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Bel-sar

Phase 3

Choroidal Melanoma | Small molecule | Oncology |Aura Biosciences, Inc.|Last Updated: Mar 2, 2026

Success Probability
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Market & Valuation
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Trial Design
RandomizedDouble-BlindSHAM_CONTROLLEDDMC
Total Trials1
Total Enrollment100
FDA Designations
No designations recorded
Clinical trial landscape

Bel-sar · 1 trial · 4 indications

Phase 3 1
NCT06007690A Phase 3 Randomized, Masked, Controlled Trial to Evaluate Efficacy and Safety of Belzupacap Sarotalocan (AU-011) Treatment Compared to Sham Control in Subjects With Primary Indeterminate Lesions or Small Choroidal MelanomaChoroidal Melanoma
RECRUITING100 Analytics
PHASE3RECRUITING
A Phase 3 Randomized, Masked, Controlled Trial to Evaluate Efficacy and Safety of Belzupacap Sarotalocan (AU-011) Treatment Compared to Sham Control in Subjects With Primary Indeterminate Lesions or Small Choroidal Melanoma
Choroidal Melanoma
NCT06007690100
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Study Endpoints
Primary Endpoints
Time to reach tumor progression
65 weeks

Tumor Progression

Secondary Endpoints
Time to composite endpoint
65 weeks
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
High dose bel-sar treatment arm & laser applicationEXPERIMENTALHigh dose of bel-sar + laser application
Low dose bel-sar treatment arm & laser applicationEXPERIMENTALLow dose of bel-sar + laser application
Sham control arm & sham laserSHAM_COMPARATORSham injection + sham laser
Interventions
NameTypeDescription
Bel-sarDRUGBel-sar via suprachoroidal administration followed by laser application.
Suprachoroidal MicroinjectorDEVICESuprachoroidal injection device
Infrared LaserDEVICELaser application
Sham Infrared LaserDEVICESham laser application
Sham MicroinjectorDEVICESham injection device
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Eligibility Criteria
Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites71

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 ...

Countries:United StatesAustraliaAustriaBelgiumCanadaCzechiaFranceGermanyIsraelItalyNetherlandsNew ZealandSpainUnited Kingdom
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT06007690primaryCompletionDate: changed
LOWMay 24, 2026NCT06007690studyFirstPostDate: changed