Race initiates first site for Phase I trial of cardioprotective anticancer drug

Southside Cancer Care Centre in Miranda initiated as first site for Race’s Phase I trial of RC220 in advanced solid tumours
Race awaiting governance approval to activate site for patient recruitment
Up to 53 patients to be enrolled in open-label study across multiple sites in Australia, Hong Kong and South Korea

Special Report: Race Oncology has initiated its lead trial site Southside Cancer Care Centre in Miranda, NSW, as the first location for its Phase I trial of its potential cancer and cardioprotective therapeutics RC220 in advanced solid tumours.

Race Oncology (ASX:RAC) has initiated Southside Cancer Care Centre in preparation for commencement of patient enrolment for its Phase 1 clinical trial of RC220 in combination with doxorubicin in advanced solid tumour patients.

Site initiation follows receipt of ethics approval for the trial earlier this month with the company now awaiting a governance green light as the final step to activate the site for patient recruitment.

The Phase 1 trial is a two-stage open-label study to be conducted across multiple sites in Australia, Hong Kong and South Korea.

Race expects that most Australian sites will be activated by contract research organisation George Clinical in the current quarter or next quarter.

The company said as Hong Kong and South Korean sites had a longer regulatory review process, activation was expected in the third quarter of 2025.

The company aims to have up to nine sites and up to 53 patients enrolled in the trial.

Investigating ascending doses of RC220

The Phase 1 trial will investigate ascending doses of RC220 to determine the safety, tolerability, pharmacokinetics and maximum tolerated combined dose (MTCD) with doxorubicin, and effects on a range of clinical biomarkers, including m6A RNA.

After interim analysis of the data from stage one of the trial, the optimal dosage of RC220 in combination with doxorubicin will be assessed in additional patients for further safety, tolerability, cardioprotective and anticancer efficacy signals.

Race said the trial would use a Bayesian design, enabling greater trial flexibility and speed than other approaches.

Reformulated drug with cardioprotective properties

RC220 is a reformulated version of bisantrene, an anthracene-based anticancer drug developed by Lederle Laboratories in the 1970s and 1980s, known for its reduced cardiotoxicity and lack of cardiotoxic effects.

Despite its effectiveness and prior approval for acute myeloid leukaemia in France, Race said its complex administration limited commercial use. RC220 is designed for easier clinical use via standard infusion.

Race believes it has a good understanding of what the ideal dose for RC220 may be from hundreds of patients treated with bisantrene over the years.

However, as a new formulation regulators require that RC220 be treated as a first-in-human drug only ever tested on animals, which is required to undergo a human dose escalation stage, even if the active drug substance was very well understood in the clinic.

‘Providing new hope for those fighting cancer’

Race CEO Dr Daniel Tillett said the company was pleased to have reached the milestone of its first clinical site initiation in preparation for patient enrolment as soon as the company is given governance approval.

“Southside Cancer Care Centre serves as our lead trial site in Australia,” he said.

“Initiation of our lead site moves us closer to launching our Phase I trial and, ultimately, to our mission of providing new hope for those fighting cancer.”

“This trial is open label in nature, so patient outcomes are obtained soon after patients are treated.”

He said Race would announce progress updates on the trial on a regular basis, but not at the individual patient level.

This article was developed in collaboration with Race Oncology, a Stockhead advertiser at the time of publishing.

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