Key Takeaways
- Racura Oncology has initiated Phase 1 of the Harness-1 trial for RC220, targeting EGFR-mutant non-small cell lung cancer (NSCLC).
- The first patient has been dosed at Monash Health with no adverse effects observed during the infusion of 50 mg/m² of RC220.
- The trial aims to evaluate the combination of RC220 with osimertinib in treating patients resistant to standard TKI therapies.
Trial Initiation and Objectives
Racura Oncology (ASX: RAC) has officially launched its Phase 1 clinical trial, Harness-1, to investigate RC220, a treatment for epidermal growth factor receptor (EGFR)-mutant non-small cell lung cancer (NSCLC). The first patient was administered an intravenous infusion of 50 milligrams per square meter of RC220 under the guidance of associate professor Surein Arulananda and his team at Monash Health, Victoria. Encouragingly, no adverse events were noted post-infusion.
The primary goal of the trial is to determine if RC220 can safely be paired with the standard tyrosine kinase inhibitor (TKI), osimertinib (known as Tagrisso). This combination aims to address the significant clinical issue of resistance faced by patients undergoing TKI treatments for this type of cancer. An observational stage of the trial will utilize circulating tumor DNA (ctDNA), a blood marker indicative of cancer presence and progression, to screen and enroll up to 40 eligible patients.
Staged Trial Design
The trial employs a staged approach, starting with single-patient cohorts during the first three dose escalations (50 mg/m², 100 mg/m², and 150 mg/m²) before advancing to larger groups to establish the maximum tolerated dose (MTD) of RC220 in conjunction with osimertinib. This method ensures careful dose escalation while collecting crucial safety and pharmacokinetic data, including metrics such as progression-free survival, overall survival, and variations in cancer-specific mutations.
Subsequently, the study will transition into a Phase 1b expansion stage, which is double-blind and randomized. Patients will continue receiving treatment with RC220 alongside osimertinib for up to a year or until disease progression, intolerable side effects, or withdrawal occurs.
Significance of RC220
RC220 is a proprietary version of (E,E)-bisantrene, designed for various cancer applications. Current clinical programs include a Phase 3 trial focusing on acute myeloid leukemia and a Phase 1a/b study evaluating its use with doxorubicin for solid tumors. Dr. Daniel Tillett, Racura’s CEO, emphasized the importance of beginning this trial, particularly for a patient demographic that struggles with resistance to existing targeted therapies. He expressed gratitude towards the Monash Health team for their dedication to the trial and the participants supporting this crucial research.
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