Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
AU-011 · 3 trials · 11 indications
B-Scan Ultrasonography
Fundus photos
Adverse Events
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 \[time frame 14 days\]
| Arm | Type | Description |
|---|---|---|
| 80 micrograms of bel-sar | EXPERIMENTAL | 1 Cycle AU-011 with a dose of 80 micrograms |
| 140 micrograms of bel-sar | EXPERIMENTAL | 1 Cycle AU-011 with a dose of 140 micrograms |
| 200 micrograms of bel-sar with one cycle | EXPERIMENTAL | 1 Cycle AU-011 with a dose of 200 micrograms |
| 200 micrograms of bel-sar with two cycles | EXPERIMENTAL | 2 Cycles AU-011 with a dose of 200 micrograms |
| Observational | NO_INTERVENTION | Subjects that meet trial inclusion, but do not meet criteria for enrollment into the bel-sar treatment cohorts, may be enrolled in this cohort. The observational cohort will not receive bel-sar treatment. |
| 40 micrograms of bel-sar with one cycle | EXPERIMENTAL | 1 Cycle AU-011 with a dose of 40 micrograms |
| 40 micrograms of bel-sar with two cycles | EXPERIMENTAL | 2 Cycles AU-011 with a dose of 40 micrograms |
| Cohort 1 AU-011& Laser | EXPERIMENTAL | Low dose of AU-011 + 1 laser application |
| Cohort 2 AU-011 & Laser | EXPERIMENTAL | Medium dose of AU-011 + 1 laser application |
| Cohort 3 AU-011 (belzupacap sarotalocan) & Laser | EXPERIMENTAL | Medium dose of AU-011 + 2 laser applications |
| Cohort 4 AU-011 & Laser | EXPERIMENTAL | Highest tolerated dose of AU-011 / laser applications from Cohorts 1 to 3 administered weekly for 2 treatments |
| Cohort 5 AU-011 & Laser | EXPERIMENTAL | AU-011/laser applications from Cohorts 1 to 3 administered weekly for 3 treatments. Up to 2 cycles of this regimen may be administered and subjects have the option of receiving a third cycle of treatment. |
| Cohort 6 AU-011 & Laser | EXPERIMENTAL | High dose of AU-011/laser applications administered weekly for 3 treatments and up to 3 cycles of treatment. |
| Focal injections of AU-011 prior to TURBT (1b) | EXPERIMENTAL | Intratumoral (50 μg) and intramural (50 μg) injection of AU-011 prior to the standard of care (TURBT) in patients with NMIBC. |
| Focal injections of AU-011 with laser application before TURBT (4a) | EXPERIMENTAL | Intratumoral (50 μg) and intramural (50 μg) injection of AU-011 with laser application before standard of care (TURBT) in patients with NMIBC. |
| Focal injection of AU-011 with laser application before TURBT (4b) | EXPERIMENTAL | Focal injection of AU-011 (100 μg) with laser application before standard of care (TURBT) in patients with NMIBC. |
| Focal injection of AU-011 with laser application before TURBT (4c) | EXPERIMENTAL | Focal injection of AU-011 (200 μg) with laser application before standard of care (TURBT) in patients with NMIBC. |
| Focal injection of AU-011 and laser application with option for TURBT (4d) | EXPERIMENTAL | Participants with intermediate-risk NMIBC will receive multiple treatment cycles of focal AU-011 (200 ug per lesion) with laser treatment and option for TURBT in patients with intermediate risk NMIBC. Participants will be evaluated for safety and response to AU-011 up to 12 months from initiation of treatment. |
| Focal injection of AU-011 and laser application with option for TURBT (4e) | EXPERIMENTAL | Participants with intermediate-risk NMIBC will receive multiple treatment cycles of focal AU-011 (400 µg per lesion) followed by laser activation, with the option for TURBT. Participants will be evaluated for safety and response to AU-011 for up to 12 months from initiation of treatment. Enrollment will occur in parallel with Cohort 4g, with randomized (1:1) assignment. |
| Focal injection of AU-011 and laser application with mandatory TURBT (4f) | EXPERIMENTAL | Participants with high-risk NMIBC will receive multiple treatment cycles of focal AU-011 (400 µg per lesion) followed by laser activation prior to mandatory TURBT. Participants will be evaluated for safety and response to AU-011 for up to 12 months from initiation of treatment. |
