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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

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

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06007690
Acronym
CoMpass
Enrollment
100
Registered
2023-08-23
Start date
2023-12-06
Completion date
2028-08-15
Last updated
2026-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Choroidal Melanoma, Indeterminate Lesions, Uveal Melanoma, Ocular Melanoma

Keywords

Uveal Melanoma, Eye Cancer, Ocular Melanoma, Choroidal Melanoma

Brief summary

The primary objective is to determine the safety and efficacy of belzupacap sarotalocan (bel-sar) compared to sham control in patients with primary indeterminate lesions (IL) or small choroidal melanoma (CM).

Detailed description

This is a randomized, sham-controlled, subject-, assessor-, and Sponsor- masked trial to establish the safety and efficacy of bel-sar treatment via suprachoroidal (SC) administration in subjects with primary IL/CM. Bel-sar treatment incorporates administration of bel-sar drug product using a suprachoroidal space (SCS) microinjector and activation of bel-sar by a laser photoactivation device.

Interventions

DRUGBel-sar

Bel-sar via suprachoroidal administration followed by laser application.

DEVICESuprachoroidal Microinjector

Suprachoroidal injection device

DEVICEInfrared Laser

Laser application

DEVICESham Infrared Laser

Sham laser application

DEVICESham Microinjector

Sham injection device

Sponsors

Aura Biosciences
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Masking description

Subject, Assessor, and Sponsor masked trial.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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 or sensitivities to the study drug or laser * Active ocular infection or disease

Design outcomes

Primary

MeasureTime frameDescription
Time to reach tumor progression65 weeksTumor Progression

Secondary

MeasureTime frameDescription
Time to composite endpoint65 weeksTumor progression or visual acuity failure

Countries

Australia, Austria, Belgium, Canada, Czechia, France, Germany, Israel, Italy, Netherlands, New Zealand, Spain, United Kingdom, United States

Contacts

CONTACTMedical Monitor
clinical@aurabiosciences.com617-500-8864
STUDY_DIRECTORMedical Monitor

Aura Biosciences

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 3, 2026