We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Try the New Site
We're building a modernized ClinicalTrials.gov! Visit Beta.ClinicalTrials.gov to try the new functionality.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04417530
Recruitment Status : Recruiting
First Posted : June 4, 2020
Last Update Posted : December 2, 2022
Sponsor:
Information provided by (Responsible Party):
Aura Biosciences

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
The primary objective is to assess safety and efficacy of AU-011 via suprachoroidal injection to treat primary indeterminate lesions and small choroidal melanoma.

Condition or disease Intervention/treatment Phase
Uveal Melanoma Ocular Melanoma Choroidal Melanoma Drug: AU-011 Device: Suprachoroidal Microinjector Device: PDT Laser Phase 2

Detailed Description:
A Phase 2 Trial of AU-011 Via Suprachoroidal Administration With a Dose Escalation Phase (Open-label, Ascending Single and Repeat Dose) and a Randomized, Masked Confirmatory Phase Designed to Evaluate the Safety and Efficacy of AU-011 in Subjects With Primary Indeterminate Lesions and Small Choroidal Melanoma.
Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 22 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : August 5, 2020
Estimated Primary Completion Date : September 30, 2023
Estimated Study Completion Date : September 30, 2024

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Melanoma
MedlinePlus related topics: Melanoma

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Cohort 1 AU-011 & Laser
Low dose of AU-011 + 1 laser application
 Drug: AU-011
AU-011 Via Suprachoroidal Administration with laser treatment

Device: Suprachoroidal Microinjector
Suprachoroidal Injection Device

Device: PDT Laser
Laser Administration
Experimental: Cohort 2 AU-011 & Laser
Medium dose of AU-011 + 1 laser application
 Drug: AU-011
AU-011 Via Suprachoroidal Administration with laser treatment

Device: Suprachoroidal Microinjector
Suprachoroidal Injection Device

Device: PDT Laser
Laser Administration
Experimental: Cohort 3 AU-011 & Laser
Medium dose of AU-011 + 2 laser applications
 Drug: AU-011
AU-011 Via Suprachoroidal Administration with laser treatment

Device: Suprachoroidal Microinjector
Suprachoroidal Injection Device

Device: PDT Laser
Laser Administration
Experimental: Cohort 4 AU-011 & Laser
Highest tolerated dose of AU-011/laser applications from Cohorts 1 to 3 administered weekly for 2 treatments
 Drug: AU-011
AU-011 Via Suprachoroidal Administration with laser treatment

Device: Suprachoroidal Microinjector
Suprachoroidal Injection Device

Device: PDT Laser
Laser Administration
Experimental: Cohort 5 AU-011 & Laser
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.
 Drug: AU-011
AU-011 Via Suprachoroidal Administration with laser treatment

Device: Suprachoroidal Microinjector
Suprachoroidal Injection Device

Device: PDT Laser
Laser Administration
Experimental: Cohort 6 AU-011 & Laser
High dose of AU-011/laser applications administered weekly for 3 treatments and up to 3 cycles of treatment.
 Drug: AU-011
AU-011 Via Suprachoroidal Administration with laser treatment

Device: Suprachoroidal Microinjector
Suprachoroidal Injection Device

Device: PDT Laser
Laser Administration


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Treatment related AEs and treatment related serious adverse events (SAEs). [ Time Frame: 52 weeks ]
    Adverse Events


Secondary Outcome Measures :
  1. Within-subject difference of historical tumor thickness growth rate and post-treatment growth rate over 52 weeks. [ Time Frame: 52 weeks ]
    Tumor Thickness Growth Rate

  2. Time to reach tumor progression [ Time Frame: 52 weeks ]
    Tumor progression


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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 naïve for IL/CM

Exclusion Criteria:

  • Have known contraindications or sensitivities to the study drug or laser
  • Active ocular disease
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT04417530


Contacts
Layout table for location contacts
Contact: Medical Monitor 617-500-8864 clinical@aurabiosciences.com

Locations
Show Show 22 study locations
Sponsors and Collaborators
Aura Biosciences
Investigators
Layout table for investigator information
Study Director: Medical Monitor Aura Biosciences
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Additional Information:

Layout table for additonal information
Responsible Party: Aura Biosciences
ClinicalTrials.gov Identifier: NCT04417530    
Other Study ID Numbers: AU-011-202
First Posted: June 4, 2020    Key Record Dates
Last Update Posted: December 2, 2022
Last Verified: November 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
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
Keywords provided by Aura Biosciences:
Uveal Melanoma
Eye Cancer
Ocular Melanoma
Choroidal Melanoma
Additional relevant MeSH terms:
Layout table for MeSH terms
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
 Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas