Trial Profile

Phase 1b/2 Study of Combination 177Lu Girentuximab Plus Cabozantinib and Nivolumab in Treatment naïve Patients With Advanced Clear Cell RCC

Status: Recruiting

Phase of Trial: Phase I/II

Latest Information Update: 07 May 2026

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At a glance

Drugs 18F-F-AraG (Primary) ; Cabozantinib (Primary) ; Lutetium-177-DOTA-girentuximab (Primary) ; Nivolumab (Primary)
Indications Renal cell carcinoma
Focus Adverse reactions; Therapeutic Use
Acronyms STARLITE-1

Most Recent Events

14 Oct 2025 According to the Telix Pharmaceutical media release, this trial has commenced dosing patients.
06 Oct 2025 Planned primary completion date changed from 30 Oct 2025 to 30 Oct 2027.
22 Jul 2025 According to the Telix Japan media release, trial submission is in preparation for a pivotal trial of TLX250 as a monotherapy in advanced metastatic ccRCC, initially launching ex-U.S.

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