Race Oncology Ltd has kicked off its flagship oncology trial, dosing the first patient in its Phase 1 clinical trial investigating RC220 for the treatment of advanced solid tumours.
The initial dosing was carried out at the Southside Cancer Care Centre in Miranda, New South Wales, with no adverse effects or phlebitis reported.
Patient under care of lead investigator
The patient was treated under the care of the trial’s principal investigator, as the company begins clinical assessment of RC220’s safety, tolerability and pharmacokinetics.
Race CEO Dr Daniel Tillett said: “The safe dosing of the first patient in our solid tumour trial is a major milestone for Race Oncology and the beginning of an important program to assess the safety, tolerability and therapeutic potential of RC220.
“We are grateful to all the patients, investigators and clinical teams who have made this trial possible.
“I would also like to thank our shareholders for their strong and loyal support that has enabled us to bring RC220 to patients in the clinic."
RC220 is a novel reformulation of bisantrene, an anticancer drug with historical efficacy across various cancers and a favourable cardiotoxicity profile when compared to commonly used anthracyclines such as doxorubicin.
The current Phase 1 trial is designed to explore RC220 in combination with doxorubicin, with the aim of establishing the maximum tolerated combined dose (MTCD) in up to 33 patients during the trial’s first stage.
Study will look for early indicators
With a total of 20 additional patients anticipated for the second stage, the study will also assess early indicators of anticancer activity and cardioprotection.
Trial sites have been opened in Australia, with expansion planned to Hong Kong and South Korea.
A recently opened second Australian site at Gosford and Wyong Hospitals has begun enrolling patients.
The open-label trial will adopt a Bayesian design, which allows for greater efficiency and adaptability.
As patients are treated and monitored, emerging data is expected to guide dose escalation and treatment decisions.
RC220 combines historical clinical insights from more than 50 previous trials of bisantrene with new preclinical data from Race Oncology, which has shown that RC220 can significantly boost doxorubicin’s anticancer efficacy.
In laboratory tests, the combination demonstrated enhanced activity in 85% of cancer cell lines tested.
The company is also investigating RC220’s potential to modulate the m6A RNA pathway, following findings that bisantrene is a potent inhibitor of the FTO protein – an epigenetic regulator linked to cancer proliferation.