Race Oncology Ltd will soon begin a Phase 1 trial for RC220 in combination with doxorubicin after the Human Research Ethics Committee (HREC) approved the trial to begin at the Gosford and Wyong Hospitals within the Central Coast Local Health District in Australia.
Subject to final site approvals and activations, the two hospitals will begin enrolling patients during the month of April.
The clinical trial, dubbed RAC-010, has been designed to assess the tolerability, safety and pharmacokinetics of RC220 alone and in combination with doxorubicin in patients with solid tumours.
Race is advancing a reformulated anti-cancer drug, bisantrene (RC220), to address the high unmet needs of patients across multiple oncology indications, with a clinical focus on anthracycline combinations, where the company hopes to deliver cardio-protection and enhanced anticancer activity in solid tumours.
Milestone a testament to team’s dedication
“Receiving our second human ethics approval for our RC220 trial so soon after our first approval is both highly encouraging and a testament to the dedication of the team at Race,” Race Oncology CEO and managing director Dr Daniel Tillett said.
“Once again, I wish to thank the Bellberry HREC and the entire Race and George Clinical teams for all their efforts in reaching this milestone.”
The approval follows a similar green light for the Southside Cancer Centre in Miranda, and RAC expects to receive more ethics approvals for additional sites in Australia, Hong Kong and South Korea in the coming months.
The company expects to activate most Australian sites in the first or second quarters of 2025, with Hong Kong and South Korean sites to follow in the third quarter.
“This second ethics approval provides Race with further momentum for the study and in bringing RC220 to cancer patients,” Race Oncology chief medical officer Dr Michelle Rashford said.