Race Oncology (ASX:RAC) has announced the submission of the ethics and regulatory package to Bellberry Human Research Ethics Committee (HREC) for approval of a Phase 1 clinical trial of RC220.
The package is seeking the approval of a site at Southside Cancer Care Centre in Sydney, under the supervision of Principal Investigator Dr Mahood Alam.
The company said that regulatory and institutional packages have also been completed for submission to a second Australian site. It said that regulatory and institutional packages are in preparation for multiple locations in Hong Kong and South Korea. Additional site evaluation and recruitment is ongoing with the aim of achieving ten 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 and in combination with standard-of-care doses of doxorubicin in patients with advanced solid tumours. The trial objectives of Stage 1 are to identify the maximum tolerated combination dose, the pharmacokinetics of RC220, and the effects of RC220 on a range of exploratory clinical biomarkers, including m6A RNA and cardiovascular capacity.
An interim analysis of all data from Stage 1 will be performed after the last patient completes their first cycle of the combination treatment to identify 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 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.
Race said the Phase 1 study will set the foundational clinical evidence from which to advance to larger Phase 2 muti-region studies 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.
Race CEO and managing director Dr Daniel Tillett said, “I wish to thank the entire Race team and especially the Race clinical team for their extraordinary effort to reach this point in the clinical development of RC220. I also wish to thank George Clinical, the Cancer Care Foundation, and Dr Mahmood Alam for their support and advice. RC220 offers the potential to help millions of cancer patients avoid the detrimental side effects and accelerated-aging anthracycline chemotherapy can cause while also improving cancer treatment outcomes for cancer patients.”
Race chief medical officer Dr Michelle Rashford added, “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. 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.”
