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Phase 2 Trial to Evaluate Safety and Efficacy of AU-011 Via Suprachoroidal Administration in Subjects With Primary Indeterminate Lesions and Small Choroidal Melanoma

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ClinicalTrials.gov Identifier: NCT04417530
Recruitment Status : Recruiting
First Posted : June 4, 2020
Last Update Posted : March 17, 2021
Sponsor:
Information provided by (Responsible Party):
Aura Biosciences

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 Other: Sham Treatment 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 Dose Expansion Phase Designed to Evaluate the Safety and Efficacy of AU-011 in Subjects With Primary Indeterminate Lesions and Small Choroidal Melanoma.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 31 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: Sequential for dose escalation phase and parallel for randomized dose expansion phase.
Masking: Double (Participant, Outcomes Assessor)
Masking Description: Initial dose escalation phase will be Open Label. The dose expansion phase will be masked to the subject, assessor and sponsor.
Primary Purpose: Treatment
Official Title: 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 Dose Expansion Phase Designed to Evaluate the Safety and Efficacy of AU-011 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


Arm Intervention/treatment
Experimental: Cohort 1 AU-011 & Laser
Single dose of 20 µg of AU-011 + 1 laser application
Drug: AU-011
AU-011 Via Suprachoroidal Administration With a Dose Escalation with laser treatment

Experimental: Cohort 2 AU-011 & Laser
Single dose of 40 µg of AU-011 + 1 laser application
Drug: AU-011
AU-011 Via Suprachoroidal Administration With a Dose Escalation with laser treatment

Experimental: Cohort 3 AU-011 & Laser
Single dose of 40 µg of AU-011 + 2 laser applications
Drug: AU-011
AU-011 Via Suprachoroidal Administration With a Dose Escalation with laser treatment

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 a Dose Escalation with laser treatment

Experimental: Cohort 5 AU-011 & Laser
Highest tolerated dose of AU-011/laser applications from Cohorts 1 to 3 administered weekly for 3 treatments. Up to 2 cycles of this regimen may be administered.
Drug: AU-011
AU-011 Via Suprachoroidal Administration With a Dose Escalation with laser treatment

Cohort 6 AU-011 & Laser or Sham Treatment
Subjects will be randomized in a 1:1 ratio to receive either AU-011 (maximum tolerated dose regimen from Cohorts 1-5) or sham treatment.
Drug: AU-011
AU-011 Via Suprachoroidal Administration With a Dose Escalation with laser treatment

Other: Sham Treatment
Sham treatment includes sham injection and sham laser




Primary Outcome Measures :
  1. Tumor Thickness Growth Rates [ Time Frame: 52 weeks ]
    Tumor Thickness growth rates over 52 weeks



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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 naïve for IL/CM

Exclusion Criteria:

  • Have known contraindications or sensitivities to the study drug or laser
  • Active ocular disease

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
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Contact: Rochelle M Summerfelt, MS 312-613-6006 rsummerfelt@aurabiosciences.com
Contact: Abhijit Narvekar, MBBS 617-319-8580 anarvekar@aurabiosciences.com

Locations
Show Show 19 study locations
Sponsors and Collaborators
Aura Biosciences
Investigators
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Study Director: Abhijit Narvekar, MBBS Aura Biosciences
Additional Information:
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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: March 17, 2021
Last Verified: March 2021
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: No
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