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
Overview
- Phase
- Phase 1
- Intervention
- Laser Activation
- Conditions
- Uveal Melanoma
- Sponsor
- Aura Biosciences
- Enrollment
- 57
- Locations
- 13
- Primary Endpoint
- Number of Participants With Treatment-Emergent Adverse Events [Safety and Tolerability] of Light-activated AU-011
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
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.
Detailed 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Diagnosis of choroidal melanoma
Exclusion Criteria
- •Have known contraindications or sensitivities to the study drug
Arms & Interventions
Single High Dose Light-activated AU-011
High dose Light-activated AU-011 followed by a single laser light application
Intervention: Laser Activation
Single Low Dose Light-activated AU-011
Low dose Light-activated AU-011 followed by a single laser light application
Intervention: Light-activated AU-011
Single Low Dose Light-activated AU-011
Low dose Light-activated AU-011 followed by a single laser light application
Intervention: Laser Activation
Single Medium Dose Light-activated AU-011
Medium dose Light-activated AU-011 followed by a single laser light application
Intervention: Light-activated AU-011
Single Medium Dose Light-activated AU-011
Medium dose Light-activated AU-011 followed by a single laser light application
Intervention: Laser Activation
Single High Dose Light-activated AU-011
High dose Light-activated AU-011 followed by a single laser light application
Intervention: Light-activated AU-011
2 Repeat Medium Dose Light-activated AU-011
2 repeat medium doses of Light-activated AU-011 each followed by a single laser light application
Intervention: Light-activated AU-011
2 Repeat Medium Dose Light-activated AU-011
2 repeat medium doses of Light-activated AU-011 each followed by a single laser light application
Intervention: Laser Activation
3 Repeat Medium Dose Light-activated AU-011
3 repeat medium doses of Light-activated AU-011 followed by a single laser light application
Intervention: Light-activated AU-011
3 Repeat Medium Dose Light-activated AU-011
3 repeat medium doses of Light-activated AU-011 followed by a single laser light application
Intervention: Laser Activation
Single High Dose Light-activated AU-011 x 2 lasers
High dose Light-activated AU-011 followed by two laser light applications
Intervention: Light-activated AU-011
Single High Dose Light-activated AU-011 x 2 lasers
High dose Light-activated AU-011 followed by two laser light applications
Intervention: Laser Activation
3 Repeat High Dose Light-activated AU-011
3 repeat high doses of Light-activated AU-011 each followed by a single laser light application
Intervention: Light-activated AU-011
3 Repeat High Dose Light-activated AU-011
3 repeat high doses of Light-activated AU-011 each followed by a single laser light application
Intervention: Laser Activation
3 Repeat High Dose Light-activated AU-011 x 2 lasers
3 repeat high doses of Light-activated AU-011 each followed by two laser light applications
Intervention: Light-activated AU-011
3 Repeat High Dose Light-activated AU-011 x 2 lasers
3 repeat high doses of Light-activated AU-011 each followed by two laser light applications
Intervention: Laser Activation
Expansion 3 Repeat High Dose Light-activated AU-011 x 2 lasers
Expansion of 3 repeat high doses of Light-activated AU-011 each followed by two laser light applications (up to 12 additional subjects)
Intervention: Light-activated AU-011
Expansion 3 Repeat High Dose Light-activated AU-011 x 2 lasers
Expansion of 3 repeat high doses of Light-activated AU-011 each followed by two laser light applications (up to 12 additional subjects)
Intervention: Laser Activation
Observation until Documented Growth of Tumor
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
Intervention: Light-activated AU-011
Observation until Documented Growth of Tumor
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
Intervention: Laser Activation
2 Cycles of 3 Repeat High Dose Light-activated AU-011x2 lasers
2 cycles each of 3 repeat high doses of Light-activated AU-011 each followed by two laser light applications
Intervention: Light-activated AU-011
2 Cycles of 3 Repeat High Dose Light-activated AU-011x2 lasers
2 cycles each of 3 repeat high doses of Light-activated AU-011 each followed by two laser light applications
Intervention: Laser Activation
Exp: 2 Cycles 3 Repeat High Dose Light-activatedAU-011x2lasers
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
Intervention: Light-activated AU-011
Exp: 2 Cycles 3 Repeat High Dose Light-activatedAU-011x2lasers
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
Intervention: Laser Activation
Outcomes
Primary Outcomes
Number of Participants With Treatment-Emergent Adverse Events [Safety and Tolerability] of Light-activated AU-011
Time Frame: Informed consent through 1-2 years
Adverse events will be summarized by presenting the number and percentage of participants having any adverse event.
Secondary Outcomes
- Immunogenicity (Anti-AU-011 Antibody Analysis)(Screening to various time points through 24 months)
- Tumor Size (Thickness) Measured by Ultrasonography [Efficacy](Change from baseline following treatment and at each subsequent visit through Week 52)
- Tumor Size (Diameter) Measured by Fundus Photography [Efficacy](Change from baseline following treatment and at each subsequent visit through Week 52)
- Best Corrected Visual Acuity Measured by ETDRS Method [Efficacy] in Study Eye(Change from baseline following treatment and at each subsequent visit through Week 52)