Race Oncology Ltd (ASX:RAC) has received human ethics approval to begin its HARNESS-1 Phase 1a/b lung cancer trial of RC220 in combination with osimertinib.
The St Vincent’s Hospital Melbourne Human Research Ethics Committee (HREC) has cleared the study, which will investigate the safety, tolerability and pharmacokinetics of RC220 (E,E-bisantrene, RCDS1) alongside osimertinib (Tagrisso®; AstraZeneca) in adult patients with non-small cell lung cancer (NSCLC) harbouring activating epidermal growth factor receptor mutations (EGFRm).
“Obtaining human ethics approval for this second study of RC220 is another major achievement for Race. In this trial we aim to address the significant unmet medical need for better treatments for patients who develop resistance to third-generation EGFRm NSCLC tyrosine kinase inhibitors," Race Oncology CEO and managing director Dr Daniel Tillett said. "I wish to thank the St Vincents Hospital Melbourne HREC, the St Vincents Research Valet Service, and the entire Race and Beyond Drug Development teams for their efforts and dedication.”
Monash Health greenlit to enrol patients
Ethics approval allows the lead site, Monash Health in Clayton, Victoria, to begin enrolling patients once final institutional approval and site activation are complete. Overseeing enrolment is Principal Investigator Dr Surein Arulananda, with the support of Beyond Drug Development.
First patient enrolment is expected in late Q4 2025 or early Q1 2026. Race expects four additional clinical trial sites to be activated in the coming months, making HARNESS-1 a multi-centre study.
The Phase 1a/b trial will use circulating tumour DNA (ctDNA) to screen and enrol EGFRm NSCLC patients already receiving standard-of-care osimertinib. Phase 1a will begin with a ctDNA screening stage followed by dose escalation of RC220. Between 12 and 40 patients are expected to receive intravenous RC220 on Day 1 of a 21-day cycle in combination with osimertinib. The Bayesian dose-escalation design will start with three single-patient cohorts before progressing to larger cohorts to determine the maximum tolerated dose (MTD) of RC220.
Patients will remain on combination treatment with RC220 and osimertinib until one of several endpoints is reached:
- successful control of disease
- completion of one year of treatment
- disease progression
- unacceptable toxicity or withdrawal of consent.
Assessment followed by double blind stage
Once the MTD has been established, accumulated safety and pharmacokinetic data will be assessed ahead of starting the double-blind, randomised Phase 1b dose-expansion stage. In Phase 1b, 40 patients will be randomised to one of two RC220 dose levels. In addition to monitoring safety and PK, the study will evaluate a range of secondary and exploratory endpoints, including progression-free survival, overall survival, changes in ctDNA levels and changes in the cancer-specific mutations present in patients.