Using 89Zr-girentuximab for PET imaging of certain solid tumors
Study of 89Zr-girentuximab for PET Imaging of Solid Tumors Likely to Express High Levels of CAIX
This study is testing a special imaging tool to see if it can help spot a protein linked to certain solid tumors in patients with cancers like cervical, colorectal, and gastric.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 95 Years |
| Sex | All |
| Sponsor | Telix Pharmaceuticals (Innovations) Pty Limited Industry-sponsored |
| Drugs / interventions | girentuximab |
| Locations | 5 sites (Miami, Florida and 4 other locations) |
| Trial ID | NCT05563272 on ClinicalTrials.gov |
What this trial studies
This phase 2 interventional study aims to evaluate the expression of carbonic anhydrase IX (CAIX) in patients with various solid tumors using 89Zr-girentuximab PET/CT imaging. Participants will receive an injection of 89Zr-DFO-girentuximab, which is a radiolabeled antibody designed to target CAIX, a protein often overexpressed in certain cancers. The study will include patients with confirmed diagnoses of cervical, colorectal, esophageal, gastric, glioblastoma, and other solid tumors, allowing for the assessment of CAIX expression in these malignancies. The results may help in better understanding tumor biology and improving imaging techniques for cancer detection.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with histologically confirmed solid tumors such as cervical, colorectal, esophageal, gastric, or glioblastoma multiforme.
Not a fit: Patients with non-solid tumors or those who do not express CAIX may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the accuracy of PET imaging for detecting CAIX-positive tumors, leading to better treatment planning and outcomes for patients.
How similar studies have performed: Other studies using targeted imaging agents for cancer detection have shown promise, suggesting that this approach may yield beneficial results.
Eligibility criteria
Show full inclusion / exclusion criteria
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 histologically or cytologically proven solid tumors of the following types, but not limited to: * cervical cancer * colorectal cancer * esophageal cancer (esophageal SCC and esophageal/esophagogastric junction adenocarcinoma) * gastric cancer (gastric adenocarcinoma) * glioblastoma multiforme * head and neck cancer (head and neck SCC and nasopharyngeal carcinoma) * liver cancer (cholangiocarcinoma and hepatocellular carcinoma) * lung cancer (non-small cell and small cell) * ovarian cancer (epithelial ovarian carcinoma) * pancreatic cancer (pancreatic ductal adenocarcinoma) * soft tissue sarcoma * At least one non-CNS, measurable target lesion as per RECIST 1.1 documented at conventional imaging, performed within 30 days prior to Day 0. * Participant agrees not to participate in another interventional study while participating in the present study, defined as signing the informed consent form (ICF) until completion of the last study visit. * Negative serum pregnancy tests in female patients of childbearing potential at screening and confirmation of negative pregnancy test result from urine within24 hours prior to receiving investigational product. Female patients of non-child-bearing potential must provide evidence by fulfilling one of the following criteria at screening: * Post-menopausal defined as aged more than 50 years and amenorrheic for at least 12 months following cessation of all exogenous hormonal treatments. * Women under 50 years old would be consider postmenopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatments and with luteinizing hormone (LH) and follicle-stimulating hormone (FSH) levels in the post-menopausal range for the institution. * Documentation of irreversible surgical sterilization by hysterectomy, bilateral oophorectomy, or bilateral salpingectomy but not tubal ligation * For all participants, consent to practice double-barrier contraception until a minimum of 42 days after 89Zr-girentuximab administration. Exclusion Criteria: * Exposure to murine or chimeric antibodies within the last 5 years. * Previous administration of any radionuclide within 10 half-lives (of the radionuclide) prior to the intended administration of 89Zr-girentuximab(i.e., within 10 half-lives of Day0). * Exposure to any CAIX targeting compound (diagnostic/therapeutic) in the last 3 months * 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 subject, as judged by the Investigator. * Any clinically significant abnormalities detected during screening laboratory tests or physical exam that in the opinion of the Investigator would adversely affect the participants ability to participate in the study. Principal Investigator to assess patient suitability for inclusion based on pathology and tumor type. * Mental impairment that may compromise the ability to give Informed Consent and comply with the requirements of the study. * Exposure to any antineoplastic treatment within 14 days from the date of planned administration of 89Zr-girentuximab(i.e. within 14 days of Day 0). * Women who are pregnant or breastfeeding. * Known allergy, hypersensitivity, or intolerance to girentuximab, DFO (desferrioxamine),or any of the components of the investigationalagent.10.Renal insufficiency with glomerular filtration rate (GFR) ≤ 45 millilitres/min/1.73m2 * Vulnerable patients (e.g. being in detention).
Where this trial is running
Miami, Florida and 4 other locations
- Biogenix Molecular, LLC — Miami, Florida, United States (Recruiting)
- University Hospitals — Cleveland, Ohio, United States (Recruiting)
- Austin Radiological Association (ARA) — Austin, Texas, United States (Recruiting)
- Carilion Clinic — Roanoke, Virginia, United States (Recruiting)
- Inland Imaging — Spokane, Washington, United States (Recruiting)
Study contacts
- Study coordinator: Kavita Vadali
- Email: global-clinicaltrials@telixpharma.com
- Phone: +61 3 9093 3808
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.