Phase 3 Study Comparing 177Lu-TLX250 Radioligand Therapy to Standard Single-Agent Treatment in Adults with Advanced or Recurrent Clear Cell Renal Cell Carcinoma Expressing CAIX

What this Trial Is About

Researchers are evaluating the safety and effectiveness of 177Lu-TLX250, a targeted radioligand therapy, in adults with advanced, relapsed, or recurrent clear cell renal cell carcinoma ccRCC that expresses the CAIX protein. This Phase 3, randomized, open-label study aims to find the best dosing regimen and compare 177Lu-TLX250 to standard single-agent therapies used in Australia. The study includes participants who have previously received multiple systemic treatments and have measurable disease progression. The study has two parts Part 1 focuses on dose optimization by randomly assigning participants to receive either three infusions of 177Lu-TLX250 at 8-week intervals or six infusions at 4-week intervals. Part 2 compares the chosen dose of 177Lu-TLX250 with the investigators choice of a single standard therapy. Treatments are given intravenously, and the study evaluates different dosing schedules over several months. Participants will undergo various assessments including imaging scans, laboratory tests, and quality of life questionnaires throughout the study, which lasts about two years. Researchers will monitor safety, treatment response, survival, and how the drug distributes in the body. They will also evaluate side effects, immune responses, and radiation exposure. This comprehensive monitoring helps understand the therapys impact and tolerability over time.

Phase 3 Study to Assess Safety and Efficacy of 177Lu-TLX250 in Advanced Relapsed or Recurrent ccRCC