Clinical Trials /

Study in Subjects With Small Primary Choroidal Melanoma

NCT03052127

Description:

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.

Related Conditions:
  • Choroid Melanoma
Recruiting Status:

Active, not recruiting

Phase:

Phase 1/Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Study in Subjects With Small Primary Choroidal Melanoma
  • Official Title: 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

Clinical Trial IDs

  • ORG STUDY ID: AU-011-101
  • NCT ID: NCT03052127

Conditions

  • Uveal Melanoma
  • Ocular Melanoma
  • Choroidal Melanoma

Interventions

DrugSynonymsArms
Light-activated AU-011Single Low Dose Light-activated AU-011

Purpose

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.
    

Trial Arms

NameTypeDescriptionInterventions
Single Low Dose Light-activated AU-011ExperimentalLow dose Light-activated AU-011 followed by a single laser light application
  • Light-activated AU-011
Single Medium Dose Light-activated AU-011ExperimentalMedium dose Light-activated AU-011 followed by a single laser light application
  • Light-activated AU-011
Single High Dose Light-activated AU-011ExperimentalHigh dose Light-activated AU-011 followed by a single laser light application
  • Light-activated AU-011
2 Repeat Medium Dose Light-activated AU-011Experimental2 repeat medium doses of Light-activated AU-011 each followed by a single laser light application
  • Light-activated AU-011
3 Repeat Medium Dose Light-activated AU-011Experimental3 repeat medium doses of Light-activated AU-011 followed by a single laser light application
  • Light-activated AU-011
Single High Dose Light-activated AU-011 x 2 lasersExperimentalHigh dose Light-activated AU-011 followed by two laser light applications
  • Light-activated AU-011
3 Repeat High Dose Light-activated AU-011Experimental3 repeat high doses of Light-activated AU-011 each followed by a single laser light application
  • Light-activated AU-011
3 Repeat High Dose Light-activated AU-011 x 2 lasersExperimental3 repeat high doses of Light-activated AU-011 each followed by two laser light applications
  • Light-activated AU-011
Expansion 3 Repeat High Dose Light-activated AU-011 x 2 lasersExperimentalExpansion of 3 repeat high doses of Light-activated AU-011 each followed by two laser light applications (up to 12 additional subjects)
  • Light-activated AU-011
Observation until Documented Growth of TumorExperimentalObservation 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
  • Light-activated AU-011
2 Cycles of 3 Repeat High Dose Light-activated AU-011x2 lasersExperimental2 cycles each of 3 repeat high doses of Light-activated AU-011 each followed by two laser light applications
  • Light-activated AU-011
Exp: 2 Cycles 3 Repeat High Dose Light-activatedAU-011x2lasersExperimental2 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

Eligibility Criteria

        Inclusion Criteria:

          -  Diagnosis of choroidal melanoma

        Exclusion Criteria:

          -  Have known contraindications or sensitivities to the study drug
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] of Light-activated AU-011
Time Frame:Informed consent through 2 years
Safety Issue:
Description:Adverse events will be summarized by presenting the number and percentage of patients having any adverse event.

Secondary Outcome Measures

Measure:Immunogenicity
Time Frame:Screening to various time points through Week 52
Safety Issue:
Description:Anti-Drug Antibody analysis
Measure:Tumor size (thickness) measured by ultrasonography [Efficacy]
Time Frame:Change from baseline at 3 months following treatment and at each subsequent visit through study completion (2 years)
Safety Issue:
Description:Tumor size (thickness) measured by ultrasonography (millimeters)
Measure:Tumor size (diameter) measured by fundus photography [Efficacy]
Time Frame:Change from baseline at 3 months following treatment and at each subsequent visit through study completion (2 years)
Safety Issue:
Description:Tumor size (diameter) measured by fundus photography (millimeters)
Measure:Best Corrected Visual Acuity measured by ETDRS Method [Efficacy]
Time Frame:Change from baseline at 3 months following treatment and at each subsequent visit through study completion (2 years)
Safety Issue:
Description:Changes in ETDRS best corrected visual acuity (BCVA)

Details

Phase:Phase 1/Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Aura Biosciences

Trial Keywords

  • Uveal melanoma
  • Eye cancer
  • Ocular melanoma
  • Choroidal melanoma

Last Updated

September 6, 2019