Race Oncology Ltd (ASX:RAC, OTC:RAONF) has appointed leading global contract research organisation (CRO) George Clinical International to support the clinical development of RC220 bisantrene as a cardioprotective and anticancer treatment in solid tumour patients.
The decision follows an extensive selection process conducted by Race Oncology's clinical team.
“We are delighted George Clinical can support this significant step for Race and through the selection process their responsiveness and clinical insight has impressed us," Race chief medical officer Dr Michelle Rashford said.
“I and the rest of Race clinical team look forward to working with George Clinical on this and future trials.”
Targeting advanced solid tumours
The Phase 1a/1b trial will target cancer patients in Australia, Hong Kong and South Korea who have advanced solid tumours where doxorubicin treatment is indicated.
The company hopes the study will deliver human safety and pharmacokinetic data, determine optimal dosing in combination with doxorubicin and gather initial human results on the cardioprotective, anti-cancer and m6A RNA activity of RC220 bisantrene.
George Clinical was selected for its extensive trial experience and successful track record in conducting oncology trials across the United States, Europe, China, South-East Asia, New Zealand and Australia.
Additionally, George Clinical brings access to a network of key opinion leaders in clinical oncology, particularly those experienced in treating solid tumours with anthracyclines.
Two stages
The Phase 1 trial will be conducted in two stages across multiple sites. The Phase 1a stage will involve ascending doses of RC220 bisantrene to assess safety, tolerability, pharmacokinetics, m6A RNA effects and the maximum tolerated dose, both alone and in combination with doxorubicin.
In the Phase 1b stage, the optimal dosage of RC220 bisantrene in combination with doxorubicin will be evaluated for additional safety, tolerability and preliminary cardioprotective and anticancer efficacy signals.
The trial will employ a Bayesian design to enhance flexibility and speed. The final protocol and commencement of the trial are pending human ethics and institutional approvals.
Race Oncology has commenced engagement with George Clinical under a Start-Up Agreement (SUA) valued at A$1,071,067.
Further payments will be made under a master service agreement (MSA) as key milestones are achieved.
The estimated total cost of the Phase 1 trial is A$6 million, based on the recruitment of 34 patients, with additional costs for drug supply, pharmacokinetics and biomarker analysis.
This collaboration marks a significant step forward in the development of RC220 bisantrene, potentially offering a new treatment option for patients with advanced solid tumours.
"Significant milestone"
Race CEO Dr Daniel Tillett said: “This agreement with George Clinical is a significant milestone for Race to bring RC220 bisantrene to the clinic to potentially protect patients from the heart damage caused by anthracyclines while improving the treatment of their cancer.
“I welcome the opportunity for Race to work with George Clinical and wish to thank the Race clinical team for their hard work and dedication in reaching this agreement.”