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)

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

Tracking Information

• First Submitted Date: August 17, 2023
• First Posted Date: August 23, 2023
• Last Update Posted Date: May 6, 2024
• Actual Study Start Date: December 6, 2023
• Estimated Primary Completion Date: March 1, 2026 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 17, 2023)

Time to reach tumor progression [ Time Frame: 52 weeks ]

Tumor Progression

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: August 17, 2023)

Time to composite endpoint [ Time Frame: 52 weeks ]

Tumor progression or visual acuity failure

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief 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
• 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
• 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).
• 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 Type: Interventional
• Study Phase: Phase 3

Study Design

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Masking Description:

Subject, Assessor, and Sponsor masked trial.

Primary Purpose: Treatment

Condition

• Choroidal Melanoma
• Indeterminate Lesions
• Uveal Melanoma
• Ocular Melanoma

Intervention

• 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
• 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

Study Arms

• Experimental: High dose bel-sar treatment arm & laser application
  High dose of bel-sar + laser application
  Interventions:

  • Drug: Belzupacap Sarotalocan
  • Device: Suprachoroidal Microinjector
  • Device: Infrared Laser
• Experimental: Low dose bel-sar treatment arm & laser application
  Low dose of bel-sar + laser application
  Interventions:

  • Drug: Belzupacap Sarotalocan
  • Device: Suprachoroidal Microinjector
  • Device: Infrared Laser
• Sham Comparator: Sham control arm & sham laser
  Sham dose + sham laser
  Interventions:

  • Device: Sham Infrared Laser
  • Device: Sham Microinjector
  • Drug: Sham Treatment

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: August 17, 2023): 100
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: March 1, 2027
• Estimated Primary Completion Date: March 1, 2026 (Final data collection date for primary outcome measure)

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 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

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

• Listed Location Countries: Australia, United Kingdom, United States

Administrative Information

• NCT Number: NCT06007690
• Other Study ID Numbers: AU-011-301
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• 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

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Aura Biosciences
• Original Responsible Party: Same as current
• Current Study Sponsor: Aura Biosciences
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Medical Monitor; Aura Biosciences

• PRS Account: Aura Biosciences
• Verification Date: May 2024