Early Phase 1
N=6
Assessment of Safety, Tolerability, Radiation Dosimetry, Imaging Properties of 89Zr-girentuximab in Patients With NMIBC
Bladder Cancer
Bottom Line
View on ClinicalTrials.gov: NCT04897763 ↗Enrolled (actual)
6
Serious AEs
33.3%
Results posted
Jan 2026
Primary outcome: Primary: Number of Participants With Uptake Spot in 89Zr-girentuximab PET/CT Images — 1; 2; 3 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Early Phase 1
- Interventions
- 89Zr-TLX250 (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Institut Cancerologie de l'Ouest
- Primary completion
- Aug 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Uptake Spot in 89Zr-girentuximab PET/CT Images |
1; 2; 3 | — |
| PRIMARY Number of Patients With Positive and Negative 89Zr-girentuximab Blood Dosing |
1; 5 | — |
| SECONDARY Number of Participants With Serious Adverse Events |
1; 1; 4 | — |
| SECONDARY Number of Patients With Positive and Negative CA-IX Expression in Tumor Cells |
5; 1 | — |
| SECONDARY Number of Participants With Adverse Events Related to 89Zr-girentuximab |
1; 5 | — |
| SECONDARY Radiation Protection Management |
115 | — |
| SECONDARY Radiation Protection Management |
115 | — |
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.
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT04897763). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.