| Focal injection of AU-011 and laser application with optional TURBT (4g) | EXPERIMENTAL | Participants with intermediate-risk NMIBC will receive multiple treatment cycles of focal AU-011 (400 µg per lesion) followed by laser activation with the option of TURBT. Participants will be evaluated for safety and response to AU-011 for up to 12 months from initiation of treatment. Enrollment will occur in parallel with Cohort 4e, with randomized (1:1) assignment. |
| Focal injection of AU-011 and laser application with option for TURBT (4h) | EXPERIMENTAL | Participants with intermediate-risk NMIBC will receive multiple treatment cycles of focal AU-011 (800 ug per lesion) with laser treatment and option for TURBT. Participants will be evaluated for safety and response to AU-011 up to 12 months from initiation of treatment. This arm is optional and will be run at the discretion of the sponsor. |
| Focal injection of AU-011 and laser application with mandatory TURBT (4i) | EXPERIMENTAL | Participants with high-risk NMIBC will receive multiple treatment cycles of focal AU-011 (800 µg per lesion) before mandatory TURBT. Participants will be evaluated for safety and response to AU-011 up to 12 months from initiation of treatment. This arm is optional and will be run at the discretion of the sponsor. |
| Name | Type | Description |
|---|---|---|
| AU-011 | DRUG | AU-011 Via Suprachoroidal Administration with laser treatment |
| SCS Microinjector | DEVICE | Suprachoroidal Injection Device |
| Laser | DEVICE | Laser Administration |
| Suprachoroidal Microinjector | DEVICE | Suprachoroidal Injection Device |
| PDT Laser | DEVICE | Laser Administration |
| AU-011 in Combination with Medical Laser Adminstration | COMBINATION_PRODUCT | AU-011 Intratumorally and Intramurally |
| AU-011 in Combination with Medical Laser Administration | COMBINATION_PRODUCT | AU-011 Intratumorally |
Inclusion Criteria: * Have a clinical diagnosis of Metastases to the Choroid, from a histopathologically or cytologically confirmed tumor. * Have at least one Metastases to the Choroid in the study eye Exclusion Criteria: * Active ocular infection or disease. * Must not have evidence of a primary...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Incyte Corporation | INCY | 1 | PHASE2 | Retifanlimab |
| Pfizer Inc. | PFE | 1 | PHASE1 | Avelumab |
| Iovance Biotherapeutics Inc | IOVA | 2 | PHASE2 | Aldesleukin |
| Oncolytics Biotech Inc. | ONCY | 1 | PHASE1 | Pelareorep |
| TScan Therapeutics, Inc. | TCRX | 1 | PHASE1 | TSC-204-A0201, TSC-204-C0702, TSC-200-A0201, TSC-203-A0201, TSC-204-A0101 |
AU-011, also known as belzupacap sarotalocan, is an investigational small molecule being studied for eye cancer, non-muscle-invasive bladder cancer, and uveal melanoma. It is being developed by Aura Biosciences, Inc. (NASDAQ: AURA) and is currently in Phase 2 clinical development for these oncology indications.
AU-011 targets heparan sulfate proteoglycans, which are molecules found on the surface of cells. By binding to these proteoglycans, the drug is designed to deliver a therapeutic effect specifically to cancer cells. This mechanism is being investigated in clinical trials for eye cancer and bladder cancer.
AU-011 is being developed by Aura Biosciences, Inc., a biopharmaceutical company traded on NASDAQ under the ticker symbol AURA. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with various cancers, including uveal melanoma and non-muscle-invasive bladder cancer.
AU-011 is in Phase 2 clinical development. It is an investigational drug and has not been approved by the FDA. Clinical trials are ongoing to assess its use in eye cancer and non-muscle-invasive bladder cancer, with a completed Phase 2 trial in uveal melanoma.
AU-011 is being studied in several clinical trials. NCT06643884 is a Phase 2 trial for metastases to the choroid, NCT05483868 is a Phase 1 trial for non-muscle-invasive bladder cancer, and NCT04417530 is a completed Phase 2 trial for primary indeterminate lesions and small choroidal melanoma.
Yes, AU-011 is also known as belzupacap sarotalocan. Both names refer to the same investigational drug being developed by Aura Biosciences. In clinical trial records, the drug is often listed under its alternative name, belzupacap sarotalocan, while AU-011 is the code name used in research.