A Phase 1, Open-label Trial of Belzupacap Sarotalocan (AU-011) in Bladder Cancer
← catalyst calendarNCT05483868 · readout ≤ 223 d
Sponsored by Aura Biosciences (industry) · AURA — their whole pipeline →.
Phase
Phase 1
Status
Active, not recruiting
Study type
Interventional
Design
Non randomized · None · Treatment
Enrollment
55estimated
Sites
19
Countries
Australia, United States
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2022-09-26 | actual | When the study began enrolling |
| Primary completion | Mar 2027 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Mar 2027 | estimated | The whole study's end, after follow-up |
| First posted | 2022-08-02 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-08-06 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- Non-muscle-invasive Bladder Cancer
- NMIBC
- Non-Muscle Invasive Bladder Carcinoma
- Non-Muscle Invasive Bladder Neoplasms
- Non-Muscle Invasive Bladder Urothelial Carcinoma
- Urothelial Carcinoma Bladder
Interventions
- Drug: AU-011 — also filed as belzupacap sarotalocan
- Combination product: AU-011 in Combination with Medical Laser Adminstration — also filed as belzupacap sarotalocan
- Combination product: AU-011 in Combination with Medical Laser Administration — also filed as belzupacap sarotalocan
Primary outcome
what the primary-completion date above is the date OFSafety of AU-011: Incidences of SAEs and DLTs
measured up to 12 months
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