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Highlights:
Race Oncology Ltd has commenced patient enrolment for the RC220 Phase 1 clinical trial at the Southside Cancer Care Centre in New South Wales.
The study will assess safety, tolerability, and biomarker responses in patients receiving RC220 in combination with doxorubicin.
The trial is set to expand across Australia, Hong Kong, and South Korea using a Bayesian adaptive design for efficiency.
Race Oncology Ltd (ASX:RAC, OTC:RAONF), operating in the biotechnology sector, has initiated patient enrolment for its RC220 Phase 1 clinical trial in solid tumours. The first Australian site, located at Southside Cancer Care Centre in Miranda, New South Wales, has been activated following ethics approval and site initiation. This milestone marks a significant step in advancing the clinical development of RC220.
Study Objectives and Trial Design
The trial aims to evaluate the safety and pharmacokinetics of RC220 when combined with doxorubicin in patients with advanced solid tumours. Additionally, the study seeks to determine the maximum tolerated combined dose (MTCD) and investigate RC220’s impact on cardioprotection and RNA modification activity.
An open-label, multi-centre design has been implemented to enhance data collection and adaptability. The study will be conducted across multiple locations, including Australia, Hong Kong, and South Korea, leveraging a Bayesian adaptive design to improve trial efficiency. This approach allows for real-time adjustments based on emerging data, optimizing treatment regimens as the study progresses.
Enrolment and Treatment Strategy
The trial will initially include a group of patients receiving escalating doses of RC220 to assess its tolerability and safety. Following an interim analysis, an additional expansion cohort will be enrolled to explore optimal dosing and assess preliminary efficacy. The study framework ensures a systematic approach to understanding the therapeutic impact of RC220.
Race Oncology’s preclinical research has demonstrated that RC220 enhances the cancer-killing activity of doxorubicin across a wide range of cancer cell lines. Complementing this research, a meta-analysis of doxorubicin monotherapy has highlighted response rates in advanced and metastatic cancer cases, reinforcing the significance of this study.
Industry and Clinical Impact
The activation of this Australian site aligns with Race Oncology’s broader strategy to develop novel treatment approaches within the ASX 200, Healthcare Stocks sector. By focusing on the dual benefits of RC220—anticancer efficacy and cardioprotection—the company aims to address critical challenges in cancer treatment.
Dr. Daniel Tillett, CEO of Race Oncology, acknowledged the collaborative effort behind this milestone, highlighting the contributions of the Race clinical team, George Clinical, and CCF in progressing to this stage. He expressed anticipation for the treatment of the first patient and the continued advancement of RC220 as a therapeutic innovation.
