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.
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.
Patient with urinary incontinence.
Patient treated with anticoagulant or platelet antiaggregant therapies.
Symptoms of urine infection.
Patient with urethral stenosis.
Single group
ATO-101™
DrugThe study drug: \[211At\]At-Girentuximab (ATO-101™) is administered via intravesical instillation
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.
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.
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This trial is not recruiting at the moment. You can still explore other options:
