STARLITE 1: Phase 1b/2 Study of Combined 177Lu-Girentuximab plus Cabozantinib and Nivolumab in Treatment-naïve Patients with Advanced Clear-cell Renal Cell Carcinoma

Elshad Hasanov; Lesley Flynt; Rebecca Slack Tidwell; Hyunsoo Hwang; Roserika Brooks; Lauren Michelle Wood; Travis Solley; Mashaal Syed; Aradhana M Venkatesan; Eric Jonasch

doi:10.1016/j.euf.2025.04.003

STARLITE 1: Phase 1b/2 Study of Combined ¹⁷⁷Lu-Girentuximab plus Cabozantinib and Nivolumab in Treatment-naïve Patients with Advanced Clear-cell Renal Cell Carcinoma

Eur Urol Focus. 2025 Apr 26:S2405-4569(25)00077-X. doi: 10.1016/j.euf.2025.04.003. Online ahead of print.

Authors

Affiliations

¹ Division of Medical Oncology, Pelotonia Institute for Immuno-Oncology, Ohio State University Comprehensive Cancer Center, Ohio State University Wexner Medical Center, Columbus, OH, USA.
² Department of Nuclear Medicine, University of Texas MD Anderson Cancer Center, Houston, TX, USA.
³ Department of Biostatistics, University of Texas MD Anderson Cancer Center, Houston, TX, USA.
⁴ Department of Genitourinary Medical Oncology, University of Texas MD Anderson Cancer Center, Houston, TX, USA.
⁵ Department of Abdominal Imaging, University of Texas MD Anderson Cancer Center, Houston, TX, USA.
⁶ Department of Genitourinary Medical Oncology, University of Texas MD Anderson Cancer Center, Houston, TX, USA. Electronic address: ejonasch@mdanderson.org.

PMID: 40288950
DOI: 10.1016/j.euf.2025.04.003

Abstract

This trial is evaluating the combination of ¹⁷⁷Lu-girentuximab with nivolumab and cabozantinib to enhance the complete response rate in advanced clear-cell renal cell carcinoma (ccRCC). The aim is to activate cGAS-STING-induced antitumor immunity via targeted radioimmunotherapy damage to DNA. If successful, this approach could establish a novel paradigm that combines radiopharmaceuticals with immunotherapy and targeted therapy in ccRCC.