RecruitingPhase 1

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

United States55 participantsStarted 2022-09-26

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Meet the following histopathologic requirements for urothelial carcinoma:
✓. Have no evidence of current or prior metastatic urothelial carcinoma
✓. Adequate bone marrow, renal, and hepatic function

Exclusion criteria

✕. Any additional malignancy that requires active treatment, unless deemed appropriate after discussion by the Investigator with the trial's Medical Monitor.
✕. Used an investigational drug or medical device within 30 days or 5 half-lives (whichever is longer) of Visit 1 or be concurrently enrolled in another investigational trial.
✕. Active bacterial, fungal, or viral infections - all prior infections must have resolved following optimal therapy and subject must be off all systemic anti-infective agents.
✕. Active autoimmune disease, chronic inflammatory condition, or other conditions (like solid organ transplant or bone marrow allograft) requiring concurrent use of any systemic immunosuppressants or steroids.
✕. Chronic active hepatitis B or C and HIV.

What they're measuring

Safety of AU-011: Incidences of SAEs and DLTs

Timeframe: up to 12 months

Trial details

NCT IDNCT05483868

SponsorAura Biosciences

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-03

Contact for this trial

Medical Monitor

617-500-8864 clinical@aurabiosciences.com

View on ClinicalTrials.gov More Non-muscle-invasive Bladder Cancer trials