Race Oncology has received the St Vincents Hospital Melbourne Human Research Ethics Committee (HREC) approval to begin a Phase 1a/b trial of RC220 (E,Ebisantrene, RCDS1) for lung cancer.
The multi-centre trial will evaluate the pharmacokinetics (PK), safety and tolerability of RC220 in combination with AstraZenica’s osimertinib for non-small cell lung cancer (NSCLC) patients with activating epidermal growth factor receptor mutations (EGFRm).
It will be conducted at the Monash Health clinical site under principal investigator Dr Surein Arulananda, with patient enrolment expected to start between late Q4 2025 and early Q1 2026, pending final institutional approval and site activation.
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The trial will screen participants using circulating tumour DNA (ctDNA).
Phase 1a will begin with a ctDNA screening stage followed by RC220 dose escalation where intravenous RC220 alongside standard-of-care care osimertinib will be administered to 12 to 40 participants.
The study will start with three single-subject groups, progressing to larger cohorts to identify the maximum tolerated dose (MTD).
Patients will continue to receive RC220 and osimertanib until they reach any of these outcomes: one year of treatment, disease progression, disease control, consent withdrawal, or toxicity.
Upon establishing the MTD, pharmacokinetic and safety data will be assessed before the randomised, double-blind Phase Ib dose expansion stage involving 40 participants assigned to two dose levels.
This phase will further monitor PK, safety, overall survival, progression free survival, cancer-specific mutation variations, and changes in ctDNA levels.
Race Oncology principal scientist Dr Rodney Cusack said: “The mechanism of action of (E,E)-bisantrene as a G-quadruplex binder promises to address key pathways of resistance identified in EGFR mutated NSCLC.
“This human ethics approval now enables Race to open a clinical trial in patients with EGFR mutated NSCLC and who have progressed or who are at risk of progressing while on treatment, setting the drug up to make a significant impact in this patient population.”
In June 2024, Race Oncology engaged contract research organisation (CRO) George Clinical International to support the Phase I clinical trial of RC220 Bisantrene targeting solid tumour patients.
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