Ethics Approval Clears Path for RC220 Clinical Trial

Race Oncology (ASX:RAC) has received a major regulatory green light, with the Bellberry Human Research Ethics Committee (HREC) granting approval for its Phase 1 clinical trial of RC220 in combination with doxorubicin for solid tumour patients. This milestone enables the lead site, Southside Cancer Care Centre in Miranda, NSW, to begin enrolling patients, subject to final institutional approvals and site activation in March 2025. Up to nine additional sites are expected to follow.

Race CEO & Managing Director, Dr. Daniel Tillett, described the approval as a “significant milestone” for the company.

“Receiving human ethics approval for the first RC220 trial is a major step forward in our mission to develop cardioprotective therapies with anticancer benefits. This achievement is a testament to the efforts of the Bellberry HREC, as well as the Race and George Clinical teams,” he said.

 Distinct Approach to Cancer Treatment

The trial aims to assess the safety, tolerability, and pharmacokinetics of RC220, a reformulated version of bisantrene, alone and in combination with doxorubicin. It will be conducted in two stages:

• Stage 1: A dose-escalation phase with up to 33 patients receiving intravenous RC220 alone before progressing to a combination regimen with doxorubicin. A Bayesian design will guide dose escalation until the maximum tolerated combined dose (MTCD) is reached.
• Stage 2: An expansion phase recruiting patients with solid tumours who have not been previously treated with doxorubicin or anthracyclines. This stage will confirm the safety of the combination and assess exploratory endpoints, including cardioprotective and anticancer effects, along with impact on the m6A RNA regulatory system.

Race Chief Medical Officer, Dr. Michelle Rashford, highlighted the significance of the approval.

“This is an important landmark for Race, as it validates our protocol and preclinical work while allowing us to expand the trial to additional sites. We are getting closer to the moment when patients will receive RC220 for the first time,” she said.

Expanding the Trial Footprint

With ethics approval secured, the next steps include institutional approval and site activation to enable patient recruitment. The approval also allows Race to submit trial data for regulatory review in Hong Kong and South Korea, where additional trial sites are planned.

Cancer Care Foundation Founder, Chair & CEO, Dr. Tony Noun, praised the collaborative effort that led to this milestone.

“Congratulations to Race, our Clinical Trial Director Dr. Alam, and the Cancer Care Foundation team for reaching this critical stage. This is another step in our shared goal of improving cancer patient outcomes,” he said.

Key Questions Answered

• Will 33 patients be required in Stage 1? Not necessarily. The trial’s Bayesian statistical design allows flexibility, with an expected patient range of 12 to 18 in this stage.
• Why is a dose-escalation phase needed if bisantrene has been used before? RC220 is a new formulation of bisantrene, which regulators treat as a “first-in-human” drug. Despite bisantrene’s extensive clinical history, all new formulations must undergo dose-escalation studies to meet regulatory requirements.
• When will additional trial sites be activated? Most Australian sites are expected to be active in Q1 or Q2 of 2025, while Hong Kong and South Korean sites will follow in Q3 due to longer regulatory processes.
• How can patients enrol in the trial? Patients should discuss participation with their treating oncologist or clinical trial study doctor at recruiting sites. Eligibility criteria must be met, and informed consent is required.

The Road Ahead for Race Oncology

With a strong pipeline and growing clinical footprint, Race Oncology is positioning itself at the forefront of oncology innovation. By leveraging RC220’s potential cardioprotective benefits alongside its anticancer properties, the company aims to address significant unmet needs in cancer care.

The success of this trial could pave the way for broader applications of RC220, solidifying Race Oncology’s place in the rapidly evolving oncology landscape.