Clinical trial NCT06643884: Suprachoroidal Administration in Subjects With Choroidal Metastasis From Breast or Lung Primary Tumors
Official title: A Phase 2, Open-Label, Dose Escalation Trial Assessing the Safety, Tolerability, and Treatment Effect of Bel-sar (AU-011) With Suprachoroidal Administration in Subjects With Choroidal Metastasis From Breast or Lung Primary Tumors
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Eye Cancer
Metastatic Breast Cancer
Lung Cancer
Keywords: Choriodal Metastatis
Metastasis to the Choroid
ocular
eye
Lead sponsor: Aura Biosciences
Sponsor class: INDUSTRY
First posted: 2024-10-16
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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).

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.

Primary outcomes:
measure: Change from baseline in choroidal tumor thickness on B-scan ultrasonography (B-scan) 4 weeks after completion of treatment.
timeFrame: 4 weeks after completion of treatment
measure: Change from baseline in choroidal tumor largest basal diameter (LBD) on fundus photos 4 weeks after completion of treatment.
timeFrame: 4 weeks after completion of treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Byers Eye Institute at Stanford University
state: California
city: Miami
country: United States
facility: Bascom Palmer Eye Institute
state: Florida
city: Boston
country: United States
facility: Massachusetts Eye and Ear
state: Massachusetts
city: Ann Arbor
country: United States
facility: Kellogg Eye Center
state: Michigan
city: Cleveland
country: United States
facility: Cleveland Clinic, Cole Eye Institute
state: Ohio
city: Philadelphia
country: United States
facility: Sheilds and Sheilds, PC
state: Pennsylvania
city: Nashville
country: United States
facility: Tennessee Retina, PC
state: Tennessee
city: Bellaire
country: United States
facility: Retina Consultants of Texas
state: Texas
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: Aura Biosciences
name: Medical Monitor
role: STUDY_DIRECTOR
References: