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

June 4, 2026 updated by: Institut Cancerologie de l'Ouest

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

24

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
    • Loire Atlantique
      • Saint-Herblain, Loire Atlantique, France, 44800

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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™.

Exclusion Criteria:

  • Patient with urinary incontinence.
  • Patient treated with anticoagulant or platelet antiaggregant therapies.
  • Symptoms of urine infection.
  • Patient with urethral stenosis.
  • Patient with valvular heart disease.
  • No history of congestive heart failure.
  • Known hypersensitivity to Girentuximab.
  • Exposure to any experimental diagnostic or therapeutic drug within 30 days prior the date of planned administration of ATO-101™.
  • 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 in past 3 years.
  • Prior chemotherapy, radiotherapy (other than short cycle of palliative radiotherapy), immunotherapy within 21 days of ATO-101™ administration.
  • Pregnant or likely to be pregnant or nursing patient.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ATO-101™
[211At]At-Girentuximab (ATO-101™) intravesical administration
Drug: ATO-101™
The study drug: [211At]At-Girentuximab (ATO-101™) is administered via intravesical instillation
Other Names:
  • [211At]At-Girentuximab

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To determine the Maximum Tolerated Dose (MTD) of ATO-101™.
Time Frame: 15 days
The primary endpoint is the occurrence of dose-limiting toxicities (DLTs) during the DLT observation period.
15 days
To determine the Recommended Dose for Expansion (RDE) of ATO-101™.
Time Frame: 15 days
The primary endpoint is the occurrence of dose-limiting toxicities (DLTs) during the DLT observation period.
15 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut Cancerologie de l'Ouest

Investigators

  • Principal Investigator: Caroline ROUSSEAU, MD, PhD, Institut de Cancérologie de l'OUEST _ ICO

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2027

Primary Completion (Estimated)

January 1, 2029

Study Completion (Estimated)

January 1, 2030

Study Registration Dates

First Submitted

November 19, 2025

First Submitted That Met QC Criteria

November 28, 2025

First Posted (Actual)

December 3, 2025

Study Record Updates

Last Update Posted (Actual)

June 8, 2026

Last Update Submitted That Met QC Criteria

June 4, 2026

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ICO-2023-18

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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