Evaluation of 89Zr-TLX250 PET/CT in Chinese Patients With Indeterminate Renal Masses or Suspected Recurrent Renal Clear Cell Carcinoma
NCT ID: NCT05861778
Last Updated: 2023-12-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
10 participants
INTERVENTIONAL
2023-06-26
2023-11-27
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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89Zr-girentuximab
A single administration of 37 MBq (+/-10%) 89Zr-girentuximab, containing a mass dose of 10 mg of girentuximab
89Zr-Girentuximab
A single administration of 37 MBq (±10%) 89Zr-TLX250, containing a mass dose of 10 mg of girentuximab, followed by whole body PET/CT scans were performed at 0.5h, 4h, 24h, 72 hours and 7±1 days post administration.
Interventions
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89Zr-Girentuximab
A single administration of 37 MBq (±10%) 89Zr-TLX250, containing a mass dose of 10 mg of girentuximab, followed by whole body PET/CT scans were performed at 0.5h, 4h, 24h, 72 hours and 7±1 days post administration.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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).
18 Years
ALL
No
Sponsors
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Grand Pharmaceutical (China) Co., Ltd.
OTHER
Telix Pharmaceuticals (Innovations) Pty Limited
INDUSTRY
Responsible Party
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Principal Investigators
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Zhi Yang
Role: PRINCIPAL_INVESTIGATOR
Peking University Cancer Hospital & Institute
Locations
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Peking University Cancer Hospital & Institute
Beijing, , China
Countries
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Other Identifiers
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TLX250CDx-CP-001
Identifier Type: -
Identifier Source: org_study_id