Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Eye Diseases

Rare Diseases

Melanoma

Eye Neoplasms

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Skin Neoplasms

Skin Diseases

Ocular Melanoma

Intraocular Melanoma

Neuroendocrine Tumor

Neuroepithelioma

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

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

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

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

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

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

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

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

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

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

Light-activated AU-011

Laser Activation

Abhijit Narvekar, MBBS

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.

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.

Study in Subjects With Small Primary Choroidal Melanoma

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

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

Percentage of Participants with Anti-AU-011 Antibodies (Anti-Drug Antibody, ADA)

Change from Baseline in maximum tumor thickness (in millimeters) assessed at each study visit using B-scan ultrasound.

Change from Baseline in tumor Largest Basal Diameter (LBD) assessed at each study visit based on fundus photos (millimeters) in participants treated with AU-011.

Change from Baseline in Best Corrected Visual Acuity using ETDRS letters in Study Eye at each study visit.

Aura Biosciences

Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011.

Adverse events (AEs) were defined as events that were new or worsened during the treatment period.

AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).

Low dose (20 µg) Light-activated AU-011 followed by a single laser light application

Light-activated AU-011: Study treatment

Laser Activation: Study treatment

Cohort 1 (Light-activated AU-011)

Medium dose (40 µg) Light-activated AU-011 followed by a single laser light application

Light-activated AU-011: Study treatment

Laser Activation: Study treatment

Cohort 2 (Single Medium Dose Light-activated AU-011)

High dose (80 µg) Light-activated AU-011 followed by a single laser light application

Light-activated AU-011: Study treatment

Laser Activation: Study treatment

Cohort 3 (Single High Dose Light-activated AU-011)

2 repeat medium doses (40 µg) of Light-activated AU-011 each followed by a single laser light application

Light-activated AU-011: Study treatment

Laser Activation: Study treatment

Cohort 4 (2 Repeat Medium Dose Light-activated AU-011)

3 repeat medium doses (40 µg) of Light-activated AU-011 followed by a single laser light application

Light-activated AU-011: Study treatment

Laser Activation: Study treatment

Cohort 5 (3 Repeat Medium Dose Light-activated AU-011)

High dose (80 µg) Light-activated AU-011 followed by two laser light applications

Light-activated AU-011: Study treatment

Laser Activation: Study treatment

Cohort 6 (Single High Dose Light-activated AU-011 x 2 Lasers)

3 repeat high doses (80 µg) of Light-activated AU-011 each followed by a single laser light application

Light-activated AU-011: Study treatment

Laser Activation: Study treatment

Cohort 7 (3 Repeat High Dose Light-activated AU-011)

3 repeat high doses (80 µg) of Light-activated AU-011 each followed by two laser light applications

Light-activated AU-011: Study treatment

Laser Activation: Study treatment

Cohort 8 (3 Repeat High Dose Light-activated AU-011 x 2 Lasers)

Expansion of 3 repeat high doses (80 µg) of Light-activated AU-011 each followed by two laser light applications once for 3 weeks with potential for retreatment

Light-activated AU-011: Study treatment

Laser Activation: Study treatment

Cohort 9 (Expansion 3 Repeat High Dose Light-activated AU-011 x 2 Lasers)

Expansion - Observation until documented growth of tumor and then treatment with 2 cycles each of 3 repeat high doses (80 µg) of Light-activated AU-011 each followed by two laser light applications

Light-activated AU-011: Study treatment

Laser Activation: Study treatment

Cohort 10 (Observation Until Documented Growth of Tumor)

Expansion - 2 cycles each of 3 repeat high doses (80 µg) of Light-activated AU-011 each followed by two laser light applications

Light-activated AU-011: Study treatment

Laser Activation: Study treatment

Cohort 11 (2 Cycles of 3 Repeat High Dose Light-activated AU-011x2 Lasers)

Expansion: 2 cycles each of 3 repeat high doses (80 µg) of Light-activated AU-011 each followed by two laser light applications in subjects with evidence of documented tumor growth prior to study entry

Light-activated AU-011: Study treatment

Laser Activation: Study treatment

Cohort 12 (2 Cycles 3 Repeat High Dose Light-activatedAU-011x2lasers)

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Tumor lesion thickness

Tumor largest basal diameter

Distance from fovea

Distance from nerve edge

Tumor thickness assessed using B-scan/ultrasound (reported by independent reading center). Tumor largest basal diameter, distance from fovea, distance from nerve edge - assessed by fundus photography (reported by independent reading center).

