89Zr-girentuximab for PET Imaging of CAIX Positive Solid Tumors (NCT05563272) | Clinical Trial Compass
TerminatedPhase 2
89Zr-girentuximab for PET Imaging of CAIX Positive Solid Tumors
Stopped: Indication scouting for TLX250-CDx will continue in theranostic studies, with a therapeutic component in the study design.
United States11 participantsStarted 2023-06-06
Plain-language summary
A prospective, open-label, phase 2 study to explore CAIX expression through 89Zirconium-labelled girentuximab deferoxamine (89Zr-girentuximab) PET/CT imaging in patients with solid tumors.
Who can participate
Age range18 Years – 95 Years
SexALL
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Inclusion criteria
✓. Written and voluntarily given Informed Consent.
✓. Male or female ≥18 years of age at time of consent.
✓. Have the capacity to understand the study and be willing and able to comply with all protocol requirements.
✓. Participants must have proven tumors of the following types, but not limited to:
✓. Have at least one non-central nervous system (CNS), measurable target lesion as defined per RECIST 1.1 and documented by SOC conventional imaging, performed within 60 days (+14 days) prior to Day 0 (excepting participants with GBM or hemangioblastoma, given that all lesions may be in the CNS, such lesions assessed by RANO);
✓. Have agreed not to receive another investigational product while participating in the present study, defined as signing the informed consent form (ICF), until completion of the last study visit;
✓. Have negative serum pregnancy tests if a female of childbearing potential at screening and have a confirmatory negative urine pregnancy test result within 24 hours prior to receiving investigational product. Female participants of non-child- bearing potential must provide evidence by fulfilling one of the following criteria at screening:
✓. Have consented to practice highly effective method of contraception until a minimum of 42 days after 89Zr-girentuximab administration
Exclusion criteria
✕. Have been administered any radionuclide within 10 half-lives (of the radionuclide) prior to the intended administration of 89Zr-girentuximab (i.e., within 10 half-lives of Day 0);
What they're measuring
1
Qualitative assessment of 89Zr-girentuximab uptake within individual tumor deposits
Timeframe: Single diagnostic administration, followed by a diagnostic scan on Day 5 ± 2 days. This assessment will be conducted throughout the patient dosing and imaging period, an average of 18 months
2
Quantitative assessment of 89Zr-girentuximab uptake within individual tumor deposits
Timeframe: Single diagnostic administration, followed by a diagnostic scan on Day 5 ± 2 days. This assessment will be conducted throughout the patient dosing and imaging period, an average of 18 months
✕. Have been exposed to any CAIX targeting compound (diagnostic/therapeutic) in the prior 3 months;
✕. Have any 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 participant, as judged by the Investigator;
✕. Have any clinically significant abnormalities detected during screening laboratory tests or physical exam that, in the opinion of the Investigator, would adversely affect the participant's ability to participate in the study;
✕. Have a mental impairment that may compromise the ability to give Informed Consent and comply with the requirements of the study;
✕. Have been exposed to any antineoplastic treatment from Day 0 (89Zr-girentuximab dosing) to completion of 89Zr-girentuximab PET/CT imaging (Day 5 ± 2 days);
✕. Be a female who is pregnant or breastfeeding;
✕. Have a known allergy, hypersensitivity, or intolerance to girentuximab, desferrioxamine (DFO), or any of the components of the investigational agent;