Race Oncology garners ethics approval for RC220 Phase 1 solid tumour trial

Race Oncology Ltd has the ethics green light from Bellberry Human Research Ethics Committee (HREC) for its Phase 1 dose escalation clinical trial assessing RC220 bisantrene alone and in combination with doxorubicin, in patients with solid tumours.

Significant milestone

“Receiving human ethics approval for the first RC220 trial is a significant milestone for Race, in line with our vision to improve cancer patient treatment by developing new cardioprotective therapies with anticancer benefits,” Race CEO and managing director Dr Daniel Tillett said.

The trial will assess the safety, tolerability and pharmacokinetics of RC220 and will proceed under the supervision of principal investigator Dr Mahmood Alam as an open-label, multi-centre, Phase 1 study conducted in two stages.

It will be conducted in collaboration with the Cancer Care Foundation, and that organisation’s lead clinical site, Southside Cancer Care Centre, can now start enrolling patients for the trial, subject to institutional approval and site activation this month, with up to nine other sites to follow.

Dose escalation

Stage 1 will start with a dose escalation of RC220, where up to 33 patients will be enrolled and receive intravenous (IV) infusion of RC220 alone on Day 1 before progressing to a combination treatment, where patients will receive intravenous (IV) RC220 followed by IV doxorubicin on a 21-day cycle.

This expansion stage will recruit patients with solid tumours who have not previously been treated with doxorubicin or other anthracyclines.

The dose escalation methodology uses a Bayesian statistical design to dose participants until the maximum tolerated combined dose (MTCD) is reached.

The partnership already has a good understanding of what the ideal dose will be from the hundreds of patients treated with bisantrene over the years, but because RC220 is a new formulation of bisantrene, health regulators such as the TGA, EMA or FDA require that it is treated as a new formulation and a “first-in-human” drug that has only ever been tested on animals.

All first-in-human drugs are required to undergo a human dose escalation stage, even if the active drug substance in the formulation is very well understood in the clinic.

Patients in the trial will continue to be treated until they reach either successful control of disease, disease progression, unacceptable toxicity or withdrawal of consent.

Patients will receive the optimal dosage of RC220 in combination with doxorubicin to confirm the safety of the combination and study a range of exploratory endpoints, including cardioprotection, anticancer, anti-ageing and other clinical biomarkers, such as the effects of RC220 on the m6 A RNA regulatory system.

Once investigators determine a MTCD, all accumulated safety and pharmacokinetic data will be analysed before Stage 2 begins.

Independent review of protocol

“This first approval is an important landmark for Race as it is an independent review of our protocol as well as our preclinical work and allows us to recruit additional sites to the trial,” Race chief medical officer, Dr Michelle Rashford said.

“We are close to patients receiving RC220 for the first time. I would like to thank Dr. Alam and his team for their work in achieving this approval.”

Cancer Care Foundation founder, chair and CEO Dr. Tony Noun said: “Congratulations to Race, to our clinical trial director, Dr Alam, and our Cancer Care Foundation team for helping to get us to this important milestone. Another step in our quest to improve outcomes for cancer patients.”

Next steps

Next steps for the trial include institutional approval and activation of the lead site by George Clinical to allow for recruitment of the first patient.

The approval of the ethics package has also enabled the company to submit the trial data package to the corresponding ethics and regulatory authorities in Hong Kong and South Korea.

Race expects that most Australian sites will be activated by George Clinical in Q1 or Q2 of the 2025 calendar year.

The Hong Kong and South Korean sites have a longer regulatory review process, and activation is expected in Q3 2025.