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Also known as AU-011, belzupacap sarotalocan
Bel-sar · 4 trials · 12 indications
Tumor Progression
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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 |
|---|---|---|
| High dose bel-sar treatment arm & laser application | EXPERIMENTAL | High dose of bel-sar + laser application |
| Low dose bel-sar treatment arm & laser application | EXPERIMENTAL | Low dose of bel-sar + laser application |
| Sham control arm & sham laser | SHAM_COMPARATOR | Sham injection + sham laser |
| 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 |
|---|---|---|
| Bel-sar | DRUG | Bel-sar via suprachoroidal administration followed by laser application. |
| Suprachoroidal Microinjector | DEVICE | Suprachoroidal injection device |
| Infrared Laser | DEVICE | Laser application |
| Sham Infrared Laser | DEVICE | Sham laser application |
| Sham Microinjector | DEVICE | Sham injection device |
| AU-011 | DRUG | AU-011 Via Suprachoroidal Administration with laser treatment |
| SCS Microinjector | DEVICE | Suprachoroidal Injection Device |
| Laser | DEVICE | Laser Administration |
| 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: * Clinical diagnosis of primary indeterminate lesion or small choroidal melanoma (IL/CM) * Have no evidence of metastatic disease confirmed by imaging * Be treatment naive for IL/CM (subjects who received PDT may be eligible) Exclusion Criteria: * Have known contraindications ...
Bel-sar, also known as belzupacap sarotalocan or AU-011, is an investigational small molecule being developed for the treatment of choroidal melanoma, including primary indeterminate lesions and small choroidal melanoma. It is also being studied for related conditions such as uveal melanoma and ocular melanoma.
Bel-sar is a small molecule, but its specific molecular target has not been disclosed. The drug is being studied for its efficacy and safety in treating choroidal melanoma, a type of eye cancer, though the exact mechanism of action is not publicly detailed.
Bel-sar is being developed by Aura Biosciences, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol AURA. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with choroidal melanoma.
Bel-sar is currently in Phase 3 clinical development. It is being evaluated in a randomized, double-blind, sham-controlled trial for the treatment of primary indeterminate lesions or small choroidal melanoma. The drug is investigational and has not yet been approved by regulatory authorities.
Bel-sar is being studied in a Phase 3 clinical trial with the identifier NCT06007690. This trial is a randomized, masked, controlled study comparing Bel-sar treatment to sham control in subjects with primary indeterminate lesions or small choroidal melanoma. The trial is active but not recruiting, with an enrollment of 108 participants.
Yes, Bel-sar is also known as belzupacap sarotalocan and AU-011. These names refer to the same investigational drug being developed by Aura Biosciences for the treatment of choroidal melanoma. The drug is currently in Phase 3 clinical trials.