Suprachoroidal Administration in Subjects With Choroidal Metastasis From Breast or Lung Primary Tumors

Phase 2

Not yet recruiting

• Conditions: Eye Cancer; Metastatic Breast Cancer; Lung Cancer
• Interventions: Drug: AU-011; Device: SCS Microinjector; Device: Laser

• Registration Number: NCT06643884
• Lead Sponsor: Aura Biosciences

Brief Summary

The primary objective is to assess the safety and tolerability of bel-sar treatment in subjects with choroidal metastasis from breast or lung primary tumors.

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 choroidal metastasis from breast or lung primary tumors.

Study Timeline

• Status Verified: 2024-10
• Study First Submitted: 2024-10-14
• Study First Submitted QC: 2024-10-14
• Study First Posted: 2024-10-16
• Last Update Submitted: 2024-10-16
• Last Update Posted: 2024-10-17
• Study Start: 2024-10-25
• Primary Completion: 2026-01-31
• Study Completion: 2026-12-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

• Have a clinical diagnosis of Choroidal Metastasis, from a histopathologically or cytologically confirmed breast or lung primary tumor.
• Have a single Choroidal Metastasis in only 1 eye, and no Choroidal Metastasis in the other eye (i.e., unilateral, unifocal Choroidal Metastasis).

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Exclusion Criteria

• Active ocular infection or disease.
• Must not have evidence of a primary tumor or metastatic lesion in the brain requiring treatment with radiation therapy per the primary treating oncologist's assessment.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
80 micrograms of bel-sar	AU-011	1 Cycle AU-011 with a dose of 80 micrograms
80 micrograms of bel-sar	SCS Microinjector	1 Cycle AU-011 with a dose of 80 micrograms
80 micrograms of bel-sar	Laser	1 Cycle AU-011 with a dose of 80 micrograms
160 micrograms of bel-sar	AU-011	1 Cycle AU-011 with a dose of 160 micrograms
160 micrograms of bel-sar	SCS Microinjector	1 Cycle AU-011 with a dose of 160 micrograms
160 micrograms of bel-sar	Laser	1 Cycle AU-011 with a dose of 160 micrograms
200 micrograms of bel-sar with one cycle	AU-011	1 Cycle AU-011 with a dose of 200 micrograms
200 micrograms of bel-sar with one cycle	SCS Microinjector	1 Cycle AU-011 with a dose of 200 micrograms
200 micrograms of bel-sar with one cycle	Laser	1 Cycle AU-011 with a dose of 200 micrograms
200 micrograms of bel-sar with two cycles	AU-011	2 Cycles AU-011 with a dose of 200 micrograms
200 micrograms of bel-sar with two cycles	SCS Microinjector	2 Cycles AU-011 with a dose of 200 micrograms
200 micrograms of bel-sar with two cycles	Laser	2 Cycles AU-011 with a dose of 200 micrograms

Primary Outcome Measures

Name	Time	Method
Change from baseline in choroidal tumor thickness on B-scan ultrasonography (B-scan) 4 weeks after completion of treatment.	4 weeks after completion of treatment	B-Scan Ultrasonography
Change from baseline in choroidal tumor largest basal diameter (LBD) on fundus photos 4 weeks after completion of treatment.	4 weeks after completion of treatment	Fundus photos

Trial Locations

Locations (9)

Byers Eye Institute at Stanford University; 🇺🇸 Palo Alto, California, United States

Bascom Palmer Eye Institute; 🇺🇸 Miami, Florida, United States

Massachusetts Eye and Ear; 🇺🇸 Boston, Massachusetts, United States

Kellogg Eye Center; 🇺🇸 Ann Arbor, Michigan, United States

Cleveland Clinic, Cole Eye Institute; 🇺🇸 Cleveland, Ohio, United States

Sheilds and Sheilds, PC; 🇺🇸 Philadelphia, Pennsylvania, United States

Tennessee Retina, PC; 🇺🇸 Nashville, Tennessee, United States

Retina Consultants of Texas; 🇺🇸 Bellaire, Texas, United States

University of Washington; 🇺🇸 Seattle, Washington, United States