Race Oncology Ltd has opened patient enrolment at a second site for its RC220 Phase 1 Solid Tumour Clinical Trial.
The study has been designed to allow the company to glean human safety and pharmacokinetic statistics, identify the maximum tolerated combined dose of RC220 and doxorubicin and provide a first glimpse of clinical data on the cardioprotective, anticancer and m6A RNA activities of RC220.
The activation of this second site in the Central Coast Local Health District – Gosford and Wyong Hospitals – follows the earlier activation of the lead Australian site, Southside Cancer Centre, in Miranda, NSW.
Green light following approvals
The trial was given the green light to proceed following human ethics approval, site initiation and completion of all the required documentation.
The open-label, Phase 1 trial will be conducted at multiple sites across Australia, Hong Kong and South Korea.
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.”
The Phase 1 trial will use ascending doses of RC220 in up to 33 patients in Stage 1 to determine the asset’s safety, tolerability, pharmacokinetics, maximum tolerated dose in combination with doxorubicin (MTCD), and effects on a range of clinical biomarkers including m6A RNA.
The trial will use a Bayesian design, which allows for greater trial flexibility and speed than traditional approaches.
Optimal dosage
Following an interim analysis of the data, clinicians will determine the optimal dosage of RC220 in combination with doxorubicin in an additional 20 patients in Stage 2 for further safety, tolerability,and preliminary cardioprotective and anticancer efficacy signals.
The company conducted a recent meta-analysis of single-agent doxorubicin treatment that identified overall response rates to doxorubicin of up to 35% 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.
The company’s preclinical studies also discovered there was enhancement of the cancer-killing activity of doxorubicin by bisantrene in 85% of 143 cancer cell lines screened.