Recruiting

Testing a new radioactive treatment for advanced kidney cancer

Plain-English translation of NCT07197580 on ClinicalTrials.gov ↗ · Source last updated April 2026 · Translation generated June 2026 · How we translate trials

Phase 3 — Testing in thousands of people, comparing the treatment against what doctors currently use. This is the last big step before approval.

What is this trial?

This study is testing a new radioactive medication called 177Lu-TLX250 (lutetium girentuximab tetraxetan) in people with advanced clear cell renal cell carcinoma—a type of kidney cancer that has come back or spread despite previous treatments. The medication is designed to target cancer cells that express a specific protein called CAIX. Researchers will compare this new treatment to other standard single-agent therapies that your doctor would normally choose.

People with advanced kidney cancer that has recurred or progressed despite at least two prior treatment lines often have limited options and poor outcomes. This medication represents a new approach using radioactive molecules to directly target cancer cells, and researchers want to see if it can help patients live longer and have fewer side effects than currently available options.

Do you qualify?

You likely qualify if…

you are 18 years or older
you have been diagnosed with clear cell renal cell carcinoma that is advanced, has returned, or has spread to other parts of your body
you have received at least 2 but no more than 3 prior lines of systemic therapy, including an immunotherapy drug and a targeted therapy
your cancer has grown or worsened during or after your most recent treatment, or you could not tolerate the treatment
you have at least one measurable tumor lesion that your doctor can track
your cancer cells test positive for the CAIX protein (confirmed by a special scan)
you have a good overall health status (ECOG performance status of 0 or 1)
you have adequate organ function, including normal kidney, liver, and bone marrow function

You likely don't qualify if…

you have received prior treatment with this specific radioactive medication (177Lu-TLX250)
you have certain cancer lesions (in the belly, bones, or lymph nodes) that do not have sufficient levels of the CAIX protein target
you are pregnant, breastfeeding, or unwilling to use effective birth control during and after the study
you have severe organ dysfunction or inadequate blood counts that have not recovered from prior treatments

What participation looks like

You will be randomly assigned to receive one of two dosing schedules of the radioactive medication through intravenous infusions. Some participants will receive 3 infusions spaced 8 weeks apart, while others will receive 6 infusions spaced 4 weeks apart. You will visit the clinic for each infusion, have regular blood tests and imaging scans to monitor how your cancer responds, and report any side effects to your care team.

AI-generated summary from trial data · Jun 24, 2026 · Not medical advice

Trial locations(5 sites)

Australia

Westmead Hospital, Sydney, New South Wales

Wollongong Hospital, Wollongong, New South Wales

Austin Health, Heidelberg, Victoria

Melbourne Theranostic Innovation Centre (MTIC), Melbourne N., Victoria

GenesisCare, Fiona Stanley Hospital (Murdoch), Murdoch, Washington