TERMINATED

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

Conditions

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 Gastric Adenocarcinoma Malignant Mesothelioma (MM)Von Hippel Lindau Bladder Cancer Bladder Urothelial Carcinoma

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Phase 2, Multicenter, Open-Label Study of 89Zr-girentuximab for PET/CT Imaging of Tumors Likely to Express High Levels of CAIX

Quick Facts

Study Start:2023-06-06

Study Completion:2025-05-09

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:TERMINATED

Study ID

NCT05563272

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 95 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Written and voluntarily given Informed Consent. 2. Male or female ≥18 years of age at time of consent. 3. Have the capacity to understand the study and be willing and able to comply with all protocol requirements. 4. Participants must have proven tumors of the following types, but not limited to: * Cervical cancer; * Colorectal cancer; * Esophageal SCC and esophageal/esophagogastric junction adenocarcinoma; * Gastric adenocarcinoma; * GBM; * Head and neck SCC and nasopharyngeal carcinoma; * cholangiocarcinoma and hepatocellular carcinoma; * non-small cell lung cancer; * small cell lung cancer; * epithelial ovarian carcinoma; * pancreatic ductal adenocarcinoma; * Soft tissue sarcoma; * malignant mesothelioma; * confirmed diagnosis of VHL disease with VHL germline alteration and at least one VHL-related lesion. 5. 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); 6. 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; 7. 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: * Be post-menopausal, defined as more than 50 years of age and amenorrheic for at least 12 months since cessation of all exogenous hormonal treatments; * Be a woman under 50 years of age and considered postmenopausal given amenorrhea for 12 months or more since cessation of exogenous hormonal treatments and having luteinizing hormone (LH) and follicle-stimulating hormone (FSH) levels in the post-menopausal range by institutional SOC; * Have documentation of irreversible surgical sterilization by hysterectomy, bilateral oophorectomy, or bilateral salpingectomy but not tubal ligation; and 8. Have consented to practice highly effective method of contraception until a minimum of 42 days after 89Zr-girentuximab administration 1. 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); 2. Have been exposed to any CAIX targeting compound (diagnostic/therapeutic) in the prior 3 months; 3. 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; 4. 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; 5. Have a mental impairment that may compromise the ability to give Informed Consent and comply with the requirements of the study; 6. 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); 7. Be a female who is pregnant or breastfeeding; 8. Have a known allergy, hypersensitivity, or intolerance to girentuximab, desferrioxamine (DFO), or any of the components of the investigational agent; 9. Have renal insufficiency with a glomerular filtration rate (GFR) ≤45 milliliters/min/1.73m2 10. Be a vulnerable participant (e.g., being in detention).	Pregnancy or breastfeeding Severe psychiatric disorders Active substance abuse Unstable medical conditions Inability to comply with study requirements

Inclusion Criteria

Exclusion Criteria

1. Written and voluntarily given Informed Consent.
2. Male or female ≥18 years of age at time of consent.
3. Have the capacity to understand the study and be willing and able to comply with all protocol requirements.
4. Participants must have proven tumors of the following types, but not limited to:
* Cervical cancer;
* Colorectal cancer;
* Esophageal SCC and esophageal/esophagogastric junction adenocarcinoma;
* Gastric adenocarcinoma;
* GBM;
* Head and neck SCC and nasopharyngeal carcinoma;
* cholangiocarcinoma and hepatocellular carcinoma;
* non-small cell lung cancer;
* small cell lung cancer;
* epithelial ovarian carcinoma;
* pancreatic ductal adenocarcinoma;
* Soft tissue sarcoma;
* malignant mesothelioma;
* confirmed diagnosis of VHL disease with VHL germline alteration and at least one VHL-related lesion.
5. 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);
6. 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;
7. 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:
* Be post-menopausal, defined as more than 50 years of age and amenorrheic for at least 12 months since cessation of all exogenous hormonal treatments;
* Be a woman under 50 years of age and considered postmenopausal given amenorrhea for 12 months or more since cessation of exogenous hormonal treatments and having luteinizing hormone (LH) and follicle-stimulating hormone (FSH) levels in the post-menopausal range by institutional SOC;
* Have documentation of irreversible surgical sterilization by hysterectomy, bilateral oophorectomy, or bilateral salpingectomy but not tubal ligation; and
8. Have consented to practice highly effective method of contraception until a minimum of 42 days after 89Zr-girentuximab administration
1. 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);
2. Have been exposed to any CAIX targeting compound (diagnostic/therapeutic) in the prior 3 months;
3. 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;
4. 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;
5. Have a mental impairment that may compromise the ability to give Informed Consent and comply with the requirements of the study;
6. 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);
7. Be a female who is pregnant or breastfeeding;
8. Have a known allergy, hypersensitivity, or intolerance to girentuximab, desferrioxamine (DFO), or any of the components of the investigational agent;
9. Have renal insufficiency with a glomerular filtration rate (GFR) ≤45 milliliters/min/1.73m2
10. Be a vulnerable participant (e.g., being in detention).

Pregnancy or breastfeeding
Severe psychiatric disorders
Active substance abuse
Unstable medical conditions
Inability to comply with study requirements

Contacts and Locations

Study Locations (Sites)

University of California, Los Angeles(UCLA)

Los Angeles, California, 90095

United States

Biogenix Molecular, LLC

Miami, Florida, 33165

United States

Massachusetts General Hospital

Boston, Massachusetts, 02114

United States

Munson Medical Center

Traverse City, Michigan, 49684

United States

University Hospitals Cleveland Medical Center (UHCMC)

Cleveland, Ohio, 44106

United States

Kettering Health Research Institute

Kettering, Ohio, 45429

United States

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15219

United States

Austin Radiological Association (ARA)

Austin, Texas, 78705

United States

Carilion Clinic

Roanoke, Virginia, 24018

United States

Inland Imaging

Spokane, Washington, 99208

United States

Collaborators and Investigators

Sponsor: Telix Pharmaceuticals (Innovations) Pty Ltd

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-06-06

Study Completion Date2025-05-09

Study Record Updates

Study Start Date2023-06-06

Study Completion Date2025-05-09

Terms related to this study

Additional Relevant MeSH Terms

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
Gastric Adenocarcinoma
Malignant Mesothelioma (MM)
Von Hippel Lindau
Bladder Cancer
Bladder Urothelial Carcinoma