Phase 2 Trial of AU-011 Via Suprachoroidal Administration With a Dose Escalation and Randomized, Masked Dose Expansion Designed to Evaluate Safety and Efficacy of AU-011 in Subjects With Primary Indeterminate Lesions and Small Choroidal Melanoma

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Uveal melanoma
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Brief Title

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

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

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.

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 Phase

Phase 2

Study Type

Interventional

Primary Outcome

Treatment related AEs and treatment related serious adverse events (SAEs).

Secondary Outcome

 Within-subject difference of historical tumor thickness growth rate and post-treatment growth rate over 52 weeks.

Condition

Uveal Melanoma

Intervention

AU-011

Study Arms / Comparison Groups

 Cohort 1 AU-011 & Laser
Description:  Low dose of AU-011 + 1 laser application

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Drug

Estimated Enrollment

22

Start Date

August 5, 2020

Completion Date

September 30, 2024

Primary Completion Date

September 30, 2023

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 naïve for IL/CM

        Exclusion Criteria:

          -  Have known contraindications or sensitivities to the study drug or laser

          -  Active ocular disease

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Medical Monitor, 617-500-8864, [email protected]

Location Countries

United States

Location Countries

United States

Administrative Informations

NCT ID

NCT04417530

Organization ID

AU-011-202

Responsible Party

Sponsor

Study Sponsor

Aura Biosciences

Study Sponsor

Medical Monitor, Study Director, Aura Biosciences

Verification Date

November 2022