Race Oncology (ASX: RAC) has submitted an ethics and regulatory package to Bellberry Human Research Ethics Committee (HREC) for approval of a Phase 1 clinical trial of RC220
The trial will be undertaken at the Australian lead site, Southside Cancer Care Centre (Miranda, NSW), under the supervision of Principal Investigator (PI), Dr Mahood Alam.
Following approval, this site will be activated for patient recruitment and institutional approval, with first patient recruitment anticipated in Q1 2025.
In parallel, regulatory and institutional packages have been completed for submission to a second Australian site immediately following HREC approval of the trial, with both sites planned to be activated simultaneously.
Regulatory and institutional packages are in advance preparation for multiple locations in Hong Kong and South Korea, with submissions anticipated in early Q1 2025. Additional site evaluation and recruitment is ongoing with the aim of achieving 10 active sites.
This open label, Phase 1 trial will be conducted in two stages. Stage 1 will assess the safety and tolerability of ascending doses of RC220 alone, as well as in combination with standard-of-care (SOC) doses of doxorubicin (Adriamycin) in patients with advanced solid tumours. The trial objectives of Stage 1 are to identify the maximum tolerated combination dose (MTCD), the pharmacokinetics of RC220, and the effects of RC220 on a range of exploratory clinical biomarkers, including m6A RNA and cardiovascular capacity.
The trial will use a Bayesian statistical design for the dose escalation stage, a design that has proven faster and more efficient than the traditional (3+3) dose escalation approach.
An interim analysis of all data from Stage 1 will be performed after the last patient completes their first cycle of the combination treatment with the aim of identifying the optimal dose of RC220 in combination with doxorubicin.
In Stage 2, RC220 will be used to treat patients with solid tumours who have not previously received doxorubicin or other anthracyclines using the optimal combination dose. Stage 2 will generate additional safety and tolerability data on the combination, cardioprotective (via VO2peak measurements) and anticancer efficacy data, and the effects of RC220 on a range of biomarkers.
Subject to HREC approval, Stage 2 is planned to commence while patients in Stage 1 continue treatment according to the study protocol.
This Phase 1 study will set the foundational clinical evidence from which to advance to larger Phase 2 muti- regions studies (USA, Europe and Asia) to advance the clinical development of RC220 as a potential cardioprotective anticancer agent aimed at improving the health outcomes of cancer patients treated with anthracyclines.
“This is a critical milestone for the team; selection and evaluation of an appropriate site and the start of the ethical review for this study,” Race Chief Medical Officer, Dr Michelle Rashford, said.
“Once we have the approval for the lead site, the team will focus on advancing patient recruitment as efficiently as possible to commence the assessment of the cardioprotective benefits of RC220 for patients treated with anthracyclines. I thank the clinical team and George Clinical for their efforts to date.”
