Race Oncology has engaged contract research organisation (CRO) George Clinical International to support the Phase I clinical trial of RC220 Bisantrene targeting solid tumour patients.
With capabilities in conducting clinical trials, George Clinical will offer access to a supplementary network of clinical oncologists with expertise in treating solid tumours with anthracyclines.
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These specialists will aid Race in refining and conducting the Phase I trial of RC220 intravenous bisantrene administered peripherally along with a standard-of-care (SOC) regimen comprising doxorubicin (Adriamycin) in advanced solid tumour patients.
The trial will be executed under an open-label model in two stages across various sites in Australia, Hong Kong and South Korea.
The Phase 1a portion of the study will assess ascending doses of RC220 bisantrene to evaluate the tolerability, safety and efficacy.
In the Phase 1b stage, RC220 bisantrene’s optimal dosage, along with doxorubicin, will be evaluated further for safety, tolerability, and initial cardioprotective and anticancer efficacy signals.
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By GlobalDataThe engagement of George Clinical was executed under a start-up agreement valued at $1.07m, with additional payments to be made throughout the study based on key milestones and patient recruitment.
The estimated cost for the CRO services in the Phase I trial is around $6m, assuming the recruitment of 34 patients.
This figure does not include additional costs for drug supply, pharmacokinetics and biomarker analysis.
The trial protocol and commencement are subject to receipt of necessary human ethics and institutional approvals.
Race chief medical officer Dr Michelle Rashford said: “This is a key foundational study to establish important safety and drug absorption kinetics for RC220 and provide appropriate doses for effective combination with doxorubicin to advance the development of RC220 for clinical cardiac benefit to patients treated with anthracyclines while providing improved outcomes.
“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.”
