Phase 1 Bladder Cancer Trial, Recruiting
Who may be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who might be able to join this trial:
- People who have been diagnosed with a type of bladder cancer called non-muscle-invasive bladder cancer (NMIBC), confirmed by a tissue sample taken during a procedure or biopsy, with specific requirements depending on which group (cohort) of the trial applies to them (confirm with trial site)
- For certain groups, people with a low-grade, intermediate-risk form of NMIBC — for example, cancer found in multiple spots, a single tumour larger than 3 cm, or low-grade cancer that has come back within one year
- For other groups, people with a high-risk form of NMIBC, which may include certain tumour types with or without a related condition called CIS (carcinoma in situ)
- People who have never received a treatment called BCG, or who have received it previously but did not respond fully or could not tolerate it — as long as they do not meet the definition of "BCG-refractory" (confirm with trial site for the specific definition)
- People who have no current or past spread of bladder cancer to other parts of the body
- People whose bone marrow, kidneys, and liver are functioning well enough to meet the trial's health requirements
Who may not be able to join:
- People who have another cancer that currently requires active treatment, unless the trial's medical team reviews the situation and decides it is appropriate
- People who have taken an experimental drug or used an experimental medical device within the past 30 days (or longer, depending on the drug), or who are already taking part in another experimental trial
- People who currently have an active bacterial, fungal, or viral infection, or who are still taking antibiotic or antiviral medicines
- People who have an active autoimmune disease, a chronic inflammatory condition, or a condition such as an organ transplant or bone marrow transplant that requires ongoing use of medicines that suppress the immune system, including steroids
- People who have chronic active hepatitis B, hepatitis C, or HIV
- People whose NMIBC is classified as "BCG-refractory," meaning the cancer continued or worsened despite a full course of BCG treatment (confirm with trial site for the exact definition)
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
Contact this trial
Principal Investigator: Medical Monitor, Aura Biosciences
Phone: 617-500-8864
Australian sites
+61 4 1943 4636
+61 3 9496 4915
+61 456 359 569
+61 3 9788 3647
+61 3 9342 7294
+61 8 9346 6022
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
6 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
Safety of AU-011: Incidences of SAEs and DLTs
Can't join this trial?
Data last synced from ClinicalTrials.gov: 27 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.