination with doxorubicin. Stage 2 will bring in an additional 20 patients to further assess safety, tolerability, and any early signs of cardioprotective or anticancer activity.
This study uses a Bayesian design—giving the team more flexibility and speed than traditional trial models.
Backing their belief in RC220, Race points to a meta-analysis showing doxorubicin has a response rate of up to 35% across a variety of solid tumours. In preclinical studies, Race also found that bisantrene enhanced doxorubicin’s effectiveness in 85% of 143 cancer cell lines.
