Assessment of Safety, Tolerability, Radiation Dosimetry, Imaging Properties of 89Zr-girentuximab in Patients With NMIBC

NCT04897763 | Completed Early Phase 1 Results

• 1 other identifier: ICO-2021-03
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Bladder Cancer

Keywords

Non-muscle-invasive bladder cancer (NMIBC); 89Zr-Girentuximab PET; pilot study; 89Zr-TLX250 PET; carbonic anhydrase IX (CAIX)

Outcome Measures

Primary Outcomes (2)

• Number of Participants With Uptake Spot in 89Zr-girentuximab PET/CT Images

  The presence or absence of uptake spot in bladder wall of 89Zr-girentuximab bladder and whole body PET/CT Images.

  3 days

• Number of Patients With Positive and Negative 89Zr-girentuximab Blood Dosing

  89Zr-girentuximab activity dosing in blood is measured. The number of patients with Positive and negative 89Zr-girentuximab Blood dosing is evaluated.

  2 days

Secondary Outcomes (5)

• Number of Participants With Serious Adverse Events

  30 days

• Number of Patients With Positive and Negative CA-IX Expression in Tumor Cells

  3 months

• Number of Participants With Adverse Events Related to 89Zr-girentuximab

  3 days

• Radiation Protection Management

  3 days

• Radiation Protection Management

  1 day

Study Arms (1)

89Zr-TLX250

EXPERIMENTAL

89Zr-TLX250 (89Zr-girentuximab) PET/CT performed for all aptients

Drug: 89Zr-TLX250

Interventions

89Zr-TLX250 DRUG

89Zr-TLX250 (89Zr-girentuximab) PET/CT performed for all aptients

Also known as: [89Zr]Zr-girentuximab

89Zr-TLX250

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Institut Cancerologie de l'Ouest: lead
• ATONCO: collaborator

Study Sites (1)

Institut de cancerologie de l'Ouest

Saint-Herblain, 44805, France

Location

Related Links

• PubMed

MeSH Terms

Conditions

Urinary Bladder Neoplasms; Non-Muscle Invasive Bladder Neoplasms

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Results Point of Contact

• Title: Dr Caroline ROUSSEAU
• Organization: Institut de cancérologie de l'Ouest

caroline.rousseau@ico.unicancer.fr

+33 2 40 67 99 31

Study Officials

• Caroline ROUSSEAU, MD, PhD

  Institut de Cancerologie de l'Ousest - ICO

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Monocentric, open prospective study

Study Record Dates

• First Submitted: May 17, 2021
• First Posted: May 24, 2021
• Study Start: December 15, 2021
• Primary Completion: August 24, 2022
• Study Completion: September 26, 2022
• Last Updated: January 7, 2026
• Results First Posted: January 7, 2026

Record last verified: 2025-09

Locations

FR (1)