Phase 3 Kidney Cancer Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People who are 18 years of age or older
• People who have signed and dated a written consent form before any study-related procedures begin
• People who have kidney cancer (renal cell carcinoma, or RCC) that has come back, spread to nearby areas, or spread to other parts of the body, and whose diagnosis has been confirmed through a tissue or cell sample showing a "clear cell" type, with or without certain aggressive features (called sarcomatoid features)
• People who have already received at least 2 but no more than 3 previous treatment courses for advanced or spreading kidney cancer, including at least one immune checkpoint therapy (a PD-1 or PD-L1 inhibitor, given at least twice) and at least one treatment targeting blood vessel growth (a VEGF/VEGFR-targeting drug), given either separately or together
• People whose cancer has continued to grow or spread during or after their most recent treatment, or who could not tolerate their most recent treatment
• People who have at least one area of cancer that can be measured on a scan, following standard measurement guidelines (RECIST v1.1); areas that were previously treated with radiation may count if growth has been shown there
• People whose cancer tests positive for a protein called CAIX on a special PET scan using a study imaging agent (89Zr-TLX250), meaning at least one tumour area shows a specific level of CAIX activity compared to the liver (confirm with trial site for exact scan details)
• People who are generally well enough to carry out light activity or desk work — rated 0 or 1 on a standard health and activity scale used in cancer trials (ECOG Performance Status)
• People who have recovered from side effects of previous treatments, or whose side effects have returned to their pre-treatment levels (some ongoing but controlled side effects, such as an underactive thyroid or high blood pressure, are permitted; some mild nerve-related side effects may also be permitted)
• People whose blood, liver, and kidney function meet the following minimum levels as shown by recent blood tests:
  • White blood cell count of at least 3,000 per microlitre
  • Neutrophil count (a type of white blood cell) of at least 1,500 per microlitre, without having received a white blood cell-boosting injection in the 4 weeks before the first study treatment dose
  • Platelet count of at least 100,000 per microlitre, without having received a platelet transfusion in the 4 weeks before the first study treatment dose
  • Haemoglobin (red blood cell measure) of at least 9 g/dL, without having received a red blood cell transfusion in the 2 weeks before the first study treatment dose
  • Liver enzyme levels (ALT and AST) within acceptable ranges (up to 2.5 times normal, or up to 5 times normal if the cancer has spread to the liver)
  • Total bilirubin (a liver marker) at or below 1.5 times the normal upper limit (up to 3 times normal is allowed for people with a known condition called Gilbert's Syndrome)
  • Kidney filtration rate of at least 40 mL/min, measured by a standard formula or a 24-hour urine collection
• Women who could potentially become pregnant must have a negative blood pregnancy test at the screening stage

Who may not be able to join:

• People who have certain types of cancer deposits (in organs, bone, or lymph nodes of a certain size) that do not show sufficient CAIX activity on the special PET scan (confirm with trial site for exact technical thresholds)
• People who have previously received the study treatment (177Lu-TLX250), any other radioligand therapy, or any treatment that targets the CAIX protein
• People who have a known allergy or sensitivity to ingredients similar to those in the study drugs, including the antibody girentuximab, certain chemical linkers (DFO or DOTA), the metals zirconium or lutetium, or any contrast agents used in scans
• People who have received a white blood cell-boosting injection (G-CSF) or a red blood cell-stimulating drug (erythropoietin) within 4 weeks before the screening blood tests
• People who have recently received certain other treatments, including:
  • Any radioactive substance within 10 half-lives of that substance before the first imaging scan in the study (confirm with trial site for timing details)
  • Any systemic (whole-body) cancer treatment within 2 weeks before the first study treatment dose
  • Radiotherapy (radiation treatment) within 2 weeks before the first study treatment dose, unless fully recovered and no longer needing steroids
  • Short-course palliative radiation (for symptom relief, not to the brain) within 1 week of the first study treatment dose
• People who have cancer that has spread to the brain, unless it has been treated and remained stable for at least 4 weeks before the first study treatment dose, confirmed by a brain scan at screening
• People who have had major surgery (such as abdominal, heart, or chest surgery) or a significant injury within 3 weeks before the first study treatment dose
• People who are pregnant, planning to become pregnant, or planning to breastfeed during the study and for specified periods after the last dose of either study drug (at least 42 days after the last imaging dose or 6 months after the last treatment dose, whichever comes last; breastfeeding must be avoided for 28 days after the last imaging dose or 75 days after the last treatment dose)
• People who have an active, uncontrolled infection requiring treatment, or another serious illness that the study doctor believes would put them at undue risk or affect study results
• People who have another active cancer with a life expectancy of 2 years or less, or that requires ongoing cancer treatment that could interfere with study results (note: certain low-risk skin cancers, early-stage cancers confined to one area, or an incidental finding of prostate cancer may still be eligible — confirm with trial site)
• People who have a wound, ulcer, or bone fracture that is not healing
• People who are unable to lie still in a scanner with their arms in the required position for the full duration of the scan
• People who still have significant side effects (above a mild level) from previous cancer treatment, surgery, or radiotherapy that have not resolved, with some exceptions such as mild hair loss or stable mild nerve symptoms (confirm with trial site for exact grading details)
• People who have inflammatory bowel disease, such as Crohn's disease or ulcerative colitis
• People whose life expectancy is shorter than 3 months
• People who have bleeding or clotting disorders, or who are at high risk of serious bleeding
• People who have had a significant bleeding episode (including coughing up blood or bleeding from a tumour) within 2 weeks before the first study treatment dose
• People who have serious heart conditions (such as severe heart failure classified as NYHA Class III or IV), a significantly abnormal heart rhythm reading (prolonged QT interval), active or hidden serious infections, or other serious conditions affecting the heart, lungs, brain, kidneys, liver, or blood system that could interfere with the study or the ability to assess side effects
• People who have any other medical or personal circumstance that the study doctor believes would make participation in the trial unsuitable

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