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New treatment option for Clear Cell Renal Cell Carcinoma
Official title 89Zr-TLX250 for PET/CT Imaging of ccRCC - ZIRCON-CP Study
ClinicalTrials.gov ID: NCT06750419
What this study is testing
What is 89Zr-TLX250 PET/CT?
89Zr-TLX250 PET/CT is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for clear cell renal cell carcinoma.
Also referred to as 89Zr-DFO-girentuximab, 89Zr-girentuximab.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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)
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- 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...
You likely can't join if
- 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...
- Planned antineoplastic therapies (for the period between IV administration of 89Zr-TLX250 and imaging).
See the full eligibility criteria
- 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.
- 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...
- 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...
- 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).
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, China
- Hangzhou, China
- Hubei, China
- Shanghai, China
- Suzhou, China
- Tianjin, China
- Wuxi, China
- Zhejiang, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, China; Hangzhou, China; Hubei, China; Shanghai, China; Suzhou, China; Tianjin, China and 2 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.