Evaluation of 89Zr-TLX250 PET/CT in Chinese Patients With Indeterminate Renal Masses or Suspected… (NCT05861778) | Clinical Trial Compass
CompletedPhase 1
Evaluation of 89Zr-TLX250 PET/CT in Chinese Patients With Indeterminate Renal Masses or Suspected Recurrent Renal Clear Cell Carcinoma
China10 participantsStarted 2023-06-26
Plain-language summary
The study is designed to evaluate the safety, tolerability, radiation dosimetry and pharmacokinetics 89Zr-TLX250 (also known as 89Zr-DFO-girentuximab) Positron Emission Tomography/Computed Tomography (PET/CT) in adult Chinese patients with indeterminate renal masses or Suspected Recurrent Renal Clear Cell Carcinoma
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Voluntarily signed written informed consent
✓. Chinese male or female≥18 years old.
✓. 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
✓. 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.
✓. Expected survival ≥ 6 months.
✓. Agree to follow appropriate and highly effective contraception method for at least 35 days after the administration of 89Zr-TLX250.
Exclusion criteria
✕. Renal mass is known to be a metastasis of another primary tumor.
✕. Have other malignancies that require treatment.
✕. Planned antineoplastic therapies (for the period between IV administration of 89Zr-TLX250 and imaging).
✕. 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 \[NCICTCAE v5.0\]).
✕. Exposure to murine or chimeric antibodies within the last 5 years.
. Prior use of radionuclides with an interval of less than 10 halflives.
✕. 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.