The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT05563272
Recruitment Status : **RECRUITING NOW**
First Posted : October 3, 2022
Last Update Posted : June 13, 2023
Sponsor:
Information provided by (Responsible Party):
Telix International Pty Ltd
Go toÂ
Brief 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.
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
Drug: 89Zr-DFO-girentuximab
Phase 2
Go toÂ
Layout table for study information
Study Type :
Interventional  (Clinical Trial)
Estimated Enrollment :
100 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Study of 89Zr-girentuximab for PET Imaging of Solid Tumors Likely to Express High Levels of CAIX
Estimated Study Start Date :
June 6, 2023
Estimated Primary Completion Date :
December 8, 2025
Estimated Study Completion Date :
December 29, 2025
Resource links provided by the National Library of Medicine
Go toÂ
Intervention Details:
Go toÂ
Primary Outcome Measures :
Qualitative assessment of 89Zr-girentuximab uptake within individual tumor deposits [ Time Frame: 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 ]
This outcome will be evaluated on all patients by using a PET/CT machine to qualitatively assess (yes / no) the uptake of the 89Zr-girentuximab uptake within individual tumor deposits.
Quantitative assessment of 89Zr-girentuximab uptake within individual tumor deposits [ Time Frame: 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 ]
This outcome will be evaluated on all patients by using a PET/CT machine to quantitatively assess the uptake of the 89Zr-girentuximab uptake within individual tumor deposits.
Secondary Outcome Measures :
To evaluate safety parameter of Heart rate in patients administered with 89Zr-girentuximab [ Time Frame: Patients will be evaluated for the period up to imaging following administration of 89Zr-girentuximab, at most 7 days. ]
This outcome will be measured as beats per minute on all patients with treatment-related adverse events based on criteria as determined by the NCI CTCAE v 5.0 criteria
To evaluate safety parameter of blood pressure in patients administered with 89Zr-girentuximab. [ Time Frame: Patients will be evaluated for the period up to imaging following administration of 89Zr-girentuximab, up to 7 days. ]
This outcome will be measured as mmHg on all patients with treatment-related adverse events based on criteria as determined by the NCI CTCAE v 5.0 criteria
To evaluate safety parameter related to Liver function in patients administered 89Zr-girentuximab [ Time Frame: Patients will be evaluated for the period up to imaging following administration of 89Zr-girentuximab, up to 7 days. ]
This outcome will be measured on all patients with treatment-related adverse events based on criteria as determined by the NCI CTCAE v 5.0 criteria. Results will be assessed by number of participants with abnormal laboratory values.
To evaluate safety parameter related to Renal function in patients administered 89Zr-girentuximab [ Time Frame: Patients will be evaluated for the period up to imaging following administration of 89Zr-girentuximab, up to 7 days. ]
This outcome will be measured on all patients with treatment-related adverse events based on criteria as determined by the NCI CTCAE v 5.0 criteria. Results will be assessed by number of participants with abnormal laboratory values.
To evaluate safety parameter related to Full Blood Count in patients administered 89Zr-girentuximab [ Time Frame: Patients will be evaluated for the period up to imaging following administration of 89Zr-girentuximab, up to 7 days. ]
This outcome will be measured on all patients with treatment-related adverse events based on criteria as determined by the NCI CTCAE v 5.0 criteria. Results will be assessed by number of participants with abnormal laboratory values.
Go toÂ
Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Layout table for eligibility information
Ages Eligible for Study: Â
18 Years to 95 Years  (Adult, Older Adult)
Sexes Eligible for Study: Â
All
Accepts Healthy Volunteers: Â
No
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-smallcell 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 luteinizinghormone (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).
Go toÂ
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05563272
Layout table for location information
Carilion Clinic
Roanoke, Virginia, United States, 24018
Contact: Maryann Hollen      Â
Inland Imaging
Spokane, Washington, United States, 99208
Contact: Kim Wolfer      Â
Telix International Pty Ltd
Go toÂ
Layout table for additonal information
Responsible Party:
Telix International Pty Ltd
ClinicalTrials.gov Identifier:
NCT05563272 Â Â
Other Study ID Numbers:
89Zr-TLX250-005
First Posted:
October 3, 2022 Â Â Key Record Dates
Last Update Posted:
June 13, 2023
Last Verified:
April 2023
Layout table for additional information
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Layout table for MeSH terms
CarcinomaLung NeoplasmsSarcomaGlioblastomaSmall Cell Lung CarcinomaNasopharyngeal CarcinomaCholangiocarcinomaSquamous Cell Carcinoma of Head and NeckCarcinoma, Ovarian EpithelialNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by Site
Lung DiseasesRespiratory Tract DiseasesCarcinoma, BronchogenicBronchial NeoplasmsCarcinoma, Squamous CellAdenocarcinomaOvarian NeoplasmsEndocrine Gland NeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, Female
Source: View full study details on ClinicalTrials.gov
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. By listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
