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NCT05483868Phase 1Active, not recruiting

A Phase 1, Open-label Trial of Belzupacap Sarotalocan (AU-011) in Bladder Cancer

Study Summary

The main objectives of this study are to determine the feasibility and safety of Belzupacap Sarotalocan (AU-011, bel-sar) treatment of bladder cancer utilizing focal injections with or without laser application.

View on ClinicalTrials.gov ↗
Study Details
Enrollment55 participants
Primary Completion2027-03
Lead SponsorAura Biosciences
Data Retrieved2026-10-14
What This Trial Means for Biotech Investors
Trial Phase Context

Phase 1 trials primarily test safety and dosing in a small number of participants (typically 20–100). Results do not yet speak to efficacy. FDA approval is typically many years away from this stage.

Status & Expected Data

Enrollment is complete. The trial is in its follow-up or data collection phase — a readout may occur on or near the primary completion date.

Primary completion: 2027-03
Enrolled: 55 participants
Sponsor Catalyst Profile

Aura Biosciences (AURA) is the sponsoring company for this trial. BiotechSign currently grades this company F (32/100) based on composite catalyst signals across its full pipeline. This trial is one data point in that overall catalyst picture.

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