Phase 1 Kidney Cancer Trial, Recruiting NCT05868174 Sponsor: Telix Pharmaceuticals (Innovations) Pty Limited Condition: Kidney Cancer
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Phase 1 Kidney Cancer Trial, Recruiting

NCT05868174
Recruiting Phase 1 🇦🇺 Australian site

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People who have an advanced or spreading solid tumour that has grown or worsened despite standard treatments, and whose tumour cannot be surgically removed, or who are not suitable for or have chosen not to have standard treatments.
  • People who have at least one tumour that can be measured on a CT or MRI scan, and whose tumour shows uptake of a special imaging agent called 89Zr-TLX250 (meaning the tumour has a protein on it called CAIX).
  • People whose tumours show CAIX activity across at least 75% of the total tumour volume, based on how strongly the imaging agent is taken up compared to the liver.
  • People who are in generally good physical condition and able to carry out normal daily activities with little or no limitation (rated 0 or 1 on a standard medical scale called ECOG).
  • People whose heart, liver, kidneys, and other organs are functioning adequately at the time of screening.
  • People who have a life expectancy of at least 6 months.

Who may not be able to join:

  • People who have previously received a treatment called 177Lu-TLX250, any other radioligand therapy, or any treatment that targets the CAIX protein.
  • People who have a known allergy or sensitivity to the study drugs or similar substances, including the imaging agent or any ingredients in the study medications.
  • People who have received a radioactive (radionuclide) treatment recently — specifically within 10 half-lives of that substance before signing the consent form (confirm with trial site for exact timing).
  • People who have had chemotherapy, significant radiation therapy, biological cancer treatment, or another experimental treatment within 28 days before the first planned dose of study treatment.
  • People who have had more than 2 previous rounds of chemotherapy, or who experienced severe drops in certain blood cell counts (white blood cells or platelets) during their most recent chemotherapy.
  • People who cannot stop taking certain medications or herbal supplements that strongly affect how the body processes some drugs (specifically those that strongly inhibit or stimulate enzymes called CYP3A4/5, CYP2C9, and CYP2C19), or who are taking certain other medications that interact with these enzymes.
  • People who cannot stop taking stomach acid-reducing medications called H2-blockers or proton-pump inhibitors (PPIs) at least 5 days before starting the study treatment. Note: calcium carbonate does not need to be stopped.
  • People who are taking blood thinners or anti-clotting medications at treatment doses, including low-molecular weight heparin or platelet-thinning drugs.
  • People who have 5 or more bone tumours, or large tumours (bigger than 3 cm) in the pelvis or thigh bone area, or tumours in the spine affecting more than 3 vertebrae.
  • People who have another serious medical condition that, in the treating doctor's opinion, would make participation unsafe or difficult.
  • People who have an active, uncontrolled infection or another serious illness that, in the treating doctor's opinion, would put them at too much risk or affect their ability to take part.
  • People who need to continue receiving other cancer treatments at the same time as the study medications (supportive care is allowed).

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 28 July 2026
Phase 1: approximately ~10% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Australian sites

Macquarie University, North Ryde, New South Wales
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Ashford (Icon) Cancer Centre, Adelaide,
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Princess Alexandra Hospital, Brisbane,
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Austin Health, Melbourne,
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GenesisCare Murdoch, Perth,
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Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 1
Sponsor
Telix Pharmaceuticals (Innovations) Pty Limited
Registry
ClinicalTrials.gov
Start date
23 May 2023
Est. completion
1 December 2024

Where this trial is recruiting

🇦🇺 Australia

5 site(s) in Australia. Confirm current status and contact details directly with the trial site.

Primary endpoints

Safety parameter Dose Limited Toxicity (DLT); Safety parameter Laboratory Examinations; Safety parameter Vital signs; Safety parameter ECG; Safety parameter Adverse Events and Treatment-Related Adverse Events; Disease impact causing changes in Eastern Cooperative Oncology Group (ECOG) Performance scale.

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov