Race Oncology (ASX:RAC) has announced the site activation of Southside Cancer Care Centre in Sydney after receiving governance approval enabling the commencement of patient enrolment for its Phase 1 clinical trial of RC220 in combination with doxorubicin in advanced solid tumours patients.
The company said the Phase 1 trial will be open-label and conducted across multiple sites in Australia, Hong Kong and South Korea.
The trial will use ascending doses of RC220 in up to 33 patients to determine the safety, tolerability, pharmacokinetics, maximum tolerated combined dose (MTCD) in combination with doxorubicin, and effects on a range of clinical biomarkers.
The company said that after an interim analysis of the data, the optimal dosage of RC220 in combination with doxorubicin will be assessed in an additional 20 patients for further safety, tolerability, and preliminary cardioprotective and anticancer efficacy signals.
Race said a recent meta-analysis of single-agent doxorubicin treatment undertaken has identified an anticancer response rate to doxorubicin of up to 35 per cent in a wide range of advance 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 identified enhancement of the cancer-killing activity of doxorubicin by the active anticancer agent in RC220 in 85 per cent of 143 diverse cancer cell lines screened.
Race CEO Dr Daniel Tillett said, “I am proud of the hard work and dedication from the Race clinical team, George Clinical and CCF in reaching this point. I look forward to soon treating the first patient with RC220 and beginning the process of advancing RC220 as a potential new treatment able to improve cancer therapy while protecting patients from the serious side effects of cancer treatment.”