Clinical Trial · NCT06090331

89Zr-DFO-girentuximab Expanded Access Program (EAP)

Overview

The purpose of this Expanded Access Program (EAP) is to enable the use of 89Zr-DFO-girentuximab with positron emission tomography/computed tomography (PET/CT) imaging to non-invasively detect carbonic anhydrase 9 (CAIX)-expressing clear cell renal cell carcinoma (ccRCC) in patients with renal masses as determined by conventional imaging.

Sponsor

Telix Pharmaceuticals

ClinicalTrials.gov

NCT06090331

Drug / Compound

DFO-girentuximab

Isotope(s):

Target(s):

CAIX

Ligand Class: Antibodies

Chelator: DFO

Eligibility

Inclusion

Imaging evidence of renal mass(es) obtained from conventional diagnostic imaging with CT or MRI (without and with contrast enhancement) based on national standards that is not older than 90 days on Day 0, and that was performed before any screening procedure.
1. Written and voluntarily given informed consent.
Male or female ≥ 18 years of age.
Consent to practice highly effective contraception until a minimum of 42 days after IV 89Zr-DFO-girentuximab administration.
Negative urine/serum pregnancy tests in female patients of childbearing potential.

Exclusion

Active non-renal malignancy requiring therapy during and up to EOT visit.
Planned antineoplastic therapies (for the period between IV administration of 89Zr-DFO-girentuximab and imaging).
1. Renal mass known to be a metastasis of another primary tumor.
Radiotherapy or immunotherapy within 4 weeks (28 days) prior to the planned administration of 89Zr-DFO-girentuximab or continuing adverse effects (\> grade 1 using Common Terminology Criteria for Adverse Events \[CTCAE\] version 5.0) from such therapy.
Previous administration of any radionuclide within 10 of its half-lives before Day 0.

Patient Education

Patient education not yet provided.

Publications

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