Race Initiates First AU Site for Phase 1 Solid Tumour Trial
Released
Released
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ASX Announcement
Race Initiates First Australian Clinical Site for Phase 1 Solid
Tumour Trial
● Lead Australian trial site, Southside Cancer Care Centre in Miranda, NSW, is the first
site to be initiated for Race’s clinical trial of RC220 in advanced solid tumours
● Race is awaiting governance approval to activate the site for patient recruitment
● Up to 53 patients will be enrolled in the open-label study across multiple sites in
Australia, Hong Kong and South Korea
● Study will evaluate safety and pharmacokinetics, determine the maximum tolerated
combined dose of RC220 with doxorubicin, and provide initial clinical data on the
cardioprotective, anticancer and m 6A RNA activity of RC220
27 March 2025 – Race Oncology Limited (‘Race’) is pleased to announce the initiation of Southside Cancer
Care Centre in Miranda, NSW, in preparation for the commencement of patient enrolment for its Phase 1
clinical trial of RC220 in combination with doxorubicin in advanced solid tumours patients. Site initiation
follows the receipt of ethics approval for the trial this month (ASX Announcement: 14 March 2025) and
Race now awaits governance approval as the final step to activate the site for commencing patient
recruitment to the trial.
The Phase 1 trial is a two-stage open-label study to be conducted across multiple sites in Australia, Hong
Kong and South Korea. The trial will investigate ascending doses of RC220 to determine the safety,
tolerability, pharmacokinetics, maximum tolerated combined dose (MTCD) with doxorubicin, and effects
on a range of clinical biomarkers including m6A RNA.
After interim analysis of the data from Stage 1 of the trial, the optimal dosage of RC220 in combination
with doxorubicin will be assessed in additional patients for further safety, tolerability, cardioprotective
and anticancer efficacy signals. The Phase 1 trial will use a Bayesian design enabling greater trial flexibility
and speed than other approaches.
Race Chief Executive Officer, Dr Daniel Tillett comments: “We are pleased to have reached the milestone
of our first clinical site initiation in preparation for patient enrolment as soon as we receive governance
approval. Southside Cancer Care Centre serves as our lead trial site in Australia. Initiation of our lead site
moves us closer to launching our Phase 1 trial and, ultimately to our mission of providing new hope for
those fighting cancer.”
This trial is open label in nature, so patient outcomes are obtained soon after patients are treated. Race
will announce progress updates on the trial on a regular basis, but not at the individual patient level.
-ENDS-
Race Oncology Ltd • ABN 61 149 318 749
L36, 1 Macquarie Place Sydney NSW 2000 • T. +61 2 8051 3043 • E. info@raceoncology.com • www.raceoncology.com
About Race Oncology (ASX: RAC)
Race Oncology (ASX: RAC) is an ASX-listed clinical stage biopharmaceutical company with a dedicated
mission to be at the heart of cancer care.
Race’s lead asset, bisantrene, is a small molecule chemotherapeutic. Bisantrene has a rich and unique
clinical history with demonstrated therapeutic benefits in both adult and paediatric patients, a well
characterised safety profile, and compelling clinical data demonstrating an anticancer effect and less
cardiotoxicity over certain anthracyclines, such as doxorubicin.
Race is advancing a reformulated bisantrene (RC220) to address the high unmet needs of patients across
multiple oncology indications, with a clinical focus on anthracycline combinations, where we hope to
deliver cardioprotection and enhanced anti-cancer activity in solid tumours. Race is also exploring RC220
as a low intensity treatment for acute myeloid leukaemia.
Race is investigating the effect of bisantrene on the m 6A RNA pathway, following independent research
published by the City of Hope identifying bisantrene as a potent inhibitor of FTO (Fat mass and obesityassociated protein). Dysregulation of the m6A RNA pathway has been described in numerous peer
reviewed studies as a driver of a diverse range of cancers.
Race Oncology has collaborated with Astex, City of Hope, MD Anderson, Sheba City of Health, UNC School
of Medicine, University of Wollongong and University of Newcastle, and is actively exploring partnerships,
licence agreements or a commercial merger and acquisition to accelerate access to bisantrene for patients
with cancer across the world.
Learn more at www.raceoncology.com.
If you have any questions on this announcement or any past Race Oncology announcements, please go to
the Interactive Announcements page in our Investor Hub https://announcements.raceoncology.com
Race encourages all investors to go paperless by registering their details with the Company’s share registry,
Automic Registry Services, at www.automicgroup.com.au.
Release authorised by:
Media contact:
Daniel Tillett, CEO
info@raceoncology.com
Jane Lowe +61 411 117 774
jane.lowe@irdepartment.com.au
Race Oncology Ltd • ABN 61 149 318 749
L36, 1 Macquarie Place Sydney NSW 2000 • T. +61 2 8051 3043 • E. info@raceoncology.com • www.raceoncology.com
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