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 (CoMpass)

Aura Biosciences

Status and phase: Enrolling; Phase 3

Conditions: Indeterminate Lesions; Ocular Melanoma; Choroidal Melanoma; Uveal Melanoma

Treatments: Device: Suprachoroidal Microinjector; Drug: Bel-sar; Device: Sham Microinjector; Device: Infrared Laser; Device: Sham Infrared Laser

Study type: Interventional

Funder types: Industry

Identifiers

NCT06007690

AU-011-301

Details and patient eligibility

About

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).

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 3 patient groups

High dose bel-sar treatment arm & laser application

Experimental group

Description:

High dose of bel-sar + laser application

Treatment:

Device: Infrared Laser

Drug: Bel-sar

Device: Suprachoroidal Microinjector

Low dose bel-sar treatment arm & laser application

Experimental group

Description:

Low dose of bel-sar + laser application

Treatment:

Device: Infrared Laser

Drug: Bel-sar

Device: Suprachoroidal Microinjector

Sham control arm & sham laser

Sham Comparator group

Description:

Sham injection + sham laser

Treatment:

Device: Sham Infrared Laser

Device: Sham Microinjector