Trial | NCT03052127  Report issue

Title

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

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    57
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 Started
Feb 27
2017
Primary Completion
Jan 26
2021
Study Completion
Jan 26
2021
Last Update
Jan 14
2022

Drug Light-activated AU-011

Study treatment

Device Laser Activation

Study treatment

  • Other names: PDT Laser

Single Low Dose Light-activated AU-011 Experimental

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

Single Medium Dose Light-activated AU-011 Experimental

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

Single High Dose Light-activated AU-011 Experimental

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

2 Repeat Medium Dose Light-activated AU-011 Experimental

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

3 Repeat Medium Dose Light-activated AU-011 Experimental

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

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

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

3 Repeat High Dose Light-activated AU-011 Experimental

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

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

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

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

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 Experimental

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

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

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

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

Criteria 

Inclusion Criteria:

Diagnosis of choroidal melanoma

Exclusion Criteria:

Have known contraindications or sensitivities to the study drug
No Results Posted