Racura Oncology (ASX: RAC) has achieved a significant milestone with the governance approval of its HARNESS-1 Phase 1a/b trial for RC220 in combination with osimertinib, targeting EGFR-mutant non-small cell lung cancer (NSCLC).
This critical step clears the path for site initiation and patient recruitment in the lung cancer program.
Monash Health has granted governance approval for the trial, which targets EGFR-mutant NSCLC and aims to address resistance to osimertinib.
Site initiation training is scheduled for March 23, 2026, with first patient recruitment anticipated shortly thereafter.
Four additional trial sites are planned for activation.
RC220 Trial Design and Scope
The trial will employ ctDNA screening and an accelerated single-patient dose escalation cohort, enrolling between 12 and 40 patients.
A Bayesian dose escalation will determine the maximum tolerated dose, followed by a Phase 1b expansion cohort of up to 40 patients.
RC220 is described as an RNA/DNA G4 binder, intended to enhance efficacy and safety in combination therapy.
This advancement follows the company's recent December 2025 quarterly report, highlighting expanded RC220 clinical programmes in NSCLC and acute myeloid leukaemia.
A prior collaboration with Emory University aimed to study RC220 in osimertinib-resistant NSCLC, strengthening preclinical understanding.
Racura is also developing a cardioprotection blood test for use in its RAC-010 CPACS trial, aiming for earlier readouts.
Funding and Strategic Position
The company ended the December 2025 quarter with $20.94 million in cash, providing a runway through CY2027.
Previous funding was secured via a private placement and option conversions.
Intellectual property filings for the (E,E)-bisantrene isoform offer potential for up to 20 years of protection.
The HARNESS-1 trial approval represents a key operational step for Racura Oncology, advancing its lead candidate RC220 into human trials for a significant unmet need in lung cancer.
While early-stage risks remain, the company's sustained funding and expanding research collaborations provide a supportive backdrop for clinical development.
