Actively Recruiting

Phase 3
Age: 18Years +
All Genders
ID07197580

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

Led by Telix Pharmaceuticals (Innovations) Pty Limited · Updated on 2026-04-01

40

Participants Needed

5

Research Sites

78 weeks

Total Duration

On this page

Sponsors

T

Telix Pharmaceuticals (Innovations) Pty Limited

Lead Sponsor

M

Medpace, Inc.

Collaborating Sponsor

AI-Summary

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 investigator's 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 therapy's impact and tolerability over time.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Be aged 18 years or older.
  • Provide written informed consent before any study procedures.
  • Have relapsed, recurrent, locally advanced, or metastatic clear cell renal cell carcinoma confirmed by biopsy.
  • Have received 2 to 3 prior systemic therapies including PD-1/PD-L1 inhibitors and VEGF/VEGFR-targeting agents.
  • Show disease progression or intolerance to the most recent therapy.
  • Have at least one measurable lesion according to RECIST 1.1 criteria.
  • Be CAIX-positive based on PET scan criteria.
  • Have an ECOG Performance Status of 0 or 1.
  • Have recovered from side effects of prior therapies except controlled Grade 2 neurotoxicity.
  • Have adequate bone marrow, liver, and kidney function as defined by specific lab values.
  • Women of childbearing potential must have a negative pregnancy test.
Not Eligible

You will not qualify if you...

  • Have metastatic lesions with CAIX tumor-to-liver ratio less than 1.
  • Received prior 177Lu-TLX250 or other CAIX-targeting therapies.
  • Known allergy to study drug components or related substances.
  • Received granulocyte colony stimulating factor or erythropoietin within 4 weeks before screening.
  • Recent radionuclide, anticancer therapy, or radiotherapy within defined timeframes before study drug.
  • Known untreated or unstable brain metastases.
  • Major surgery or trauma within 3 weeks before treatment.
  • Pregnant or breastfeeding, or planning pregnancy during and after the study.
  • Active, uncontrolled infections or severe concurrent diseases.
  • History of other malignancies with limited exceptions.
  • Serious non-healing wounds or fractures.
  • Unable to remain still for imaging scans.
  • Unresolved significant toxic effects from prior therapies except specified exceptions.
  • Inflammatory bowel disease.
  • Life expectancy less than 3 months.
  • Bleeding or thrombotic disorders or recent significant bleeding events.
  • Serious illnesses affecting heart, lungs, nervous system, kidneys, liver, or blood that may affect study participation or safety.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Approximately 4 months

Participants receive 3 infusions of 1887 MBq 177Lu-TLX250 at 8-week intervals or 6 infusions of 1258 MBq 177Lu-TLX250 at 4-week intervals as part of the radioligand therapy.

3 to 6 infusion visits depending on dosing regimen

Follow-up

Duration - Up to 2 years

Participants are monitored for safety, efficacy, and health outcomes after completion of treatment.

Regular visits for assessments through study completion

Trial Site Locations

Total: 5 locations

1

Westmead Hospital

Sydney, New South Wales, Australia, 2145

Not Yet Recruiting

2

Wollongong Hospital

Wollongong, New South Wales, Australia, 2500

Not Yet Recruiting

3

Austin Health

Heidelberg, Victoria, Australia, 3084

Not Yet Recruiting

4

Melbourne Theranostic Innovation Centre (MTIC)

Melbourne N., Victoria, Australia, 3051

Not Yet Recruiting

5

GenesisCare, Fiona Stanley Hospital (Murdoch)

Murdoch, Washington, Australia, 6150

Actively Recruiting

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Research Team

P

Prson Gautam, PhD

L

Lily Nahidi, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

Phase 2 Study of Lutetium 177-Labeled Anti-Carbonic Anhydrase IX Monoclonal Antibody Girentuximab in Patients with Advanced Renal Cell Carcinoma.

Constantijn H J Muselaers, Marye J Boers-Sonderen, Tim J van Oostenbrugge...

https://pubmed.ncbi.nlm.nih.gov/26706103

Phase 1 radioimmunotherapy study with lutetium 177-labeled anti-carbonic anhydrase IX monoclonal antibody girentuximab in patients with advanced renal cell carcinoma.

Alexander B Stillebroer, Otto C Boerman, Ingrid M E Desar...

https://pubmed.ncbi.nlm.nih.gov/22980441