Assessment of safEty, Tolerability, Radiation Dosimetry, and Imaging Properties of 89Zr-labeled giRenTuximab (89Zr-Girentuximab) in patIents With Non-musclE-iNvasive Bladder CancEr (NMIBC)

• Status: Not yet recruiting
• Trial end date: 2022-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Institut Cancerologie de l'Ouest
• Collaborator: ATONCO

Criteria

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.