A Pilot Open-label, Feasibility Study to Assess safEty, Tolerability, Radiation Dosimetry, and Imaging Properties of 89Zr-labeled giRenTuximab (89Zr-Girentuximab) in patIents With Non-musclE-iNvasive Bladder CancEr (NMIBC)

ICO-2021-03

The purpose of this study is to evaluate the use of 89Zr-labeled girentuximab (89Zr-TLX250) as a novel, carbonic anhydrase IX (CAIX) targeted PET/CT radiopharmaceutical for the imaging of Non-muscle-invasive bladder cancer (NMIBC) patients.

2021-10-01

2022-08-24

2022-09-26

Completed

Early phase I

6

Inclusion Criteria: * Written informed consent obtained from the patient prior to performing any protocol-related procedures, including screening evaluations. * Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures. * Female or male, Age ≥ 18 years at time of study entry. * Performance Status: 0 or 1. * Clinical evidence of NMIBC based on cystoscopy and proven histologically of papillary tumors. * Histologically-confirmed pTa Grade 3 or pT1 Grade 3 bladder cancer patients relapsing without muscle invasion. * Negative sterile Urine cytobacteriological testing at baseline (T0). * Consent to use a contraception method for at least 30 days after administration of 89Zr-girentuximab. * Patient has valid health insurance. Exclusion Criteria: * Patient with urinary incontinence. * Known hypersensitivity to girentuximab. * Exposure to any experimental diagnostic or therapeutic drug within 30 days prior the date of planned administration of 89Zr-girentuximab * Exposure to any radiopharmaceutical within 30 days (corresponding to 10 half-lives of Zr-89) prior to the administration of 89Zr-girentuximab * Patients suffering from a bladder cancer at stage pT2, pT3 or pT4 * Serious non-malignant disease that may interfere with the objectives of the study or with the safety or compliance of the patient; as judged by the investigator * Concomitant cancer in the past 5 years except cutaneous cancers (except melanoma) and in situ carcinoma * Prior chemotherapy, radiotherapy (other than short cycle of palliative radiotherapy), immunotherapy within 21 days of 89Zr-girentuximab administration * Patients with known human immunodeficiency viruses (HIV), Hepatitis B virus (HBV) and Hepatitis C Virus (HCV) infections, * Pregnant or likely to be pregnant or nursing patient. * Mental impairment that may compromise the ability to give informed consent and comply with the requirements of the study * Persons deprived of their liberty, under a measure of safeguard of justice, under guardianship or placed under the authority of a guardian.

{'studyType': 'INTERVENTIONAL', 'phases': ['EARLY_PHASE1'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Monocentric, open prospective study', 'primaryPurpose': 'DIAGNOSTIC', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 6, 'type': 'ACTUAL'}}

2023-02-21