Clinical Trial

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

Study acronym: LUTEON
Recruiting Phase 3
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Summary
Multicenter Phase 3 study of 177Lu-TLX250 in adult participants with CAIX-expressing advanced, relapsed or recurrent clear cell renal cell carcinoma (ccRCC). Part 1 will evaluate two dosing regimens to determine the recommended Phase 3 dose (RP3D). Part 2 will compare 177Lu-TLX250 with investigator's choice of monotherapy aligned with Australian standard-of-care.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-09-22.
Status change: Not Yet Recruiting → Recruiting 2026-03-26
Trial Details
NCT Number NCT07197580
Lead Sponsor Telix Pharmaceuticals (Innovations) Pty Limited
Collaborators: Medpace, Inc.
Conditions ccRCC, Renal Cell Carcinoma (Kidney Cancer), Renal Cell Carcinoma (RCC), Renal Cell Cancer Metastatic, Renal Cell Cancer, Recurrent, Clear Cell Renal Cell Cancer (ccRCC)
Enrollment 40 participants
Start Date 2026-03-25
Primary Completion 2027-08-31 (estimated)
Study Completion 2029-02-28 (estimated)
Updated on ClinicalTrials.gov 2026-04-01