Baseline Tumor Characteristics

Documented Growth

Subretinal fluid

Orange pigmentation

Vision loss

Flashes or floaters

Risk factors for diagnosis and growth/progression of primary choroidal melanoma include documented growth, subretinal fluid, presence of orange pigment, decreased vision caused by the tumor, and visual symptoms such as flashes/floaters etc.

Baseline Risk factors

Study Eye

Fellow Eye

Visual Acuity assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) method in the intention-to treat (ITT) population

Visual Acuity Scores (ETDRS Letters) in Both Eyes

The intention-to-treat (ITT) population defined as all enrolled participants, whether or not they received an administration of AU-011 was used for baseline characteristics.

Uma Chandrasekaran, Director, Clinical Development Scientist

All participants who received at least 1 dose of AU-011 were used for safety analyses.

Adverse events were defined as events that were new or worsened during the treatment period.

AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria \[v4.03\]).

Number of Participants With Treatment-Emergent Adverse Events [Safety and Tolerability] of Light-activated AU-011

Subjects who had at least one post-AU-011 dose result were defined in this study as being evaluable for assessment of treatment-induced antibodies to AU-011.

Negative ADA refers to all negative values at baseline and post-treatment Treatment-induced ADA refers to negative value at baseline and at least 1 positive result post-treatment Treatment-unaffected ADA refers to positive value at baseline and at least 1 reported result post-treatment

Immunogenicity (Anti-AU-011 Antibody Analysis)

Baseline

Day 2 (Visit 3)

Day 8 (Visit 4)

Day 15 (Visit 6)

Day 29 (Visit 8)

Week 8 (Visit 10)

Week 12 (Visit 11)

Week 26 (Visit 12)

Week 39 (Visit 13)

Week 52 (Visit 14)

The intention-to-treat (ITT) population was defined as all enrolled participants, whether or not they received an administration of AU-011.

Note: The Baseline tumor thickness (TT) values reported for Cohort 10 in the table below (i.e., 2.583 (0.542)) includes only 2 participants who received AU-011. However, the TT values reported in the Baseline Characteristics table (i.e., 2.6 (0.38) includes 3 participants enrolled in the study (ITT population).

Tumor Size (Thickness) Measured by Ultrasonography [Efficacy]

Day 9 (Visit 5)

Day 16 (Visit 7)

Week 6 (Visit 9)

The intention-to-treat (ITT) population was defined as all enrolled participants, whether or not they received an administration of AU-011.

Note: The Baseline tumor Largest Basal Diameter (LBD) values reported for Cohort 10 in the table below (i.e., 10.088 (2.825)) includes only 2 participants who received AU-011. However, the LBD values reported in the Baseline Characteristics table (i.e., 9.7 (2.1) includes 3 participants enrolled in Cohort 10 (ITT population).

Tumor Size (Diameter) Measured by Fundus Photography [Efficacy]

Cohort 11 (2 Cycles of 3 Repeat High Dose Light-activated AU-011 x 2 Lasers)

Cohort 12 (2 Cycles 3 Repeat High Dose Light-activatedAU-011 x 2 Lasers)

The intention-to-treat (ITT) population was defined as all enrolled participants, whether or not they received an administration of AU-011.

Spots Global Cancer Trial Database for Study in Subjects With Small Primary Choroidal Melanoma

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

Useful links and downloads for this trial