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New treatment option for Non-muscle-invasive Bladder Cancer
Official title A Phase 1, Open-label Trial of Belzupacap Sarotalocan (AU-011) in Bladder Cancer
ClinicalTrials.gov ID: NCT05483868
What this study is testing
What is AU-011?
AU-011 is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for non-muscle-invasive bladder cancer.
Also referred to as belzupacap sarotalocan.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Meet the following histopathologic requirements for urothelial carcinoma:
- For Cohorts 1b, 4a-c: histopathological diagnosis of NMIBC (any grade) is required. For participants with first diagnosis of NMIBC, confirmation of...
- Multifocal LG Ta; OR
- Solitary LG Ta \>3 cm; OR
- Low-grade Ta with prior recurrence(s) within 1 year. For Cohorts 4f and 4i, a diagnosis of HR NMIBC (according to AUA risk classification guidelines)...
You likely can't join if
- Any additional malignancy that requires active treatment, unless deemed appropriate after discussion by the Investigator with the trial's Medical...
- 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...
- Active bacterial, fungal, or viral infections - all prior infections must have resolved following optimal therapy and subject must be off all...
- Active autoimmune disease, chronic inflammatory condition, or other conditions (like solid organ transplant or bone marrow allograft) requiring...
- Chronic active hepatitis B or C and HIV.
See the full eligibility criteria
- Meet the following histopathologic requirements for urothelial carcinoma:
- For Cohorts 1b, 4a-c: histopathological diagnosis of NMIBC (any grade) is required. For participants with first diagnosis of NMIBC, confirmation of urothelial carcinoma by recent biopsy (≤6 months of Screening Visit) is...
- Multifocal LG Ta; OR
- Solitary LG Ta \>3 cm; OR
- Low-grade Ta with prior recurrence(s) within 1 year. For Cohorts 4f and 4i, a diagnosis of HR NMIBC (according to AUA risk classification guidelines) is required, specifically:
- Ta HG papillary disease with or without CIS; OR
- T1 papillary disease with or without CIS
- Participants may be BCG-naïve or may have received prior treatment with BCG for HR or IR NMIBC (BCG-exposed, BCG-failed, BCG-intolerant)
- BCG-refractory participants are excluded. BCG-refractory is defined by the following:
- Persistent HG disease at 6 months following adequate BCG (defined as ≥5/6 induction instillations and ≥2 additional doses, either from re-induction or maintenance), OR
- HG T1 disease at first evaluation (3 months) after BCG, OR
- Persistent CIS that remains despite a second BCG course, OR
- Disease progression in stage or grade during BCG therapy, including maintenance
- Have no evidence of current or prior metastatic urothelial carcinoma
- Adequate bone marrow, renal, and hepatic function
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Little Rock, Arkansas, United States
- Los Angeles, California, United States
- Santa Monica, California, United States
- The Bronx, New York, United States
- Myrtle Beach, South Carolina, United States
- Nashville, Tennessee, United States
- Dallas, Texas, United States
- Houston, Texas, United States
- San Antonio, Texas, United States
- Westmead, New South Wales, Australia
- Heidelberg, Victoria, Australia
- Langwarrin, Victoria, Australia
- Parkville, Victoria, Australia
- Nedlands, Western Australia, Australia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Little Rock, Arkansas, United States; Los Angeles, California, United States; Santa Monica, California, United States; The Bronx, New York, United States; Myrtle Beach, South Carolina, United States; Nashville, Tennessee, United States and 8 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.