Evaluation of 89Zr-TLX250 PET/CT in Chinese Patients With Indeterminate Renal Masses or Suspected Recurrent Renal Clear Cell Carcinoma

Launched by TELIX PHARMACEUTICALS (INNOVATIONS) PTY LIMITED · May 14, 2023

Keywords

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Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Voluntarily signed written informed consent
• • 2. Chinese male or female≥18 years old.
• • 3. Have an indeterminate renal mass, suspected renal cell carcinoma, or previously diagnosed ccRCC, suspected recurrence on the pre-screening imaging from Day -90 to Day -1
• • 4. Negative serum pregnancy test for female subjects of childbearing potential at screening. Confirmed negative urine pregnancy test within 24 hours prior to administration of investigational product.
• • 5. Expected survival ≥ 6 months.
• • 6. Agree to follow appropriate and highly effective contraception method for at least 35 days after the administration of 89Zr-TLX250.
• Exclusion Criteria:
• • 1. Renal mass is known to be a metastasis of another primary tumor.
• • 2. Have other malignancies that require treatment.
• • 3. Planned antineoplastic therapies (for the period between IV administration of 89Zr-TLX250 and imaging).
• • 4. Have received chemotherapy, radiotherapy, or immunotherapy within 4 weeks prior to the planned administration of 89Zr-TLX250 or such therapy resulted in a persistent adverse event (\> Grade 1) (per National Cancer Institute-Common Toxicity Criteria version 5.0 \[NCICTCAE v5.0\]).
• • 5. Exposure to murine or chimeric antibodies within the last 5 years.
• • 6. Prior use of radionuclides with an interval of less than 10 halflives.
• • 7. Exposure to any investigational diagnostic or therapeutic agent within the first 4 weeks or 5 half-lives (whichever is longer) of the planned administration of 89Zr-TLX250.
• • 8. Renal insufficiency with glomerular filtration rate (GFR) ≤ 60 mL/min/1.73 m².
• • 9. Uncontrolled psychiatric disorders.
• • 10. Women who are pregnant or breastfeeding.
• • 11. Known hypersensitivity to girentuximab or DFO (deferoxamine).
• • 12. Have a serious non-malignant disease (e.g., infectious disease, autoimmune disease, or metabolic disease) that, in the opinion of the investigator, may interfere with the purpose of the study or subject safety or compliance.
• • 13. Vulnerable population (e.g., being in detention).