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ASCO 2025 | STARLITE-1: 177Lu-Girentuximab, cabozantinib & nivolumab in ccRCC

Eric Jonasch, MD, The University of Texas MD Anderson Cancer Center, Houston, TX, describes the Phase Ib/II STARLITE-1 trial (NCT05533242) of 177Lu-Girentuximab with cabozantinib and nivolumab in treatment-naïve patients with advanced clear cell renal cell carcinoma (ccRCC). This triplet regimen aims to enhance complete response rates through synergy between targeted radiotherapy and immunotherapy. Key endpoints include safety and complete response rate. This interview took place during the 2025 American Society of Clinical Oncology (ASCO) Meeting in Chicago, IL.

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Transcript

Yeah, so the STARLITE-1 study is a combination of lutetium girentuximab. So this is an antibody against G250, which is tagged to lutetium, plus cabozantinib and nivolumab in individuals with previously untreated clear cell renal cell carcinoma. The hypothesis is that by using radiation doses that are delivered to the tumor, that you irritate the tumor in a way that you upregulate things like STING signaling, increase immune ingress into the microenvironment and you enhance immune efficacy...

Yeah, so the STARLITE-1 study is a combination of lutetium girentuximab. So this is an antibody against G250, which is tagged to lutetium, plus cabozantinib and nivolumab in individuals with previously untreated clear cell renal cell carcinoma. The hypothesis is that by using radiation doses that are delivered to the tumor, that you irritate the tumor in a way that you upregulate things like STING signaling, increase immune ingress into the microenvironment and you enhance immune efficacy. This study will be accruing patients very soon. We don’t have any clinical data yet, but we’re very excited to see. This is a very tissue-rich and data-rich study, so we’re going to either way learn something from this trial, whether or not this is a reasonable strategy.

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Disclosures

Consulting or Advisory Role – Aveo; Eisai; Exelixis; GlaxoSmithKline; Ipsen; Merck; NiKang Therapeutics; Novartis; Takeda; Telix Pharmaceuticals
Research Funding – Abbvie (Inst); Arrowhead Pharmaceuticals (Inst); Aveo (Inst); Corvus Pharmaceuticals (Inst); Merck (Inst); NiKang Therapeutics (Inst); ProfoundBio (Inst); Telix Pharmaceuticals (Inst)
Travel, Accommodations, Expenses – Pfizer