Race Oncology (ASX:RAC) has announced the activation of the second site for patient enrolment for its Phase 1 clinical trial of RC220 (bisantrene), combined with doxorubicin, in patients with advanced solid tumours.
The site is at the Central Coast Local Health District (Gosford and Wyong Hospitals).
The open-label, Phase 1 trial will be conducted at multiple sites across Australia, Hong Kong, and South Korea. Central Coast Local Health District's activation follows that of the lead Australian trial site, Southside Cancer Centre in Sydney.
Race CEO Dr Daniel Tillett said, “The activation of our second clinical site enables us to accelerate patient recruitment for the Phase 1 clinical trial, aiding the collection of critical safety, tolerability and pharmacokinetics data. We’re grateful for the collaboration with our clinical partners and remain committed to advancing the clinical development of RC220.”
Race said the trial will use ascending doses of RC220 in up to 33 patients in stage one to determine its safety, tolerability, pharmacokinetics, maximum tolerated dose in combination with doxorubicin (MTCD), and effects on a range of clinical biomarkers including m6A RNA.
After an interim data analysis, the optimal dosage of RC220 in combination with doxorubicin will be assessed in an additional 20 patients in stage two for further safety, tolerability, and preliminary cardioprotective and anticancer efficacy signals.
A recent meta-analysis of single-agent doxorubicin treatment, undertaken by Race Oncology, has identified overall response rates to doxorubicin of up to 35 per cent in a wide range of advanced and metastatic solid tumour cancers including breast cancer, small cell lung cancer, ovarian cancer, bladder cancer, liver cancer, endometrial cancer, upper gastrointestinal cancer, thyroid cancer, non-small cell lung cancer, and prostate cancer. Preclinical studies by Race Oncology have also identified enhancement of the cancer-killing activity of doxorubicin by bisantrene in 85 per cent of 143 cancer cell lines screened.
