Clinical Trial · NCT03849118

89Zr-TLX250 for PET/CT Imaging of ccRCC- ZIRCON Study

Overview

89Zr-TLX250 is under clinical development as a diagnostic agent targeting clear cell renal cell carcinoma.

Sponsor

Phase

Phase 3

Contacts

Howard Gurney, MD (PRINCIPAL_INVESTIGATOR)

Carlos Artigas Guix, MD (PRINCIPAL_INVESTIGATOR)

Andrew Scott, MD (PRINCIPAL_INVESTIGATOR)

Simon Wood, MD (PRINCIPAL_INVESTIGATOR)

Francoise Brodere, MD (PRINCIPAL_INVESTIGATOR)

Martin Geert Steffens, MD (PRINCIPAL_INVESTIGATOR)

Mark Frydenberg, MD (PRINCIPAL_INVESTIGATOR)

Nicolas Lumen, MD (PRINCIPAL_INVESTIGATOR)

Sumer Baltaci, MD (PRINCIPAL_INVESTIGATOR)

Declan Murphy, MD (PRINCIPAL_INVESTIGATOR)

Jean-Christophe Bernhard, MD (PRINCIPAL_INVESTIGATOR)

Bulent Akdogan, MD (PRINCIPAL_INVESTIGATOR)

Marcel Stokkel, MD (PRINCIPAL_INVESTIGATOR)

Tamer Aksoy, MD (PRINCIPAL_INVESTIGATOR)

Bulent Onal, MD (PRINCIPAL_INVESTIGATOR)

Peter Mulders, MD (PRINCIPAL_INVESTIGATOR)

Karolien Goffin, MD (PRINCIPAL_INVESTIGATOR)

David Chan (PRINCIPAL_INVESTIGATOR)

Pierre Olivier, MD (PRINCIPAL_INVESTIGATOR)

Linda Heijmen, MD (PRINCIPAL_INVESTIGATOR)

ClinicalTrials.gov

Eligibility

Negative serum pregnancy tests in female patients of childbearing potential (at Screening and within 24 hours prior to receiving investigational product)
for patients included in France only, verification and confirmation of their affiliation with a social security
Consent to practice double-barrier contraception until a minimum of 42 days after 89Zr-TLX250 administration
Imaging evidence of a single indeterminate renal mass of ≤7cm in largest diameter (tumour stage cT1) , on CT or MRI with and without contrast agent, suspicious for ccRCC
Scheduled for lesion resection as part of regular diagnostic work-up within 90 days from planned 89Zr-TLX250 administration
Sufficient life expectancy to justify nephrectomy

Exposure to murine or chimeric antibodies within the last 5 years
Chemotherapy, radiotherapy 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)
Renal mass known to be a metastasis of another primary tumour
Known hypersensitivity to Girentuximab or DFO (Desferrioxamine)
Serious non-malignant disease (e.g. psychiatric, infectious, autoimmune or metabolic) that may interfere with the objectives of the study or within the safety of compliance of the subjects as judged by the Investigator
Previous administration of any radionuclide within 10 half-lives of the same
Bioptic procedure (rather than a partial or total nephrectomy) planned for histological species delineation of IRM
Vulnerable patients (e.g being in detention)
Women who are pregnant or breastfeeding
Planned antineoplastic therapies (for the period between administration of 89 Zr-TLX250 and imaging)
Exposure to any experimental diagnostic or therapeutic drug within 30 days from the date of planned administration of 89Zr-TLX250
Active non-renal malignancy requiring therapy during the time frame of the study participation
Renal insufficiency with glomerular filtration rate (GFR) ≤ 60 millilitres/min/1.73m2

Patient Education

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