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Radiopharm Theranostics Ltd (ASX:RAD) has received approval from the Australian Ethics Committee to expand its trial to assess the safety and tolerability of its antibody Lu-RAD204, meaning the treatment will be assessed with regard to five more tumour types.
The main function of RAD204 – a single domain monoclonal antibody – is its targeting of PD-L1, a protein which helps control the immune system and is overexpressed in many solid cancers.
Radiopharm has been progressing a Phase 1 clinical trial to assess how Lu-labelled RAD204 is tolerated for the treatment of PD-L1 expressing cancers, and as per the approval notice, this will now include participants with Programmed Death-Ligand 1 (PD-L1) positive Small Cell Lung Cancer (SCLC), Triple Negative Breast Cancer (TNBC), Melanoma, Head and Neck Cancer (HNSCC), and Endometrial Cancer.
The original focus of the trial was on participants with Non Small Cell Lung Cancer (NSCLC).
Recruitment is ongoing at four locations in New South Wales, South Australia, and Western Australia, with this being supported by oncology care provider GenesisCare CRO.
Positive indications have already been yielded from Phase I imaging data of 16 patients with NSCLC, showing that RAD204 is safe and is associated with acceptable dosimetry.
Radiopharm CEO and managing director Riccardo Canevari said being able to extend the trial to other cancers was significant.
“The implications of including additional PD-L1 expressing tumor types beyond NSCLC in this study is far-reaching,” he said.
“Patients with five additional PD-L1 expressing tumor types are now eligible for this basket trial, supporting the potential of 177Lu-RAD204 for a tumor-agnostic indication and as an effective radioimmunotherapy based on a pan-tumor predictive biomarker.
“With RAD204, we hope to provide an alternative strategy that can improve clinical outcomes for patients with PD-L1 positive advanced cancers, while potentially preserving their quality of life.”
At 14:46 AEDT, Radiopharm was trading at 2.7 cents – a rise of 3.85% since the market opened.
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