NCT07260162Not yet recruitingPhase 1

Evaluation of ATO-101™ in Patients With Non-Muscle-Invasive Bladder Cancer (PERSEVERANCE EU)

A First In Human Phase I Trial Evaluating Safety, Tolerability and Response of [211At]At-Girentuximab (ATO-101™) in Patients With Non-Muscle-Invasive Bladder Cancer Refractory to Standard Treatment

Source: ClinicalTrials.gov · Last updated 8 Jun 2026

Brief summary (registry, in English)

Non-Muscle-Invasive Bladder cancer (NMIBC) tumours often recur despite TransUrethral Resection of Bladder (TURB) and Bacillus Calmette-Guerin (BCG) intravesical instillations, and have no effective conservative treatment options. Alpha emitters like Astatine-211 (211At), due to their short path and short half-life, show promise for superficial targets such as NMIBC. Carbonic anhydrase IX (CAIX), overexpressed in 70-90% of NMIBC cases but absent in healthy tissues, is an ideal target. A clinical feasibility Positron emission tomography-computed tomography (PET/CT) imaging study (Pertinence, NCT04897763) was conducted at Institut de cancérologie Ouest (ICO) in six patients using Girentuximab labelled with Zirconium-89 (\[89Zr\]Zr-girentuximab). It demonstrated successful tracer targeting and no radioactive leakage beyond the bladder following intravesical instillation. The study also confirmed the absence of toxicity, contamination, or significant additional staff radiation exposure. ATO-101™ (\[²¹¹At\]At-girentuximab) could enable localised tumour destruction while preserving the bladder in patients with BCG-unresponsive NMIBC. The ongoing First In Human (FIH) study evaluate the safety of ATO-101™ in patients with BCG-unresponsive NMIBC.

Status (registry): Not yet recruiting
Phase (registry): Phase 1
Study type: Interventional
Enrollment: 24 (estimated)
First submitted: 19 Nov 2025
Start date: Jan 2027
Primary completion date: Jan 2029
Lead sponsor: Institut Cancerologie de l'Ouest
Diseases: Bladder cancer
NCT number: NCT07260162

What you commit to

Study type: Interventional · Phase 1
Planned participants: 24
From Jan 2027 to the primary completion date, Jan 2029
1 site in 1 country
Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

Exposure to any experimental diagnostic or therapeutic drug within 30 days prior the date of planned administration of ATO-101™.
Concomitant cancer in the past 5 years except cutaneous cancers (except melanoma) and in situ carcinoma in past 3 years.
Prior chemotherapy, radiotherapy (other than short cycle of palliative radiotherapy), immunotherapy within 21 days of ATO-101™ administration.

Other illness

Symptoms of urine infection.
Patient with valvular heart disease.
No history of congestive heart failure.
Known hypersensitivity to Girentuximab.
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.

Lab values

Patient treated with anticoagulant or platelet antiaggregant therapies.

Other

Patient with urinary incontinence.
Patient with urethral stenosis.
Pregnant or likely to be pregnant or nursing patient.

Who the study is looking for

Performance Status (PS): 0 or 1.
Patient experiencing relapse following standard treatment (BCG therapy with or without Mitomycin), before radical surgery which is being considered as a therapeutic option.
Clinical evidence of NMIBC based on cystoscopy and proven histologically of papillary tumours.
Histologically confirmed bladder cancer patients relapsing without muscle invasion.
Negative serum/urine pregnancy test prior to ATO-101™ administration for female patient of childbearing potential.
Consent to use a contraception method for at least 3 months after administration of ATO-101™.
Adequate organ function confirmed by laboratory tests results allowing for safe administration of ATO-101™.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

Site	City	Country	Site status
Institut de Cancérologie de l'Ouest Coordinator of this site? Confirm its status	Saint-Herblain	France	Unknown status

This page is information, not medical advice. Discuss any trial with your doctor.