RecruitingPhase 3NCT07197580

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

A Phase 3, Randomized, Multi-Center, Open-Label Study to Compare 177Lu-TLX250 (Lutetium (177Lu) Girentuximab Tetraxetan) With the Investigator's Choice of a Single Agent Therapy in Participants With Carbonic Anhydrase 9 (CAIX) Expressing, Advanced Relapsed or Recurrent Clear Cell Renal Cell Carcinoma (ccRCC)

Sponsor

Telix Pharmaceuticals (Innovations) Pty Limited

Enrollment

40 participants

Start Date

Mar 25, 2026

Study Type

INTERVENTIONAL

Conditions

Renal Cell Carcinoma (Kidney Cancer)Renal Cell Carcinoma (RCC)Renal Cell Cancer, Recurrent Clear Cell Renal Cell Cancer (ccRCC)ccRCC Renal Cell Cancer Metastatic

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying 177Lu-TLX250 for people with clear cell renal cell cancer (ccrcc), renal cell cancer metastatic, and other related conditions. The study is currently recruiting participants at 5 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATION177Lu-TLX250

3 infusions of 177Lu-TLX250 at 8-week intervals or 6 infusions 177Lu-TLX250 at 4-week intervals

Locations(5)

Westmead Hospital

Sydney, New South Wales, Australia

Wollongong Hospital

Wollongong, New South Wales, Australia

Austin Health

Heidelberg, Victoria, Australia

Melbourne Theranostic Innovation Centre (MTIC)

Melbourne N., Victoria, Australia

GenesisCare, Fiona Stanley Hospital (Murdoch)

Murdoch, Washington, Australia

View Full Details on ClinicalTrials.gov

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NCT07197580

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