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

Sponsor
Institut Cancerologie de l'Ouest
Study ID
NCT07260162
Phase
PHASE1
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

First listed
Dec 3, 2025
Start date
Jan 31, 2027
Status verified
Dec 2025
Primary completion
Jan 31, 2029
Completion
Jan 31, 2030

Study Design

Enrollment
24 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

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

Primary Outcome Measure

To determine the Maximum Tolerated Dose (MTD) of ATO-101™. [ Time Frame: 15 days ]

Central Contacts

Find similar trials

Nationwide
Bladder cancer trialsOncology trialsUrology trials

Related Studies