Study in Subjects With Small Primary Choroidal Melanoma

Aura Biosciences

Status and phase: Completed; Phase 2; Phase 1

Conditions: Ocular Melanoma; Choroidal Melanoma; Uveal Melanoma

Treatments: Device: Laser Activation; Drug: Light-activated AU-011

Study type: Interventional

Funder types: Industry

Identifiers

NCT03052127

AU-011-101

Details and patient eligibility

About

The primary objective is to assess the safety, immunogenicity and efficacy of one of three dose levels and repeat dose regimens of Light-activated AU-011 and one or two laser applications for the treatment of subjects with primary choroidal melanoma.

Full description

This is a phase 1B/2 open-label, ascending single and repeat dose clinical trial designed to evaluate the safety and efficacy of Light-activated AU-011 for the treatment of subjects with small primary choroidal melanoma.

Throughout the study, subjects will be monitored through medical and ophthalmic assessments. Subjects will be followed for a total of 2 years.

Enrollment: 57 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of choroidal melanoma

Exclusion criteria

• Have known contraindications or sensitivities to the study drug

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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57 participants in 12 patient groups

Single Low Dose Light-activated AU-011

Experimental group

Description:

Low dose Light-activated AU-011 followed by a single laser light application

Treatment:

Drug: Light-activated AU-011

Device: Laser Activation

Single Medium Dose Light-activated AU-011

Experimental group

Description:

Medium dose Light-activated AU-011 followed by a single laser light application

Treatment:

Drug: Light-activated AU-011

Device: Laser Activation

Single High Dose Light-activated AU-011

Experimental group

Description:

High dose Light-activated AU-011 followed by a single laser light application

Treatment:

Drug: Light-activated AU-011

Device: Laser Activation

2 Repeat Medium Dose Light-activated AU-011

Experimental group

Description:

2 repeat medium doses of Light-activated AU-011 each followed by a single laser light application

Treatment:

Drug: Light-activated AU-011

Device: Laser Activation

3 Repeat Medium Dose Light-activated AU-011

Experimental group

Description:

3 repeat medium doses of Light-activated AU-011 followed by a single laser light application

Treatment:

Drug: Light-activated AU-011

Device: Laser Activation

Single High Dose Light-activated AU-011 x 2 lasers

Experimental group

Description:

High dose Light-activated AU-011 followed by two laser light applications

Treatment:

Drug: Light-activated AU-011

Device: Laser Activation

3 Repeat High Dose Light-activated AU-011

Experimental group

Description:

3 repeat high doses of Light-activated AU-011 each followed by a single laser light application

Treatment:

Drug: Light-activated AU-011

Device: Laser Activation

3 Repeat High Dose Light-activated AU-011 x 2 lasers

Experimental group

Description:

3 repeat high doses of Light-activated AU-011 each followed by two laser light applications

Treatment:

Drug: Light-activated AU-011

Device: Laser Activation

Expansion 3 Repeat High Dose Light-activated AU-011 x 2 lasers

Experimental group

Description:

Expansion of 3 repeat high doses of Light-activated AU-011 each followed by two laser light applications (up to 12 additional subjects)

Treatment:

Drug: Light-activated AU-011

Device: Laser Activation

Observation until Documented Growth of Tumor

Experimental group

Description:

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

Treatment:

Drug: Light-activated AU-011

Device: Laser Activation

2 Cycles of 3 Repeat High Dose Light-activated AU-011x2 lasers

Experimental group

Description:

2 cycles each of 3 repeat high doses of Light-activated AU-011 each followed by two laser light applications

Treatment:

Drug: Light-activated AU-011

Device: Laser Activation

Exp: 2 Cycles 3 Repeat High Dose Light-activatedAU-011x2lasers

Experimental group

Description:

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

Treatment:

Drug: Light-activated AU-011

Device: Laser Activation