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Light-activated AU-011 · 1 trial · 3 indications
Adverse events will be summarized by presenting the number and percentage of participants having any adverse event.
| Arm | Type | Description |
|---|---|---|
| Single Low Dose Light-activated AU-011 | EXPERIMENTAL | Low dose Light-activated AU-011 followed by a single laser light application |
| Single Medium Dose Light-activated AU-011 | EXPERIMENTAL | Medium dose Light-activated AU-011 followed by a single laser light application |
| Single High Dose Light-activated AU-011 | EXPERIMENTAL | High dose Light-activated AU-011 followed by a single laser light application |
| 2 Repeat Medium Dose Light-activated AU-011 | EXPERIMENTAL | 2 repeat medium doses of Light-activated AU-011 each followed by a single laser light application |
| 3 Repeat Medium Dose Light-activated AU-011 | EXPERIMENTAL | 3 repeat medium doses of Light-activated AU-011 followed by a single laser light application |
| Single High Dose Light-activated AU-011 x 2 lasers | EXPERIMENTAL | High dose Light-activated AU-011 followed by two laser light applications |
| 3 Repeat High Dose Light-activated AU-011 | EXPERIMENTAL | 3 repeat high doses of Light-activated AU-011 each followed by a single laser light application |
| 3 Repeat High Dose Light-activated AU-011 x 2 lasers | EXPERIMENTAL | 3 repeat high doses of Light-activated AU-011 each followed by two laser light applications |
| Expansion 3 Repeat High Dose Light-activated AU-011 x 2 lasers | EXPERIMENTAL | Expansion of 3 repeat high doses of Light-activated AU-011 each followed by two laser light applications (up to 12 additional subjects) |
| Observation until Documented Growth of Tumor | EXPERIMENTAL | Observation until documented growth of tumor and then treatment with 2 cycles each of 3 repeat high doses of Light-activated AU-011 each followed by two laser light applications |
| 2 Cycles of 3 Repeat High Dose Light-activated AU-011x2 lasers | EXPERIMENTAL | 2 cycles each of 3 repeat high doses of Light-activated AU-011 each followed by two laser light applications |
| Exp: 2 Cycles 3 Repeat High Dose Light-activatedAU-011x2lasers | EXPERIMENTAL | 2 cycles each of 3 repeat high doses of Light-activated AU-011 each followed by two laser light applications in subjects with evidence of documented tumor growth prior to study entry |
| Name | Type | Description |
|---|---|---|
| Light-activated AU-011 | DRUG | Study treatment |
| Laser Activation | DEVICE | Study treatment |
Inclusion Criteria: * Diagnosis of choroidal melanoma Exclusion Criteria: * Have known contraindications or sensitivities to the study drug
Light-activated AU-011 is an investigational small molecule being developed for the treatment of uveal melanoma, a type of eye cancer. It is designed to be activated by light to target and destroy cancer cells. The drug is currently in clinical development and has not been approved by regulatory authorities.
Light-activated AU-011 is being developed by Aura Biosciences, Inc., a biopharmaceutical company. The company's stock is traded under the ticker symbol AURA on the NASDAQ stock exchange. Aura Biosciences is focused on developing novel therapies for oncology indications.
Light-activated AU-011 is currently in Phase 1 clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory agencies such as the FDA. The drug is being studied for its safety and efficacy in patients with uveal melanoma.
Light-activated AU-011 has been studied in a Phase 1 clinical trial with the identifier NCT03052127. This trial, titled 'Study in Subjects With Small Primary Choroidal Melanoma,' was conducted in the United States and enrolled 57 participants. The trial has been completed.
Light-activated AU-011 is a small molecule that is activated by light. It is designed to be administered and then activated by a specific light source to target and destroy cancer cells. This mechanism is being studied for its potential to treat uveal melanoma.