Race Oncology (ASX:RAC) has announced that Bellberry has approved a phase one clinical trial of RC220 bisantrene alone and combined with doxorubicin in patients with solid tumours.
Race is initiating the trial in collaboration with the Cancer Care Foundation. The lead site, Southside Cancer Care Centre in Sydney, will be initiated under the supervision of principal investigator Dr Mahmood Alam.
The trial is an open-label, multi-centre, phase-one study and will be conducted in two stages.
Stage one will commence with a dose escalation of RC220. Up to 33 patients will be enrolled and receive an intravenous infusion of RC220 alone on day one before progressing to a combination treatment. Patients will receive intravenous RC220 followed by intravenous doxorubicin on a 21-day cycle. Dose escalation will use a Bayesian design until the maximum tolerated combined dose is reached.
Patients in the trial will continue to be treated until they reach either successful control of disease, disease progression, unacceptable toxicity, or withdrawal of consent.
Once the maximum tolerated combined dose has been determined, all accumulated safety and pharmacokinetic data will be analysed before initiation of stage two.
This expansion stage will recruit patients with solid tumours who have not previously been treated with doxorubicin or other anthracyclines. Patients will receive the optimal dosage of RC220 in combination with doxorubicin to confirm the safety of the combination and study a range of exploratory endpoints, including cardioprotection, anticancer, anti-aging and other clinical biomarkers, such as the effects of RC220 on the m6 A RNA regulatory system.
Race CEO and managing director Dr Daniel Tillett said, “Receiving human ethics approval for the first RC220 trial is a significant milestone for Race, in line with our vision to improve cancer patient treatment by developing new cardioprotective therapies with anticancer benefits. I wish to thank the Bellberry HREC and the entire Race and George Clinical teams for all their efforts, which enabled us to reach this critical milestone.”
Cancer Care Foundation founder, chair and CEO Dr Tony Noun added, “Congratulations to Race, to our Clinical Trial Director, Dr Alam, and our Cancer Care Foundation Team for helping to get us to this important milestone. Another step in our quest to improve outcomes for cancer patients.”