Race activates its first Phase I trial site for cardioprotective anticancer drug candidate

Race Oncology activates first Australian site for Phase I trial of potential cancer and cardioprotective therapeutic RC220, enabling patient enrolments
This comes after governance approval announced today, and Human Research Ethics Committee approval for the site in late March
The company has also received human ethics approval this week for the Phase I RC220 trial at Gosford and Wyong Hospitals

Special Report: Race Oncology is enabling patient enrolments at its lead Australian site for the Phase I trial of its potential cancer and cardioprotective therapeutic in advanced solid tumours, RC220.

The activation of Southside Cancer Centre in Miranda, NSW – including enablement of patient enrolments – follows governance approval, completion of site initiation and all documentation for the site after it received Human Research Ethics Committee (HREC) approval in March.

Race Oncology (ASX:RAC) earlier this week revealed it had also received Bellberry Human Research Ethics Committee approval at Gosford and Wyong Hospitals.

That approval allowed both of those NSW Central Coast hospitals to enrol patients in the Phase I trial subject to final site approval and activation, expected during April.

The Phase I trial is designed to assess the safety, tolerability and pharmacokinetics (PK) of RC220 alone and in combination with doxorubicin, in patients with solid tumours.

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.

Race expects activation of most Australian sites by end of Q2

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

Race expects most Australian sites will be activated by contract research organisation George Clinical by the end of Q2 CY25.

Hong Kong and South Korean sites had a longer regulatory review process, with activation 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.

The approvals are ‘highly encouraging’

Race CEO and managing director Dr Daniel Tillett said receiving the second human ethics approval for the comapny’s Phase I trial so soon after the first approval was “both highly encouraging and a testament to the dedication of the team at Race”.

He added: “I am proud of the hard work and dedication from the Race clinical team, George Clinical and CCF in reaching this point. I look forward to soon treating the first patient with RC220 and beginning the process of advancing RC220 as a potential new treatment able to improve cancer therapy while protecting patients from the serious side effects of cancer treatment.”

Chief medical officer Dr Michelle Rashford said the second ethics approval “provided Race with further momentum for the study and in bringing RC220 to cancer patients”.

It is expected HREC approval will be received for additional trial sites in Australia, Hong Kong and South Korea over the following months.

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

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