NCT03052127

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
57

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Feb 2017

Longer than P75 for phase_1

Geographic Reach
1 country

13 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 6, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 14, 2017

Completed
13 days until next milestone

Study Start

First participant enrolled

February 27, 2017

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 26, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 26, 2021

Completed
3 years until next milestone

Results Posted

Study results publicly available

February 1, 2024

Completed
Last Updated

February 1, 2024

Status Verified

January 1, 2024

Enrollment Period

3.9 years

First QC Date

February 6, 2017

Results QC Date

December 19, 2023

Last Update Submit

January 30, 2024

Conditions

Uveal MelanomaOcular MelanomaChoroidal Melanoma

Keywords

Uveal melanomaEye cancerOcular melanomaChoroidal melanoma

Outcome Measures

Primary Outcomes (1)

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

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

    Informed consent through 1-2 years

Secondary Outcomes (4)

  • 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

Study Arms (12)

Single Low Dose Light-activated AU-011

EXPERIMENTAL

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

Drug: Light-activated AU-011Device: Laser Activation

Single Medium Dose Light-activated AU-011

EXPERIMENTAL

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

Drug: Light-activated AU-011Device: Laser Activation

Single High Dose Light-activated AU-011

EXPERIMENTAL

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

Drug: Light-activated AU-011Device: Laser Activation

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

Drug: Light-activated AU-011Device: Laser Activation

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

Drug: Light-activated AU-011Device: Laser Activation

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

EXPERIMENTAL

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

Drug: Light-activated AU-011Device: Laser Activation

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

Drug: Light-activated AU-011Device: Laser Activation

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

Drug: Light-activated AU-011Device: Laser Activation

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)

Drug: Light-activated AU-011Device: Laser Activation

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

Drug: Light-activated AU-011Device: Laser Activation

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

Drug: Light-activated AU-011Device: Laser Activation

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

Drug: Light-activated AU-011Device: Laser Activation

Interventions

Light-activated AU-011DRUG

Study treatment

2 Cycles of 3 Repeat High Dose Light-activated AU-011x2 lasers2 Repeat Medium Dose Light-activated AU-0113 Repeat High Dose Light-activated AU-0113 Repeat High Dose Light-activated AU-011 x 2 lasers3 Repeat Medium Dose Light-activated AU-011Exp: 2 Cycles 3 Repeat High Dose Light-activatedAU-011x2lasersExpansion 3 Repeat High Dose Light-activated AU-011 x 2 lasersObservation until Documented Growth of TumorSingle High Dose Light-activated AU-011Single High Dose Light-activated AU-011 x 2 lasersSingle Low Dose Light-activated AU-011Single Medium Dose Light-activated AU-011
Laser ActivationDEVICE

Study treatment

Also known as: PDT Laser
2 Cycles of 3 Repeat High Dose Light-activated AU-011x2 lasers2 Repeat Medium Dose Light-activated AU-0113 Repeat High Dose Light-activated AU-0113 Repeat High Dose Light-activated AU-011 x 2 lasers3 Repeat Medium Dose Light-activated AU-011Exp: 2 Cycles 3 Repeat High Dose Light-activatedAU-011x2lasersExpansion 3 Repeat High Dose Light-activated AU-011 x 2 lasersObservation until Documented Growth of TumorSingle High Dose Light-activated AU-011Single High Dose Light-activated AU-011 x 2 lasersSingle Low Dose Light-activated AU-011Single Medium Dose Light-activated AU-011

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of choroidal melanoma

You may not qualify if:

  • Have known contraindications or sensitivities to the study drug

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

Retina Associates SW, P.C.

Tucson, Arizona, 85710, United States

Location

UCLA Jules Stein Eye Institute

Los Angeles, California, 90095, United States

Location

Byers Eye Institute at Stanford University

Palo Alto, California, 94303, United States

Location

Retina Consultants of Sacramento

Sacramento, California, 95819, United States

Location

Colorado Retina Associates

Denver, Colorado, 80210, United States

Location

Massachusetts Eye and Ear Infirmary

Boston, Massachusetts, 02114, United States

Location

W. K. Kellogg Eye Center, University of Michigan

Ann Arbor, Michigan, 48105, United States

Location

Associated Retinal Consultants, PC

Royal Oak, Michigan, 48073, United States

Location

Retina Center

Minneapolis, Minnesota, 55404, United States

Location

Columbia University Medical Center

New York, New York, 10027, United States

Location

Wills Eye Hospital

Philadelphia, Pennsylvania, 19107, United States

Location

Retina Consultants of Carolina, PA

Greenville, South Carolina, 29605, United States

Location

Retina Consultants of Houston

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Uveal MelanomaEye Neoplasms

Condition Hierarchy (Ancestors)

MelanomaNeuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve TissueNevi and MelanomasUveal NeoplasmsNeoplasms by SiteEye DiseasesUveal Diseases

Results Point of Contact

Title
Uma Chandrasekaran, Director, Clinical Development Scientist
Organization
Aura Biosciences
UChandrasekaran@aurabiosciences.com
706-294-3454

Study Officials

  • Abhijit Narvekar, MBBS

    Aura Biosciences

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 6, 2017

First Posted

February 14, 2017

Study Start

February 27, 2017

Primary Completion

January 26, 2021

Study Completion

January 26, 2021

Last Updated

February 1, 2024

Results First Posted

February 1, 2024

Record last verified: 2024-01

Locations

US(13)