Evaluation of Safety, Tolerability and Response of ATO-101™ in Patients With Non-Muscle-Invasive Bladder Cancer (PERSEVERANCE EU)

NCT ID: NCT07260162

Last Updated: 2025-12-03

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-02-28
• Study Completion Date: 2028-08-31

Brief Summary

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.

Conditions

Bladder Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ATO-101™

\[211At\]At-Girentuximab (ATO-101™) intravesical administration

Group Type: EXPERIMENTAL

ATO-101™

Intervention Type: DRUG

The study drug: \[211At\]At-Girentuximab (ATO-101™) is administered via intravesical instillation

Interventions

ATO-101™

The study drug: \[211At\]At-Girentuximab (ATO-101™) is administered via intravesical instillation

Intervention Type: DRUG

Other Intervention Names

[211At]At-Girentuximab

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institut Cancerologie de l'Ouest

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Caroline ROUSSEAU, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Institut de Cancérologie de l'OUEST _ ICO

Locations

Institut de Cancérologie de l'Ouest

Saint-Herblain, Loire Atlantique, France

Countries

France

Central Contacts

Caroline ROUSSEAU, MD, PhD

Role: CONTACT

caroline.rousseau@ico.unicancer.fr

+33 2 40 67 99 00

Nadia ALLAM, PhD

Role: CONTACT

nadia.allam@ico.unicancer.fr

+33 2 40 67 99 00

Facility Contacts

Caroline ROUSSEAU, MD, PhD

Role: primary

caroline.rousseau@ico.unicancer.fr

+33 2 40 67 99 00

Other Identifiers

ICO-2023-18

Identifier Type: -

Identifier Source: org_study_id