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FDA Approves Phase II Kidney Cancer Therapy Study
2021/10/07

In another news involving the firm Telix, it announced that the United States Food and Drug Administration (FDA) has accepted the Investigational New Drug (IND) Application to undertake a clinical study of its 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 clear cell renal cell carcinoma (ccRCC), the most common and aggressive form of kidney cancer. TLX250 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. The study will evaluate TLX250-delivered radiation as an immune system “primer” in combination with the anti-PD-1 immunotherapy Opdivo® (nivolumab). The primary endpoint is to determine the efficacy of combining immunotherapy with TLX250 as assessed by the number of tumors responding to the Telix therapy versus the current standard of care alone. The study is expected to enroll 29 patients.

                                 

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FDA Approves Phase II Kidney Cancer Therapy Study

Source: TELIX