Non-muscle-invasive Bladder Cancer, Non-Muscle Invasive Bladder Cancer (&Amp;#34;NMIBC&Amp;#34;) Unresponsive/Intolerant to BCG, NMIBC, Non-Muscle Invasive Bladder Carcinoma, Non-Muscle Invasive Bladder Neoplasms, Non-Muscle Invasive Bladder Urothelial Carcinoma, Urothelial Carcinoma Bladder
Conditions
Keywords
NMIBC, TURBT, Intramural, AU-011, Belzupacap Sarotalocan, Intratumoral, urothelial, bladder cancer, bel-sar
Brief 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.
Detailed description
Aura is enrolling participants with urothelial carcinoma to evaluate the safety, technical feasibility, and preliminary efficacy of bel-sar. The goal is to achieve the trial objectives with minimal disruption to the standard of care (SoC) of the treating Investigator.
Interventions
DRUGAU-011
Administration of AU-011 intratumorally and intramurally
COMBINATION_PRODUCTAU-011 in Combination with Medical Laser Adminstration
AU-011 Intratumorally and Intramurally
COMBINATION_PRODUCTAU-011 in Combination with Medical Laser Administration
AU-011 Intratumorally
Sponsors
Aura Biosciences
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. 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 required. Participants with recurrent NMIBC must have a current lesion that clinically appears to be NMIBC with histopathologic confirmation based on TURBT or biopsy within the last 24 months). For Cohorts 4d, 4e, 4g and 4h, a diagnosis of LG IR NMIBC (according to AUA risk classification guidelines) is required, specifically: * 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 2. Have no evidence of current or prior metastatic urothelial carcinoma 3. Adequate bone marrow, renal, and hepatic function
Exclusion criteria
1. Any additional malignancy that requires active treatment, unless deemed appropriate after discussion by the Investigator with the trial's Medical Monitor. 2. 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. 3. 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. 4. 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. 5. Chronic active hepatitis B or C and HIV.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety of AU-011: Incidences of SAEs and DLTs | up to 12 months | Incidence and severity of treatment-related adverse events \[time frame 12 months\], serious adverse events \[time frame 12 months\], and incidence of dose-limiting toxicities \[time frame 14 days\] |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Complete response (CR) rate | at the 3-month time point and at TURBT | for all cohorts |
| Duration of response (DoR) | 12 months | In participants who achieve CR |
| Durable CR rate | 6-, 9-, and 12-month follow-up | Proportion of participants maintaining a CR after achieving a CR |
| Recurrence-free survival (RFS) | 12 mos | Participants in neoadjuvant cohorts |
Countries
Australia, United States
Contacts
Primary ContactMedical Monitor
Outcome results
None listed