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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT06007690




Registration number
NCT06007690
Ethics application status
Date submitted
17/08/2023
Date registered
23/08/2023
Date last updated
6/05/2024

Titles & IDs
Public 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
Scientific 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
Secondary ID [1] 0 0
AU-011-301
Universal Trial Number (UTN)
Trial acronym
CoMpass
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Choroidal Melanoma 0 0
Indeterminate Lesions 0 0
Uveal Melanoma 0 0
Ocular Melanoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Malignant melanoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Belzupacap Sarotalocan
Treatment: Devices - Suprachoroidal Microinjector
Treatment: Devices - Infrared Laser
Treatment: Devices - Sham Infrared Laser
Treatment: Devices - Sham Microinjector
Treatment: Drugs - Sham Treatment

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

Experimental: Low dose bel-sar treatment arm & laser application - Low dose of bel-sar + laser application

Sham Comparator: Sham control arm & sham laser - Sham dose + sham laser


Treatment: Drugs: Belzupacap Sarotalocan
Bel-sar via suprachoroidal administration followed by laser application.

Treatment: Devices: Suprachoroidal Microinjector
Suprachoroidal injection device

Treatment: Devices: Infrared Laser
Laser application

Treatment: Devices: Sham Infrared Laser
Sham laser application

Treatment: Devices: Sham Microinjector
Sham injection device

Treatment: Drugs: Sham Treatment
Sham drug via sham injection followed by sham laser
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Time to reach tumor progression
Timepoint [1] 0 0
52 weeks
Secondary outcome [1] 0 0
Time to composite endpoint
Timepoint [1] 0 0
52 weeks

Eligibility
Key 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)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Have known contraindications or sensitivities to the study drug or laser

- Active ocular infection or disease

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
6/12/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/03/2027
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD,VIC
Recruitment hospital [1] 0 0
Terrace Eye Centre - Brisbane
Recruitment hospital [2] 0 0
Eye Research Australia - East Melbourne
Recruitment postcode(s) [1] 0 0
4000 - Brisbane
Recruitment postcode(s) [2] 0 0
3002 - East Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Georgia
Country [6] 0 0
United States of America
State/province [6] 0 0
Illinois
Country [7] 0 0
United States of America
State/province [7] 0 0
Massachusetts
Country [8] 0 0
United States of America
State/province [8] 0 0
Michigan
Country [9] 0 0
United States of America
State/province [9] 0 0
Minnesota
Country [10] 0 0
United States of America
State/province [10] 0 0
Nebraska
Country [11] 0 0
United States of America
State/province [11] 0 0
New York
Country [12] 0 0
United States of America
State/province [12] 0 0
North Carolina
Country [13] 0 0
United States of America
State/province [13] 0 0
Ohio
Country [14] 0 0
United States of America
State/province [14] 0 0
Oklahoma
Country [15] 0 0
United States of America
State/province [15] 0 0
Pennsylvania
Country [16] 0 0
United States of America
State/province [16] 0 0
South Carolina
Country [17] 0 0
United States of America
State/province [17] 0 0
Tennessee
Country [18] 0 0
United States of America
State/province [18] 0 0
Texas
Country [19] 0 0
United States of America
State/province [19] 0 0
Utah
Country [20] 0 0
United States of America
State/province [20] 0 0
Washington
Country [21] 0 0
United States of America
State/province [21] 0 0
Wisconsin
Country [22] 0 0
United Kingdom
State/province [22] 0 0
England
Country [23] 0 0
United Kingdom
State/province [23] 0 0
South Yorkshire

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Aura Biosciences
Address
Country

Ethics approval
Ethics application status

Summary
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).
Trial website
https://clinicaltrials.gov/ct2/show/NCT06007690
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Medical Monitor
Address 0 0
Aura Biosciences
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Medical Monitor
Address 0 0
Country 0 0
Phone 0 0
617-500-8864
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT06007690