NCT06643884

Suprachoroidal Administration in Subjects With Metastases to the Choroid

A Phase 2, Open-Label, Dose Escalation Trial Assessing the Safety, Tolerability, and Treatment Effect of Belzupacap Sarotalocan (AU-011) With Suprachoroidal Administration in Subjects With Metastases to the Choroid

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Aura Biosciences · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary objective is to assess the safety and tolerability of bel-sar treatment in subjects with metastases to the choroid from any primary solid tumor.

Detailed description

This is an open-label, dose escalation trial designed to assess safety and tolerability of 4 dose strengths and 1-2 cycles of bel-sar treatment in subjects with metastases to the choroid from any primary solid tumor.

Conditions

• Eye Cancer
• Primary Cancer

Interventions

Type	Name	Description
DRUG	AU-011	AU-011 Via Suprachoroidal Administration with laser treatment
DEVICE	SCS Microinjector	Suprachoroidal Injection Device
DEVICE	Laser	Laser Administration

Timeline

• Start date: 2024-12-16
• Primary completion: 2026-11-30
• Completion: 2027-10-31
• First posted: 2024-10-16
• Last updated: 2026-03-13

Locations

10 sites across 1 country: United States

Regulatory

• FDA-regulated drug study
• FDA-regulated device study