Radiopharm Theranostics Ltd (ASX:RAD, OTC:RDPTF) has completed a site initiation visit (SIV) for its RAD 204 Phase 1 study, designed to evaluate the safety and efficacy of this novel radiotherapeutic in eligible individuals with advanced non-small cell lung cancer (NSCLC), the most common type of lung cancer.
The technology underpinning the trial is the company's proprietary nanobody from its NanoMabs platform, which targets programmed deathligand 1 (PD-L1)-positive expression in NSCLC.
The study will be conducted at Princess Alexandra Hospital in Brisbane, Australia, with the support of leading oncology care provider GenesisCare.
Lu-RAD 204 will be formally activated on January 4, 2024 with the first patient expected to be dosed in January 2024.
"Game changer"
Radiopharm CEO and managing director Riccardo Canevari said: “Approximately 300,000 new lung cancer cases will be diagnosed in the US by the end of 2023, 81% of which are estimated to be NSCLC patients1.
“Despite the major progress in advancing anti-PD1/PD-L1 immunotherapy agents for eligible NSCLC patients, we are still struggling to understand how to treat them once they become refractory to these agents.
"We are highly encouraged by the initial findings from the preclinical studies and Phase 1 imaging data in humans for 177Lu-RAD 204, and as such, we believe this radiotherapeutic agent may be a game changer, as monotherapy or in combination, for the treatment of advanced NSCLC.
"We look forward to continuing our progress and conducting this study, with results expected in early 2025.”
More about the study
This is a Phase 1 first-in-human study involving 21 patients, designed to evaluate safety and efficacy of 177Lu-RAD 204 in PD-L1-positive NSCLC.
A Phase 1 imaging study has been completed in 16 patients confirming safety and biodistribution.
A key milestone was achieved for RAD 204's clinical trial preparation with patient pre-screening started.