Racura Oncology Treats First Patient in Harness-1 EGFRm Lung Cancer Trial

Racura Oncology (ASX: RAC) has dosed the first patient in Phase 1 of its Harness-1 multi-centre clinical trial of development drug RC220 to treat epidermal growth factor receptor (EGFR)-mutant non-small cell lung cancer (NSCLC).

The patient received an intravenous infusion of 50 milligrams per square metre RC220 by principal investigator associate professor Surein Arulananda and his team at Monash Health in Victoria, with no adverse events observed.

Racura’s trial is evaluating whether RC220 can be safely combined with the standard-of-care tyrosine kinase inhibitor (TKI) osimertinib (sold under brand names Tagrisso or AstraZeneca) in patients with this form of cancer for whom resistance to certain TKI treatments remains a significant clinical challenge.

It includes an observational (screening) stage that uses circulating tumour DNA (ctDNA) — a blood-based marker of cancer activity and growth — to help identify and enrol up to 40 eligible patients for treatment.

Staged Trial Approach

The trial will use single-patient cohorts for the first three dose escalations (50mg/m2, 100mg/m2 and 150mg/m2), before progressing to larger cohorts to identify the maximum tolerated dose (MTD) of RC220 in combination with osimertinib.

This staged approach is designed to support careful dose escalation while generating early safety and pharmacokinetic (PK) data including progression-free survival, overall survival, and changes in cancer-specific mutations.

The study will then move into a double-blind, randomised Phase 1b expansion stage in which patients will continue treatment with RC220 and osimertinib until one year of treatment is completed or if disease progression, unacceptable toxicity, or withdrawal of consent occurs.

Racura’s lead asset (E,E)-bisantrene is a small molecule anti-cancer agent designed to silence cancer growth pathways through G4-DNA and RNA binding, including the cancer growth regulator MYC.

(E,E)-bisantrene has previously demonstrated therapeutic activity in cancer patients and has a well-characterised safety profile.

Important Step for RC220

RC220 is a proprietary formulation of (E,E)-bisantrene for multiple oncology indications and its current clinical programs include a Phase 3 trial into acute myeloid leukaemia and a Phase 1a/b trial in combination with doxorubicin chemotherapy medication for solid tumour patients.

Racura chief executive officer Dr Daniel Tillett said treatment of the first patient was an important step in RC220’s clinical development.

“This trial is focused on a patient group where resistance to current targeted therapies remains a significant challenge,” he said.

“We are grateful to the team at Monash Health for their work in recruiting and treating the study’s first participant, and we thank the patients and families supporting this clinical research.”