Telix Pharmaceuticals Limited announced that the United States Food and Drug Administration (FDA) has accepted the Investigational New Drug Application ("IND") to undertake a clinical study of the Company's investigational kidney cancer therapy, TLX250 (177Lu-DOTA- girentuximab). The STARLITE 2 study is a single arm, investigator-led Phase II study in patients with advanced lear cell renal cell carcinoma (ccRCC), the most common and aggressive form of kidney cancer. LX250 targets carbonic anhydrase IX (CA9), a protein that is highly expressed in patients that are likely to demonstrate a more limited response to cancer immunotherapy.1 The study will evaluate LX250-delivered radiation as an immune system "primer" in combination with the anti-PD-1 2 mmunotherapy Opdivo® 3 (nivolumab). The primary endpoint is to determine the efficacy of combining immunotherapy with TLX250 as assessed by the number of tumours responding to the elix therapy versus the current standard of care alone. The study is expected to enrol 29 patients.