Race Oncology Ltd is advancing its Phase 1 clinical trial of RC220, a bisantrene treatment, in combination with doxorubicin for patients with advanced solid tumors. The company has submitted the ethics and regulatory package to Bellberry Human Research Ethics Committee (HREC), with first patient treatment anticipated in Q1 CY2025. This trial aims to evaluate the safety and efficacy of RC220 in mitigating the side effects associated with anthracycline chemotherapy while improving cancer treatment outcomes.
The Phase 1 trial is an open-label study that will be conducted in two stages across multiple sites in Australia, Hong Kong, and South Korea. Stage 1 will focus on assessing the safety and tolerability of ascending doses of RC220, both alone and in combination with standard-of-care doses of doxorubicin. The primary objectives include identifying the maximum tolerated combination dose (MTCD), evaluating the pharmacokinetics of RC220, and examining the effects of RC220 on exploratory clinical biomarkers such as m6A RNA and cardiovascular capacity.
The trial will employ a Bayesian statistical design for dose escalation, which is expected to be more efficient than traditional methods. An interim analysis will be performed after the first cycle of combination treatment to determine the optimal dose of RC220 with doxorubicin.
Stage 2 will involve treating patients with solid tumors who have not previously received doxorubicin or other anthracyclines, using the optimal combination dose identified in Stage 1. This phase will generate additional data on safety, tolerability, cardioprotective effects (measured via VO2peak), anticancer efficacy, and the impact of RC220 on various biomarkers.
"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," said Race CEO Dr. Daniel Tillett.
In addition to the clinical trial progress, Race Oncology reported a strong financial position with $18.78 million in cash and cash equivalents as of December 31. Over two-thirds of the quarter’s expenditure ($2.1 million) was allocated to research and development (R&D) and drug manufacturing. This represents a $4.2 million increase from the previous quarter, driven by a $5.25 million R&D Tax Incentive payment and the conversion of $870,000 in options.
Race Oncology is also expanding its scientific team, with recent appointments including Dr. Megan Baldwin, founder and chief innovation officer of Opthea, as an independent non-executive director, and the addition of Dr. Kirsten Curnow and Dr. Sumit Shani to the scientific team. These additions reflect the company's commitment to advancing its research and development efforts.
Pending final ethics and governance approvals, site activation and first patient recruitment are anticipated in Q1 CY2025. The Phase 1 study is designed to establish foundational clinical evidence for larger Phase 2 multi-region studies in the USA, Europe, and Asia, with the goal of developing RC220 as a cardioprotective anticancer agent to improve health outcomes for cancer patients treated with anthracyclines.
