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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 95 Years
Gender All
More 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).

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05563272
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Telix Pharmaceuticals (Innovations) Pty Limited
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Biogenix Molecular, LLC, Miami, Florida

Status

Recruiting

Address

Biogenix Molecular, LLC

Miami, Florida, 33165

Site Contact

Jose Noel Delgado Ferreiro

josenoel@biogenixmolecular.com

786-791-1799

University Hospitals, Cleveland, Ohio

Status

Recruiting

Address

University Hospitals

Cleveland, Ohio, 44106

Site Contact

Rahin Chowdhury

Rahin.Chowdhury@UHhospitals.org

+61 3 9093 3808

Austin Radiological Association (ARA), Austin, Texas

Status

Recruiting

Address

Austin Radiological Association (ARA)

Austin, Texas, 78705

Site Contact

Alex DiFonzo

difonzoa@ausrad.com

+61 3 9093 3808

Carilion Clinic, Roanoke, Virginia

Status

Recruiting

Address

Carilion Clinic

Roanoke, Virginia, 24018

Site Contact

Maryann Hollen

mhollen@carilionclinic.org

+61 3 9093 3808

Inland Imaging, Spokane, Washington

Status

Recruiting

Address

Inland Imaging

Spokane, Washington, 99208

Site Contact

Kim Wolfer

kwolfer@inlandimaging.com

+61 3 9093 3808