A new clinical trial has started to test a potential treatment for a common type of lung cancer. Racura Oncology has given the first dose of a drug called RC220 to a patient with non-small cell lung cancer (NSCLC) that has a specific genetic mutation called EGFR. The patient received a low dose of RC220 (50mg/m²) mixed with the standard lung cancer drug osimertinib (Tagrisso) without any side effects. The trial is called HARNESS-1 and is being led by Associate Professor Surein Arulananda and his team at Monash Health in Victoria.
This study aims to find out if RC220 can be safely combined with osimertinib for patients whose cancer has stopped responding to osimertinib alone. Resistance to targeted therapies like osimertinib is a major challenge in treating this type of lung cancer.
The trial will start by testing small groups of patients with gradually increasing doses of RC220 (50mg/m², 100mg/m², and 150mg/m²) to determine the safest and most effective dose when combined with osimertinib. After this phase, larger groups of patients will be enrolled to further test the safety, how the drug moves through the body, and its effectiveness in slowing down or shrinking the cancer.
Daniel Tillett, CEO of Racura Oncology, shared his excitement about this milestone: ‘Starting the HARNESS-1 trial is a big step forward in developing RC220 as a possible new treatment. This trial focuses on patients who have developed resistance to current targeted therapies, which is a serious problem. We are very grateful to Associate Professor Surein Arulananda and his team at Monash Health for their hard work in recruiting and treating the first patient, and we thank the patients and their families for participating in this important research.’
The study will take place at multiple centers and will use blood tests to help identify suitable patients. Initially, 12 to 40 patients will be enrolled in the dose-escalation phase. Later, another 40 patients will join a randomized phase to further evaluate the safety, how the drug works in the body, and its effects on the cancer, including how long patients live without their cancer getting worse and their overall survival.