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CoMpass: 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

Sponsor
Aura Biosciences (Industry)
Overall Status
Recruiting
CT.gov ID
NCT06007690
Collaborator
(none)
100
Enrollment
33
Locations
3
Arms
41
Anticipated Duration (Months)
3
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

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).

Condition or Disease Intervention/Treatment Phase
  • Drug: Belzupacap Sarotalocan
  • Device: Suprachoroidal Microinjector
  • Device: Infrared Laser
  • Device: Sham Infrared Laser
  • Device: Sham Microinjector
  • Drug: Sham Treatment
 Phase 3

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Masking Description:
Subject, Assessor, and Sponsor masked trial.
Primary Purpose:
Treatment
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
Anticipated Study Start Date :
Sep 30, 2023
Anticipated Primary Completion Date :
Mar 1, 2026
Anticipated Study Completion Date :
Mar 1, 2027

Arms and Interventions

Arm Intervention/Treatment
Experimental: High dose bel-sar treatment arm & laser application

High dose of bel-sar + laser application

Drug: Belzupacap Sarotalocan
Bel-sar via suprachoroidal administration followed by laser application.
Other Names:
  • AU-011
  • Bel-sar

    • Device: Suprachoroidal Microinjector
    Suprachoroidal injection device
    Other Names:
  • SCS Microinjector

    • Device: Infrared Laser
    Laser application
    Experimental: Low dose bel-sar treatment arm & laser application

    Low dose of bel-sar + laser application

    Drug: Belzupacap Sarotalocan
    Bel-sar via suprachoroidal administration followed by laser application.
    Other Names:
  • AU-011
  • Bel-sar

    • Device: Suprachoroidal Microinjector
    Suprachoroidal injection device
    Other Names:
  • SCS Microinjector

    • Device: Infrared Laser
    Laser application
    Sham Comparator: Sham control arm & sham laser

    Sham dose + sham laser

    Device: Sham Infrared Laser
    Sham laser application

    Device: Sham Microinjector
    Sham injection device

    Drug: Sham Treatment
    Sham drug via sham injection followed by sham laser
    Other Names:
  • Placebo Vehicle

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Time to reach tumor progression [52 weeks]

      Tumor Progression

    Secondary Outcome Measures

    1. Time to composite endpoint [52 weeks]

      Tumor progression or visual acuity failure

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Retina Consultants of Alabama Birmingham Alabama United States 35233
    2 UCSD Shiley Eye Institute, Jacobs Retina Center La Jolla California United States 92093
    3 Stanford University School of Medicine Palo Alto California United States 94303
    4 Retinal Consultants Medical Group, Inc. Sacramento California United States 95825
    5 Retina Associates of Florida, PA Tampa Florida United States 33609
    6 Emory Eye Center Atlanta Georgia United States 30322
    7 Northwestern University Chicago Illinois United States 60611
    8 University of Illinois at Chicago Chicago Illinois United States 60612
    9 Massachusetts Eye and Ear Boston Massachusetts United States 02114
    10 Ophthalmic Consultants of Boston Boston Massachusetts United States 02116
    11 W.K. Kellogg Eye Center - University of Michigan Ann Arbor Michigan United States 48105
    12 Associated Retinal Consultants (ARC) P.C. Royal Oak Michigan United States 48073
    13 Mayo Clinic Rochester Minnesota United States 55905
    14 The Retina Institute Saint Louis Missouri United States 63117
    15 Nebraska Medicine's Truhlsen Eye Institute Omaha Nebraska United States 68105
    16 University of Rochester, Flaum Eye Institute Rochester New York United States 14642
    17 Duke Eye Center Durham North Carolina United States 27705
    18 Cole Eye Institute Cleveland Ohio United States 44195
    19 Dean McGee Eye Institute Oklahoma City Oklahoma United States 73104
    20 Thomas Jefferson University (TJU) - Wills Eye Institute Philadelphia Pennsylvania United States 19107
    21 Retina Consultants of Carolina Greenville South Carolina United States 29605
    22 University of Tennessee Hamilton Eye Institute Memphis Tennessee United States 38103
    23 Tennessee Retina, PC Nashville Tennessee United States 37203
    24 Austin Retina Associates Austin Texas United States 78705
    25 Texas Retina Associates Dallas Texas United States 75231
    26 UT, Southwestern Medical Center Dallas Texas United States 75390
    27 Retina Associates of South Texas, P.A. San Antonio Texas United States 78240
    28 Retina Center of Texas Southlake Texas United States 76092
    29 Retina Consultants of Texas The Woodlands Texas United States 77401
    30 Retina Associates of Utah Salt Lake City Utah United States 84107
    31 Vitreoretinal Associates of Washington Bellevue Washington United States 98004
    32 University of Washington Medical Center Seattle Washington United States 98104
    33 University of Wisconsin Madison Madison Wisconsin United States 53705

    Sponsors and Collaborators

    • Aura Biosciences

    Investigators

    • Study Director: Medical Monitor, Aura Biosciences

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Aura Biosciences
    ClinicalTrials.gov Identifier:
    NCT06007690
    Other Study ID Numbers:
    • AU-011-301
    First Posted:
    Aug 23, 2023
    Last Update Posted:
    Aug 24, 2023
    Last Verified:
    Aug 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    Yes
    Product Manufactured in and Exported from the U.S.:
    Yes
    Keywords provided by Aura Biosciences
    Uveal Melanoma
    Eye Cancer
    Ocular Melanoma
    Choroidal Melanoma
    Additional relevant MeSH terms:
    Melanoma

    Study Results

    No Results Posted as of Aug 24, 2023