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

Colorectal Cancer Clinical Trial

Official title:

Study of 89Zr-girentuximab for PET Imaging of Solid Tumors Likely to Express High Levels of CAIX

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05563272
• Other study ID #: 89Zr-TLX250-005
• Status: Recruiting
• Phase: Phase 2
• Start date: June 6, 2023
• Est. completion date: December 29, 2025

Study information

• Verified date: January 2024
• Source: Telix International Pty Ltd
• Contact: Kavita Vadali
• Phone: +61 3 9093 3808
• Email: global-clinicaltrials[@]telixpharma.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 29, 2025
• Est. primary completion date: December 8, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 95 Years

Eligibility

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).

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
United States	Austin Radiological Association (ARA)	Austin	Texas
United States	University Hospitals	Cleveland	Ohio
United States	Biogenix Molecular, LLC	Miami	Florida
United States	Carilion Clinic	Roanoke	Virginia
United States	Inland Imaging	Spokane	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Telix International Pty Ltd

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Qualitative assessment of 89Zr-girentuximab uptake within individual tumor deposits	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.	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
Primary	Quantitative assessment of 89Zr-girentuximab uptake within individual tumor deposits	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.	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
Secondary	To evaluate safety parameter of Heart rate in patients administered with 89Zr-girentuximab	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	Patients will be evaluated for the period up to imaging following administration of 89Zr-girentuximab, at most 7 days.
Secondary	To evaluate safety parameter of blood pressure in patients administered with 89Zr-girentuximab.	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	Patients will be evaluated for the period up to imaging following administration of 89Zr-girentuximab, up to 7 days.
Secondary	To evaluate safety parameter related to Liver function in patients administered 89Zr-girentuximab	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.	Patients will be evaluated for the period up to imaging following administration of 89Zr-girentuximab, up to 7 days.
Secondary	To evaluate safety parameter related to Renal function in patients administered 89Zr-girentuximab	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.	Patients will be evaluated for the period up to imaging following administration of 89Zr-girentuximab, up to 7 days.
Secondary	To evaluate safety parameter related to Full Blood Count in patients administered 89Zr-girentuximab	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.	Patients will be evaluated for the period up to imaging following administration of 89Zr-girentuximab, up to 7 days.