Recent Updates
Recently added Catalysts

Light-activated AU-011

Phase 1

Uveal Melanoma | Small molecule | Oncology |Aura Biosciences, Inc.|Last Updated: Feb 1, 2024

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
CONTROLLED
Total Trials1
Total Enrollment57
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03052127Study in Subjects With Small Primary Choroidal MelanomaPHASE1 COMPLETED 57 — — Feb 27, 2017Jan 26, 2021Feb 1, 202413 United States
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
Number of Participants With Treatment-Emergent Adverse Events [Safety and Tolerability] of Light-activated AU-011
Informed consent through 1-2 years

Adverse events will be summarized by presenting the number and percentage of participants having any adverse event.

Secondary Endpoints
Immunogenicity (Anti-AU-011 Antibody Analysis)
Screening to various time points through 24 months
Tumor Size (Thickness) Measured by Ultrasonography [Efficacy]
Change from baseline following treatment and at each subsequent visit through Week 52
Tumor Size (Diameter) Measured by Fundus Photography [Efficacy]
Change from baseline following treatment and at each subsequent visit through Week 52
Unlock Study Endpoints
Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Single Low Dose Light-activated AU-011EXPERIMENTALLow dose Light-activated AU-011 followed by a single laser light application
Single Medium Dose Light-activated AU-011EXPERIMENTALMedium dose Light-activated AU-011 followed by a single laser light application
Single High Dose Light-activated AU-011EXPERIMENTALHigh dose Light-activated AU-011 followed by a single laser light application
2 Repeat Medium Dose Light-activated AU-011EXPERIMENTAL2 repeat medium doses of Light-activated AU-011 each followed by a single laser light application
3 Repeat Medium Dose Light-activated AU-011EXPERIMENTAL3 repeat medium doses of Light-activated AU-011 followed by a single laser light application
Single High Dose Light-activated AU-011 x 2 lasersEXPERIMENTALHigh dose Light-activated AU-011 followed by two laser light applications
3 Repeat High Dose Light-activated AU-011EXPERIMENTAL3 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 lasersEXPERIMENTAL3 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 lasersEXPERIMENTALExpansion 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 TumorEXPERIMENTALObservation 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 lasersEXPERIMENTAL2 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-011x2lasersEXPERIMENTAL2 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
Interventions
NameTypeDescription
Light-activated AU-011DRUGStudy treatment
Laser ActivationDEVICEStudy treatment
Unlock Study Design Details
Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites13

Inclusion Criteria: * Diagnosis of choroidal melanoma Exclusion Criteria: * Have known contraindications or sensitivities to the study drug

Countries:United States
Unlock Eligibility Criteria