Active, not recruiting
Phase 1
A Phase 1, Open-label Trial of Belzupacap Sarotalocan (AU-011) in Bladder Cancer
Condition(s) studied
Non-muscle-invasive Bladder CancerNMIBCNon-Muscle Invasive Bladder CarcinomaNon-Muscle Invasive Bladder NeoplasmsNon-Muscle Invasive Bladder Urothelial CarcinomaUrothelial Carcinoma Bladder
Investigational drug(s) / intervention(s)
AU-011AU-011 in Combination with Medical Laser AdminstrationAU-011 in Combination with Medical Laser Administration
AU-011: Administration of AU-011 intratumorally and intramurally
AU-011 in Combination with Medical Laser Adminstration: AU-011 Intratumorally and Intramurally
AU-011 in Combination with Medical Laser Administration: AU-011 Intratumorally
Study 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.
Eligibility
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.
Primary outcome measure(s)
- 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 \[time frame 14 days\]
Trial sites (19)
| Facility | City | Region | Status |
| Arkansas Urology |
Little Rock |
Arkansas |
|
| Tower Urology |
Los Angeles |
California |
|
| Saint John's Cancer Institute |
Santa Monica |
California |
|
| Colorado Clinical Research |
Lakewood |
Colorado |
|
| Montefiore Medical Center |
The Bronx |
New York |
|
| UPMC Hillman Cancer Center |
Pittsburgh |
Pennsylvania |
|
| Carolina Urologic Research Center |
Myrtle Beach |
South Carolina |
|
| Urology Associates, P.C. |
Nashville |
Tennessee |
|
| Urology Clinics of North Texas |
Dallas |
Texas |
|
| Baylor College of Medicine |
Houston |
Texas |
|
| The University of Texas San Antonio |
San Antonio |
Texas |
|
| Urology San Antonio/USA Clinical Trials |
San Antonio |
Texas |
|
| The Urology Place |
San Antonio |
Texas |
|
| Westmead Private Hospital |
Westmead |
New South Wales |
|
| Austin Health |
Heidelberg |
Victoria |
|
| Warringal Private Hospital |
Heidelberg |
Victoria |
|
| Penninsula Private Hospital |
Langwarrin |
Victoria |
|
| The Royal Melbourne Hospital |
Parkville |
Victoria |
|
| Hollywood Private Hospital |
Nedlands |
Western Australia |
|