Bladder CancerPhase 1PERSEVERANCENCT07260162
Evaluation of ATO-101™ in Patients With Non-Muscle-Invasive Bladder Cancer (PERSEVERANCE EU)
A Phase 1 study testing ATO-101™ in people with Bladder Cancer, run by Institut Cancerologie de l'Ouest at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bladder Cancer
- What is being tested?
- ATO-101™
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2027to Jan 2030
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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™.
Who cannot join
- 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.
Show all 12Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
Institut de Cancérologie de l'Ouest
Saint-Herblain, Loire Atlantique, 44800
Caroline ROUSSEAU, MD, PhD, +33 2 40 67 99 00, caroline.rousseau@ico.unicancer.fr
About this study
Official title: 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.
Read more
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
- Being tested
- ATO-101™
- Keywords
- Non-Muscle-Invasive Bladder cancer (NMIBC), Girentuximab, Astatine 211, Phase I, First In Human (FIH), Carbonic anhydrase IX (CAIX), Intravesical instillation, [211At]At-Girentuximab, ATO-101™
- Medical subject headings
- Urinary Bladder Neoplasms, Non-Muscle Invasive Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ATO-101™Drug
Also called [211At]At-Girentuximab
The study drug: [211At]At-Girentuximab (ATO-101™) is administered via intravesical instillation
| Study group | Role | What they receive |
|---|---|---|
| ATO-101™ | Experimental | [211At]At-Girentuximab (ATO-101™) intravesical administration Receives: Drug: ATO-101™ |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the Maximum Tolerated Dose (MTD) of ATO-101™.
The primary endpoint is the occurrence of dose-limiting toxicities (DLTs) during the DLT observation period.
Measured: 15 days
To determine the Recommended Dose for Expansion (RDE) of ATO-101™.
The primary endpoint is the occurrence of dose-limiting toxicities (DLTs) during the DLT observation period.
Measured: 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2025
- Study startJan 2027 (estimated)
- Primary completionJan 2029 (estimated)
- Study completionJan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- ATO-101™ is an anti-CA-IX antibody (Girentuximab) radiolabeled with an alpha-emitting radionuclides (astatine-211)
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut Cancerologie de l'Ouest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Caroline ROUSSEAU, MD, PhD, Principal investigator, Institut de Cancérologie de l'OUEST _ ICO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07260162
- Sponsor's protocol ID
- ICO-2023-18
- Acronym
- PERSEVERANCE
- Status last verified
- Dec 2025
- First submitted
- 19 Nov 2025
- Last updated
- 8 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07260162
- Acronym / sponsor ID
- PERSEVERANCE / ICO-2023-18
- Conditions
- Bladder Cancer
- Keywords
- Non-Muscle-Invasive Bladder cancer (NMIBC), Girentuximab, Astatine 211, Phase I, First In Human (FIH), Carbonic anhydrase IX (CAIX), Intravesical instillation, [211At]At-Girentuximab
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Institut Cancerologie de l'OuestUniversity, hospital or other
- Study start
- Jan 2027 (estimated)
- Primary completion
- Jan 2029 (estimated)
- Study completion
- Jan 2030 (estimated)
- First posted
- 3 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- ATO-101™ is an anti-CA-IX antibody (Girentuximab) radiolabeled with an alpha-emitting radionuclides (astatine-211)
| Arm | Type | Receives |
|---|---|---|
| ATO-101™ | Experimental | Drug: ATO-101™[211At]At-Girentuximab (ATO-101™) intravesical administration |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ATO-101™Also: [211At]At-GirentuximabThe study drug: [211At]At-Girentuximab (ATO-101™) is administered via intravesical instillation | Drug | ATO-101™ |
Primary outcome
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2026.
Related trials for Bladder Cancer
RecruitingPhase 2/3
Testing the Role of DNA Released From Tumor Cells Into the Blood in Guiding the Use of Immunotherapy After Surgical Removal of the Bladder, Kidney, Ureter, and Urethra for Urothelial Cancer Treatment, MODERN Study
Muscle Invasive Bladder Urothelial Carcinoma, Muscle Invasive Renal Pelvis Urothelial Carcinoma
RecruitingPhase 3
A Clinical Trial of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) and Pembrolizumab (MK-3475A) in Participants With Bladder Cancer (MK-2870-055)
Bladder Cancer
Active, not recruitingPhase 2/3
A Study of CTX-009 in Combination With Paclitaxel in Adult Patients With Unresectable Advanced, Metastatic or Recurrent Biliary Tract Cancers (COMPANION-002)
Biliary Tract Cancer, Cholangiocarcinoma
Recruiting
Effect of Cyclic Sighing Breathing Exercise on CRBD, Pain, and Sleep Quality in Patients Undergoing TUR
Transurethral Resection of Bladder Tumor, Transurethral Resection of the Prostate (TURP)
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Caroline ROUSSEAU, MD, PhD principal investigator
Institut de Cancérologie de l'OUEST _ ICO
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ATO-101™ in people with Bladder Cancer, run by Institut Cancerologie de l'Ouest at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Caroline ROUSSEAU, MD, PhD (+33 2 40 67 99 00, caroline.rousseau@ico.unicancer.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine the Maximum Tolerated Dose (MTD) of ATO-101™. (time frame: 15 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2026.