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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)

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ClinicalTrials.gov Identifier: NCT06007690
Recruitment Status : Recruiting
First Posted : August 23, 2023
Last Update Posted : May 6, 2024
Sponsor:
Information provided by (Responsible Party):
Aura Biosciences

Study Description
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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
Choroidal Melanoma Indeterminate Lesions Uveal Melanoma Ocular Melanoma 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
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Study Type : Interventional  (Clinical Trial)
Estimated 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
Actual Study Start Date : December 6, 2023
Estimated Primary Completion Date : March 1, 2026
Estimated Study Completion Date : March 1, 2027

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Melanoma
MedlinePlus related topics: Melanoma

Arms and Interventions
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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 Name: 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 Name: 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 Name: Placebo Vehicle


Outcome Measures
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Primary Outcome Measures :
  1. Time to reach tumor progression [ Time Frame: 52 weeks ]
    Tumor Progression


Secondary Outcome Measures :
  1. Time to composite endpoint [ Time Frame: 52 weeks ]
    Tumor progression or visual acuity failure


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06007690


Contacts
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Contact: Medical Monitor 617-500-8864 clinical@aurabiosciences.com

Locations
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Sponsors and Collaborators
Aura Biosciences
Investigators
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Study Director: Medical Monitor Aura Biosciences
More Information
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Additional Information:

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Responsible Party: Aura Biosciences
ClinicalTrials.gov Identifier: NCT06007690    
Other Study ID Numbers: AU-011-301
First Posted: August 23, 2023    Key Record Dates
Last Update Posted: May 6, 2024
Last Verified: May 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Aura Biosciences:
Uveal Melanoma
Eye Cancer
Ocular Melanoma
Choroidal Melanoma
Additional relevant MeSH terms:
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Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
 Neoplasms, Nerve Tissue
Nevi and Melanomas
Skin Neoplasms
Neoplasms by Site
Skin Diseases