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A Phase 3 Randomized, Masked, Controlled Trial to Evaluate Efficacy and Safety of Belzupacap Sarotalocan (AU-011) Treatment Compared to Sham Control in Subjects With Primary Indeterminate Lesions or Small Choroidal Melanoma (CoMpass)

Primary Purpose

Choroidal Melanoma, Indeterminate Lesions, Uveal Melanoma

Status
Recruiting
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Belzupacap Sarotalocan
Suprachoroidal Microinjector
Infrared Laser
Sham Infrared Laser
Sham Microinjector
Sham Treatment
Sponsored by
Aura Biosciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Choroidal 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 naive for IL/CM (subjects who received PDT may be eligible) Exclusion Criteria: Have known contraindications or sensitivities to the study drug or laser Active ocular infection or disease

Sites / Locations

  • Retina Consultants of Alabama
  • UCSD Shiley Eye Institute, Jacobs Retina Center
  • Stanford University School of Medicine
  • Retinal Consultants Medical Group, Inc.Recruiting
  • Retina Associates of Florida, PARecruiting
  • Emory Eye Center
  • Northwestern University
  • University of Illinois at Chicago
  • Massachusetts Eye and Ear
  • Ophthalmic Consultants of Boston
  • W.K. Kellogg Eye Center - University of Michigan
  • Associated Retinal Consultants (ARC) P.C.
  • Mayo Clinic
  • The Retina Institute
  • Nebraska Medicine's Truhlsen Eye Institute
  • University of Rochester, Flaum Eye Institute
  • Duke Eye Center
  • Cole Eye Institute
  • Dean McGee Eye Institute
  • Thomas Jefferson University (TJU) - Wills Eye Institute
  • Retina Consultants of CarolinaRecruiting
  • University of Tennessee Hamilton Eye Institute
  • Tennessee Retina, PCRecruiting
  • Austin Retina AssociatesRecruiting
  • Texas Retina AssociatesRecruiting
  • UT, Southwestern Medical Center
  • Retina Associates of South Texas, P.A.
  • Retina Center of Texas
  • Retina Consultants of TexasRecruiting
  • Retina Associates of UtahRecruiting
  • Vitreoretinal Associates of Washington
  • University of Washington Medical Center
  • University of Wisconsin Madison

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Sham Comparator

Arm Label

High dose bel-sar treatment arm & laser application

Low dose bel-sar treatment arm & laser application

Sham control arm & sham laser

Arm Description

High dose of bel-sar + laser application

Low dose of bel-sar + laser application

Sham dose + sham laser

Outcomes

Primary Outcome Measures

Time to reach tumor progression
Tumor Progression

Secondary Outcome Measures

Time to composite endpoint
Tumor progression or visual acuity failure

Full Information

First Posted
August 17, 2023
Last Updated
September 27, 2023
Sponsor
Aura Biosciences
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1. Study Identification

