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

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.

Trial Details

NCT ID

NCT07197580

Phase

PHASE3

Sponsor

Telix Pharmaceuticals (Innovations) Pty Limited

Status

RECRUITING

Cancer Type

Kidney Cancer

Interventions

177Lu-TLX250

Locations (sample)

Sydney, New South Wales, Australia|-33.86785,151.20732
Wollongong, New South Wales, Australia|-34.424,150.89345
Heidelberg, Victoria, Australia|-37.75,145.06667
Melbourne N., Victoria, Australia
Murdoch, Washington, Australia|-32.06987,115.83757

Key Eligibility Criteria

be aged ≥ 18 years.
have provided written informed consent, dated and signed by the participant prior to any study-specific procedure;
have relapsed or recurrent, locally advanced, or metastatic RCC with histologically or cytologically confirmed diagnosis of RCC with clear cell com…
have received at least 2 and no more than 3 prior lines of systemic therapies for locally advanced or metastatic ccRCC including a PD-1/PD-L1 inhib…

For full eligibility, visit ClinicalTrials.gov.

Check If You May Be Eligible

Trialify translates complex eligibility criteria into plain yes-or-no questions to help you understand if this trial might be right for you.

Find Kidney Cancer Trials on Trialify →