About this trial

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.

Eligibility criteria

Qualifiers

Multifocal LG Ta; OR

Solitary LG Ta >3 cm; OR

Low-grade Ta with prior recurrence(s) within 1 year.

Ta HG papillary disease with or without CIS; OR

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • AU-011
  • AU-011 in Combination with Medical Laser Adminstration
  • AU-011 in Combination with Medical Laser Administration

Treatment groups

55 Participants
are divided into 10 treatment groups

10

Treatment groups

See each treatment group below.

Locations

17
Australia
Westmead Private Hospital2145, WestmeadNew South Wales, Australia
Austin Health3084, HeidelbergVictoria, Australia
Warringal Private Hospital HeidelbergVictoria, Australia
Penninsula Private Hospital3910, LangwarrinVictoria, Australia

Sponsors and collaborators

Aura Biosciences

Lead sponsor