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Phase 2 Trial to Evaluate Belzupacap Sarotalocan (AU-011) Via Suprachoroidal Administration in Subjects With Primary Indeterminate Lesions and Small Choroidal Melanoma

Primary Purpose

Uveal Melanoma, Ocular Melanoma, Choroidal Melanoma

Status
Active
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
AU-011
Suprachoroidal Microinjector
PDT Laser
Sponsored by
Aura Biosciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Uveal Melanoma focused on measuring Uveal Melanoma, Eye Cancer, Ocular Melanoma, Choroidal Melanoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Retina Associates SW, P.C.
  • UCLA Jules Stein Eye Institute
  • Byers Eye Institute at Stanford University
  • UCHealth Eye Center
  • Retina Associates of Florida
  • Emory Eye Center
  • University of Illinois At Chicago Illinois Eye and Ear Infirmary
  • Midwest Eye Institute
  • University of Iowa Department of Ophthalmology and Visual Sciences
  • Massachusetts Eye and Ear Infirmary
  • W. K. Kellogg Eye Center, University of Michigan
  • Associated Retinal Consultants, PC
  • Retina Center
  • Columbia University Medical Center
  • Dean McGee Eye Institute
  • Oregon Health & Science University Casey Eye Institute
  • Wills Eye Hospital
  • Retina Consultants of Carolina, PA
  • St. Thomas Health / Tennessee Retina, PC
  • Texas Retina Associates
  • Retina Consultants of Houston
  • University of Wisconsin Dept of Ophthalmology & Visual Sciences

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Cohort 1 AU-011 & Laser

Cohort 2 AU-011 & Laser

Cohort 3 AU-011 & Laser

Cohort 4 AU-011 & Laser

Cohort 5 AU-011 & Laser

Cohort 6 AU-011 & Laser

Arm Description

Low dose of AU-011 + 1 laser application

Medium dose of AU-011 + 1 laser application

Medium dose of AU-011 + 2 laser applications

Highest tolerated dose of AU-011/laser applications from Cohorts 1 to 3 administered weekly for 2 treatments

AU-011/laser applications from Cohorts 1 to 3 administered weekly for 3 treatments. Up to 2 cycles of this regimen may be administered and subjects have the option of receiving a third cycle of treatment.

High dose of AU-011/laser applications administered weekly for 3 treatments and up to 3 cycles of treatment.

Outcomes

Primary Outcome Measures

Treatment related AEs and treatment related serious adverse events (SAEs).
Adverse Events

Secondary Outcome Measures

Within-subject difference of historical tumor thickness growth rate and post-treatment growth rate over 52 weeks.
Tumor Thickness Growth Rate
Time to reach tumor progression
Tumor progression

Full Information

First Posted
June 2, 2020
Last Updated
June 21, 2023
Sponsor
Aura Biosciences
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1. Study Identification

