89Zr-TLX250 for PET/CT Imaging of ccRCC - ZIRCON-CP Study
A Confirmatory, Open-label, Single-arm, Multi-centre Study to Evaluate Safety, Tolerability and Diagnostic Performance of 89Zirconium-labelled Girentuximab (89Zr-TLX250) to Non-invasively Detect Clear Cell Renal Cell Carcinoma (ccRCC) by Positron Emission Tomography/Computed Tomography (PET/CT) Imaging in Chinese Patients With Indeterminate Renal Masses (ZIRCON-CP Study)
Telix Pharmaceuticals (Innovations) Pty Limited
82 participants
Nov 6, 2024
INTERVENTIONAL
Conditions
Summary
89Zr-TLX250 is under clinical development as a diagnostic agent targeting clear cell renal cell carcinoma, and this Phase 3 bridging study in mainland Chinese patients is intended to support the successful ZIRCON data (ZIRCON Clinicaltrial.gov ID: NCT03849118)
Eligibility
Inclusion Criteria7
- Written and voluntarily given informed consent.
- Mainland Chinese male or female, aged ≥ 18 years.
- Imaging evidence of a single IRM of ≤ 7 cm in largest diameter (tumour stage cT1), on SoC imaging based on national standards, not older than 90 days on Day 0, but performed before any screening procedure.
- Scheduled for lesion resection as part of regular diagnostic work-up within 90 days from planned IV 89Zr-TLX250 administration.
- Negative serum pregnancy tests in female patients of childbearing potential at screening. Confirmation of negative pregnancy test result from urine within 24 hours prior to receiving investigational product.
- Sufficient life expectancy to justify nephrectomy.
- Consent to practise highly effective contraception until a minimum of 42 days after IV 89Zr-TLX250 administration.
Exclusion Criteria15
- A biopsy procedure only (rather than partial or total nephrectomy) is planned for histological species delineation of IRM.
- Renal mass known to be a metastasis of another primary tumour.
- Active non-renal malignancy requiring therapy during the time frame of the study participation.
- Multiple unilateral or bilateral IRM.
- Chemotherapy, radiotherapy, targeted therapy or immunotherapy within 4 weeks prior to the planned administration of 89Zr -TLX250 or continuing adverse effects (\> grade 1) from such therapy (Common Terminology Criteria for Adverse Events \[CTCAE\] version 5.0).
- Planned antineoplastic therapies (for the period between IV administration of 89Zr-TLX250 and imaging).
- Exposure to murine or chimeric antibodies within the last 5 years.
- Previous administration of any radionuclide within 10 half-lives of the same.
- Serious non-malignant disease (e.g. psychiatric, infectious, autoimmune or metabolic), that may interfere with the objectives of the study or with the safety or compliance of the study subject, as judged by the investigator.
- Mental impairment that may compromise the ability to give informed consent and comply with the requirements of the study.
- Exposure to any experimental diagnostic or therapeutic drug within 4 weeks or 5 half-lives (whichever is longer) from the date of planned administration of 89Zr-TLX250.
- Women who are pregnant or breastfeeding.
- Known hypersensitivity to girentuximab or desferoxamine (DFO).
- Renal insufficiency with glomerular filtration rate (GFR) ≤ 45 mL/min/1.73 m².
- Vulnerable patients (e.g., being in detention).
Interventions
89Zr-TLX250, is a chimeric monoclonal antibody (INN name: girentuximab) with specificity for the CAIX (carbonic anhydrase 9) antigen, radiolabelled with the positron emitting radiometal zirconium- 89. Girentuximab has a CAS number of 916138-87-9. The chemical formula, without the 89Zr and the desferrioxamine, is C6460H1006N1718O2018S48 with a molecular mass of 146.5 kg/mol. 89Zr-TLX250 is formulated as a solution for IV administration in glass vials at the nominal dosage strength of 37 MBq (±10%) for single IV use. The mass dose of 89Zr-TLX250 to be used in this Phase 3 study will be 10 mg, labelled with 37 MBq (±10%) 89Zr per dose.
Locations(8)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06750419