89Zr-girentuximab for PET Imaging of CAIX Positive Solid Tumors

Trial Title: 89Zr-girentuximab for PET Imaging of CAIX Positive Solid Tumors

NCT ID: NCT05563272

Condition: Cervical Cancer
Colorectal Cancer
Esophageal Cancer
Gastric Cancer
Glioblastoma Multiforme
Cholangiocarcinoma
Hepatocellular Carcinoma
Head and Neck Squamous Cell Carcinoma
Nasopharyngeal Carcinoma
Non Small Cell Lung Cancer
Small Cell Lung Cancer
Epithelial Ovarian Cancer
Pancreatic Ductal Adenocarcinoma
Soft Tissue Sarcoma

Conditions: Official terms:
Carcinoma
Lung Neoplasms
Sarcoma
Glioblastoma
Small Cell Lung Carcinoma
Nasopharyngeal Carcinoma
Cholangiocarcinoma
Squamous Cell Carcinoma of Head and Neck
Carcinoma, Ovarian Epithelial

Study type: Interventional

Study phase: Phase 2

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Diagnostic

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: 89Zr-DFO-girentuximab
Description: Single IV administration on Day 0, followed by diagnostic scan on Day 5 +/- 2 days.

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.

Criteria for eligibility:
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).

Gender: All

Minimum age: 18 Years

Maximum age: 95 Years

Healthy volunteers: No

Locations:

Facility:
Name: Biogenix Molecular, LLC

Address:
City: Miami
Zip: 33165
Country: United States

Status: Recruiting

Contact:
Last name: Jose Noel Delgado Ferreiro

Phone: 786-791-1799
Email: josenoel@biogenixmolecular.com

Facility:
Name: University Hospitals

Address:
City: Cleveland
Zip: 44106
Country: United States

Status: Recruiting

Contact:
Last name: Rahin Chowdhury
Email: Rahin.Chowdhury@UHhospitals.org

Contact backup:
Last name: Lauren Hahn
Email: Lauren.Hahn@UHhospitals.org

Facility:
Name: Austin Radiological Association (ARA)

Address:
City: Austin
Zip: 78705
Country: United States

Status: Recruiting

Contact:
Last name: Alex DiFonzo
Email: difonzoa@ausrad.com

Facility:
Name: Carilion Clinic

Address:
City: Roanoke
Zip: 24018
Country: United States

Status: Recruiting

Contact:
Last name: Maryann Hollen
Email: mhollen@carilionclinic.org

Facility:
Name: Inland Imaging

Address:
City: Spokane
Zip: 99208
Country: United States

Status: Recruiting

Contact:
Last name: Kim Wolfer
Email: kwolfer@inlandimaging.com

Start date: June 6, 2023

Completion date: December 29, 2025

Lead sponsor:
Agency: Telix Pharmaceuticals (Innovations) Pty Limited
Agency class: Industry

Source: Telix Pharmaceuticals (Innovations) Pty Limited

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05563272