Ignite Creation Date:
2024-05-06 @ 7:25 PM
Last Modification Date:
2024-10-26 @ 3:06 PM
Study NCT ID:
NCT06007690
Status:
RECRUITING
Last Update Posted:
2024-05-06
First Post:
2023-08-17
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
Sponsor:
Aura Biosciences
Organization:
Aura Biosciences
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CoMpass
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 ILCM 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None