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...
AU-011, also known as belzupacap sarotalocan, is an investigational small molecule being developed for oncology indications, including uveal melanoma, eye cancer, and non-muscle-invasive bladder cancer. It is being studied for the treatment of primary indeterminate lesions and small choroidal melanoma, as well as metastases to the choroid.
AU-011 is a small molecule, but its specific molecular target has not been disclosed in the available information. The drug is being evaluated for its anti-cancer activity in ocular and bladder cancers, though the exact mechanism of action is not specified.
AU-011 is being developed by Aura Biosciences, Inc., a biopharmaceutical company traded on the stock market under the ticker symbol AURA. The company is conducting clinical trials to evaluate the drug's safety and efficacy in multiple oncology indications.
AU-011 is in Phase 2 clinical development for uveal melanoma and eye cancer, and in Phase 1 for non-muscle-invasive bladder cancer. It is an investigational drug and has not been approved by regulatory authorities. The Phase 2 trial for choroidal melanoma has been completed.
AU-011 is being studied in three clinical trials. NCT04417530 is a completed Phase 2 trial in uveal melanoma with 22 participants. NCT05483868 is an active Phase 1 trial in non-muscle-invasive bladder cancer with 55 participants. NCT06643884 is a recruiting Phase 2 trial in eye cancer with 24 participants.
Yes, AU-011 is also known as belzupacap sarotalocan. The drug is referred to by both names in clinical trial records and scientific literature, with belzupacap sarotalocan being the nonproprietary name.