Clinical Trials /

Phase 2 Trial to Evaluate Safety and Efficacy of AU-011 Via Suprachoroidal Administration in Subjects With Primary Indeterminate Lesions and Small Choroidal Melanoma

NCT04417530

Description:

The primary objective is to assess safety and efficacy of AU-011 via suprachoroidal injection to treat primary indeterminate lesions and small choroidal melanoma.

Related Conditions:
  • Choroid Melanoma
Recruiting Status:

Recruiting

Phase:

Phase 2

URL:

https://clinicaltrials.gov/show/NCT04417530

Trial Eligibility

Document

Title

  • Brief Title: Phase 2 Trial to Evaluate Safety and Efficacy of AU-011 Via Suprachoroidal Administration in Subjects With Primary Indeterminate Lesions and Small Choroidal Melanoma
  • Official Title: A Phase 2 Trial of AU-011 Via Suprachoroidal Administration With a Dose Escalation Phase (Open-label, Ascending Single and Repeat Dose) and a Randomized, Masked Dose Expansion Phase Designed to Evaluate the Safety and Efficacy of AU-011 in Subjects With Primary Indeterminate Lesions and Small Choroidal Melanoma

Clinical Trial IDs

  • ORG STUDY ID: AU-011-202
  • NCT ID: NCT04417530

Conditions

  • Uveal Melanoma
  • Ocular Melanoma
  • Choroidal Melanoma

Interventions

DrugSynonymsArms
AU-011Cohort 1 AU-011 & Laser

Purpose

The primary objective is to assess safety and efficacy of AU-011 via suprachoroidal injection to treat primary indeterminate lesions and small choroidal melanoma.

Detailed Description

      A Phase 2 Trial of AU-011 Via Suprachoroidal Administration With a Dose Escalation Phase
      (Open-label, Ascending Single and Repeat Dose) and a Randomized, Masked Dose Expansion Phase
      Designed to Evaluate the Safety and Efficacy of AU-011 in Subjects With Primary Indeterminate
      Lesions and Small Choroidal Melanoma.

Trial Arms

NameTypeDescriptionInterventions
Cohort 1 AU-011 & LaserExperimentalSingle dose of 20 µg of AU-011 + 1 laser application
  • AU-011
Cohort 2 AU-011 & LaserExperimentalSingle dose of 40 µg of AU-011 + 1 laser application
  • AU-011
Cohort 3 AU-011 & LaserExperimentalSingle dose of 40 µg of AU-011 + 2 laser applications
  • AU-011
Cohort 4 AU-011 & LaserExperimentalHighest tolerated dose of AU-011/laser applications from Cohorts 1 to 3 administered weekly for 2 treatments
  • AU-011
Cohort 5 AU-011 & LaserExperimentalHighest tolerated dose of AU-011/laser applications from Cohorts 1 to 3 administered weekly for 3 treatments. Up to 2 cycles of this regimen may be administered.
  • AU-011
Cohort 6 AU-011 & Laser or Sham TreatmentOtherSubjects will be randomized in a 1:1 ratio to receive either AU-011 (maximum tolerated dose regimen from Cohorts 1-5) or sham treatment.
  • AU-011

Eligibility Criteria

        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 naïve for IL/CM

        Exclusion Criteria:

          -  Have known contraindications or sensitivities to the study drug or laser

          -  Active ocular disease
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Tumor Thickness Growth Rates
Time Frame:52 weeks
Safety Issue:
Description:Tumor Thickness growth rates over 52 weeks

Details

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

Trial Keywords

  • Uveal Melanoma
  • Eye Cancer
  • Ocular Melanoma
  • Choroidal Melanoma

Last Updated

March 17, 2021