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Highlights
- Site initiation visit has been completed for RAD 204 therapeutic Phase 1 trial at Princess Alexandra Hospital in Brisbane.
- The trial is planned to open on 4 January 2024, and the first patient is expected to be dosed in January 2024.
- Patient pre-screening has started, marking a key milestone for the trial.
Radiopharm Theranostics Limited (ASX: RAD) has completed the site initiation visit (SIV) for the RAD 204 therapeutic Phase 1 study.
The title of the study is-
Data source: Company update
The study is the First-In-Human dose escalation trial of 177Lu-RAD 204, aimed at evaluating the safety and efficacy of 177Lu-RAD 204 in patients with advanced Non-Small Cell Lung Cancer (NSCLC). NSCLC is one of the most frequently occurring forms of lung cancer.
As per the American Cancer Society, by the end of 2023, around 300,000 new lung cancer cases will be identified in the US, of which 81% are expected to be NSCLC patients.
The trial, to be conducted at Princess Alexandra Hospital in Brisbane, Australia, will be supported by GenesisCare, an oncology care provider.
More
The study will be performed in 21 patients with PD-L1-positive NSCLC. The company informed that Phase 1 imaging study in 16 patients has been completed, confirming safety and biodistribution.
The technology supporting the study is RAD’s proprietary nanobody from its NanoMabs platform. The technology targets programmed death-ligand 1 (PD-L1) – positive expression in NSCLC.
Presently, pre-screening of eligible NSCLC patients is underway, marking a significant milestone for the trial preparation. This development confirms the commitment and readiness to dose patients with 177Lu-RAD 204.
The study will be formally activated on 4 January 2024, and the first patient is expected to be dosed in January 2024.
RAD shares closed at AU$0.073 apiece on 27 December 2023.