Unique Protocol Identification Number
NCT04417530
Brief Title
Phase 2 Trial to Evaluate Belzupacap Sarotalocan (AU-011) Via Suprachoroidal Administration in Subjects With Primary Indeterminate Lesions and Small Choroidal Melanoma
Official Title
A Phase 2 Open-label, Ascending Single and Repeat Dose Escalation Trial of Belzupacap Sarotalocan (AU-011) Via Suprachoroidal Administration in Subjects With Primary Indeterminate Lesions and Small Choroidal Melanoma
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 5, 2020 (Actual)
Primary Completion Date
May 1, 2024 (Anticipated)
Study Completion Date
May 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Aura Biosciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The primary objective is to determine the safety, tolerability, and preliminary efficacy of belzupacap sarotalocan for the treatment of primary indeterminate lesions and small choroidal melanoma (IL/CM).
Detailed Description
This is an open-label, ascending single and repeat dose escalation trial designed to evaluate the safety, tolerability, and preliminary efficacy of up to 4 dose levels and repeat dose regimens of belzupacap sarotalocan via suprachoroidal administration with 1 or 2 laser applications per treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uveal Melanoma, Ocular Melanoma, Choroidal Melanoma
Keywords
Uveal Melanoma, Eye Cancer, Ocular Melanoma, Choroidal Melanoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cohort 1 AU-011 & Laser
Arm Type
Experimental
Arm Description
Low dose of AU-011 + 1 laser application
Arm Title
Cohort 2 AU-011 & Laser
Arm Type
Experimental
Arm Description
Medium dose of AU-011 + 1 laser application
Arm Title
Cohort 3 AU-011 & Laser
Arm Type
Experimental
Arm Description
Medium dose of AU-011 + 2 laser applications
Arm Title
Cohort 4 AU-011 & Laser
Arm Type
Experimental
Arm Description
Highest tolerated dose of AU-011/laser applications from Cohorts 1 to 3 administered weekly for 2 treatments
Arm Title
Cohort 5 AU-011 & Laser
Arm Type
Experimental
Arm Description
AU-011/laser applications from Cohorts 1 to 3 administered weekly for 3 treatments. Up to 2 cycles of this regimen may be administered and subjects have the option of receiving a third cycle of treatment.
Arm Title
Cohort 6 AU-011 & Laser
Arm Type
Experimental
Arm Description
High dose of AU-011/laser applications administered weekly for 3 treatments and up to 3 cycles of treatment.
Intervention Type
Drug
Intervention Name(s)
AU-011
Intervention Description
AU-011 Via Suprachoroidal Administration with laser treatment
Intervention Type
Device
Intervention Name(s)
Suprachoroidal Microinjector
Intervention Description
Suprachoroidal Injection Device
Intervention Type
Device
Intervention Name(s)
PDT Laser
Intervention Description
Laser Administration
Primary Outcome Measure Information:
Title
Treatment related AEs and treatment related serious adverse events (SAEs).
Description
Adverse Events
Time Frame
52 weeks
Secondary Outcome Measure Information:
Title
Within-subject difference of historical tumor thickness growth rate and post-treatment growth rate over 52 weeks.
Description
Tumor Thickness Growth Rate
Time Frame
52 weeks
Title
Time to reach tumor progression
Description
Tumor progression
Time Frame
52 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Aura Biosciences
Official's Role
Study Director
Facility Information:
Facility Name
Retina Associates SW, P.C.
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85710
Country
United States
Facility Name
UCLA Jules Stein Eye Institute
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Byers Eye Institute at Stanford University
City
Palo Alto
State/Province
California
ZIP/Postal Code
94303
Country
United States
Facility Name
UCHealth Eye Center
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Retina Associates of Florida
City
Tampa
State/Province
Florida
ZIP/Postal Code
33609
Country
United States
Facility Name
Emory Eye Center
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
University of Illinois At Chicago Illinois Eye and Ear Infirmary
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Midwest Eye Institute
City
Carmel
State/Province
Indiana
ZIP/Postal Code
46290
Country
United States
Facility Name
University of Iowa Department of Ophthalmology and Visual Sciences
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
Massachusetts Eye and Ear Infirmary
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
W. K. Kellogg Eye Center, University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48105
Country
United States
Facility Name
Associated Retinal Consultants, PC
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States
Facility Name
Retina Center
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55404
Country
United States
Facility Name
Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10027
Country
United States
Facility Name
Dean McGee Eye Institute
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Oregon Health & Science University Casey Eye Institute
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Wills Eye Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Retina Consultants of Carolina, PA
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29605
Country
United States
Facility Name
St. Thomas Health / Tennessee Retina, PC
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Texas Retina Associates
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Retina Consultants of Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
University of Wisconsin Dept of Ophthalmology & Visual Sciences
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53705
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
http://www.aurabiosciences.com/
Description
Aura Biosciences

Learn more about this trial

Phase 2 Trial to Evaluate Belzupacap Sarotalocan (AU-011) Via Suprachoroidal Administration in Subjects With Primary Indeterminate Lesions and Small Choroidal Melanoma

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