Unique Protocol Identification Number
NCT06007690
Brief Title
A Phase 3 Randomized, Masked, Controlled Trial to Evaluate Efficacy and Safety of Belzupacap Sarotalocan (AU-011) Treatment Compared to Sham Control in Subjects With Primary Indeterminate Lesions or Small Choroidal Melanoma
Acronym
CoMpass
Official Title
A Phase 3 Randomized, Masked, Controlled Trial to Evaluate Efficacy and Safety of Belzupacap Sarotalocan (AU-011) Treatment Compared to Sham Control in Subjects With Primary Indeterminate Lesions or Small Choroidal Melanoma
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 30, 2023 (Anticipated)
Primary Completion Date
March 1, 2026 (Anticipated)
Study Completion Date
March 1, 2027 (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
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The primary objective is to determine the safety and efficacy of belzupacap sarotalocan (bel-sar) compared to sham control in patients with primary indeterminate lesions (IL) or small choroidal melanoma (CM).
Detailed Description
This is a randomized, sham-controlled, subject-, assessor-, and Sponsor- masked trial to establish the safety and efficacy of bel-sar treatment via suprachoroidal (SC) administration in subjects with primary IL/CM. Bel-sar treatment incorporates administration of bel-sar drug product using a suprachoroidal space (SCS) microinjector and activation of bel-sar by a laser photoactivation device.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Masking Description
Subject, Assessor, and Sponsor masked trial.
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
High dose bel-sar treatment arm & laser application
Arm Type
Experimental
Arm Description
High dose of bel-sar + laser application
Arm Title
Low dose bel-sar treatment arm & laser application
Arm Type
Experimental
Arm Description
Low dose of bel-sar + laser application
Arm Title
Sham control arm & sham laser
Arm Type
Sham Comparator
Arm Description
Sham dose + sham laser
Intervention Type
Drug
Intervention Name(s)
Belzupacap Sarotalocan
Other Intervention Name(s)
AU-011, Bel-sar
Intervention Description
Bel-sar via suprachoroidal administration followed by laser application.
Intervention Type
Device
Intervention Name(s)
Suprachoroidal Microinjector
Other Intervention Name(s)
SCS Microinjector
Intervention Description
Suprachoroidal injection device
Intervention Type
Device
Intervention Name(s)
Infrared Laser
Intervention Description
Laser application
Intervention Type
Device
Intervention Name(s)
Sham Infrared Laser
Intervention Description
Sham laser application
Intervention Type
Device
Intervention Name(s)
Sham Microinjector
Intervention Description
Sham injection device
Intervention Type
Drug
Intervention Name(s)
Sham Treatment
Other Intervention Name(s)
Placebo Vehicle
Intervention Description
Sham drug via sham injection followed by sham laser
Primary Outcome Measure Information:
Title
Time to reach tumor progression
Description
Tumor Progression
Time Frame
52 weeks
Secondary Outcome Measure Information:
Title
Time to composite endpoint
Description
Tumor progression or visual acuity failure
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 naive for IL/CM (subjects who received PDT may be eligible) Exclusion Criteria: Have known contraindications or sensitivities to the study drug or laser Active ocular infection or disease
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Medical Monitor
Phone
617-500-8864
Email
clinical@aurabiosciences.com
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 Consultants of Alabama
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
UCSD Shiley Eye Institute, Jacobs Retina Center
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Stanford University School of Medicine
City
Palo Alto
State/Province
California
ZIP/Postal Code
94303
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Retinal Consultants Medical Group, Inc.
City
Sacramento
State/Province
California
ZIP/Postal Code
95825
Country
United States
Individual Site Status
Recruiting
Facility Name
Retina Associates of Florida, PA
City
Tampa
State/Province
Florida
ZIP/Postal Code
33609
Country
United States
Individual Site Status
Recruiting
Facility Name
Emory Eye Center
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
University of Illinois at Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Massachusetts Eye and Ear
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Ophthalmic Consultants of Boston
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02116
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
W.K. Kellogg Eye Center - University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48105
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Associated Retinal Consultants (ARC) P.C.
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
The Retina Institute
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63117
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Nebraska Medicine's Truhlsen Eye Institute
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68105
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
University of Rochester, Flaum Eye Institute
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Duke Eye Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Cole Eye Institute
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Dean McGee Eye Institute
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Thomas Jefferson University (TJU) - Wills Eye Institute
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Retina Consultants of Carolina
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29605
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Tennessee Hamilton Eye Institute
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38103
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Tennessee Retina, PC
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Individual Site Status
Recruiting
Facility Name
Austin Retina Associates
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Individual Site Status
Recruiting
Facility Name
Texas Retina Associates
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Individual Site Status
Recruiting
Facility Name
UT, Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Retina Associates of South Texas, P.A.
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78240
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Retina Center of Texas
City
Southlake
State/Province
Texas
ZIP/Postal Code
76092
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Retina Consultants of Texas
City
The Woodlands
State/Province
Texas
ZIP/Postal Code
77401
Country
United States
Individual Site Status
Recruiting
Facility Name
Retina Associates of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Individual Site Status
Recruiting
Facility Name
Vitreoretinal Associates of Washington
City
Bellevue
State/Province
Washington
ZIP/Postal Code
98004
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
University of Washington Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
University of Wisconsin Madison
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53705
Country
United States
Individual Site Status
Not yet recruiting

12. IPD Sharing Statement

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

Learn more about this trial

A Phase 3 Randomized, Masked, Controlled Trial to Evaluate Efficacy and Safety of Belzupacap Sarotalocan (AU-011) Treatment Compared to Sham Control in Subjects With Primary Indeterminate Lesions or Small Choroidal Melanoma

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