Race Oncology doses first patient in RC220 Phase 1 solid tumour trial
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First patient dosed at lead trial site, Southside Cancer Care.
Phase 1 trial to determine safety, tolerability and pharmacokinetic data, plus maximum tolerated combined dose of RC220 with chemotherapeutic doxorubicin.
Up to 33 patients to be recruited in first stage across sites in Australia, Hong Kong and South Korea.
Special Report: The first site in Race Oncology's Phase 1 clinical trial of RC220 in advanced solid tumours has been activated with the first patient dosed safely at Southside Cancer Care Centre in Miranda, NSW.
No vein inflammation or any other adverse events were reported, clearing the way for Race Oncology (ASX:RAC) to dose more patients in this first stage of the trial.
The company's goal is to establish the safety, tolerability and pharmacokinetic data – in other words, the way the drug is absorbed, distributed, metabolised and excreted – as well as the maximum tolerated combined dose of RC220 in combination with powerful chemotherapy drug doxorubicin.
A second trial site at the Gosford and Wyong hospitals also recently opened for patient enrolment, with up to another 32 patients to be enrolled at sites across Australia, Hong Kong and South Korea.
Race Oncology CEO Dr Daniel Tillet said the safe dosing of this first patient was a major milestone for the company, and the beginning of an important program that would assess the safety, tolerability and therapeutic potential of RC220.
'We are grateful to all the patients, investigators and clinical teams who have made this trial possible,' Tillet said.
'I would also like to thank our shareholders for their strong and loyal support that has enabled us to bring RC220 to patients in the clinic." Why combine chemotherapy with RC220?
RC220 is a small molecule drug found to enhance the cancer-killing activity of chemotherapy doxorubicin in 85% of 143 cancer cell lines screened by RAC.
The drug has been investigated in more than 50 clinical trials where it was found to have an effect in a range of solid and blood-based cancers including breast, ovarian, kidney, lung and various leukaemias including acute myeloid leukaemia.
Importantly, RC220 demonstrates an anti-cancer effect with less cardiotoxicity compared to chemotherapy anthracyclines like doxorubicin, therefore offering a potential cardioprotective effect that could reduce damage to the heart during chemotherapy treatments, while enhancing the drugs' cancer killing effect.
In Stage 2 of the trial, RAC will use an optimal dosage of RC220 in combination with doxorubicin – determined by an analysis of Phase 1 data – in 20 additional patients to establish further safety, tolerability, and preliminary cardioprotective and anticancer efficacy signals.
As the trial is open-label, patient outcomes will be available for assessment as soon as treatment is complete.
RAC intends to announce progress updated on a regular basis, but not on an individual patient level.
This article was developed in collaboration with Race Oncology, a Stockhead advertiser at the time of publishing.
This article does not constitute financial product advice. You should consider obtaining independent advice before making any financial decisions.
Originally published as Race Oncology doses first patient in RC220 Phase 1 solid tumour trial
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