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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

Primary Investigator
Demirci, Hakan
Status
OPEN TO ACCRUAL
Phase
II
NCT Number
NCT06643884
UM Number
2024.072
Age Group
Adults
Management Group
CTSU - Oncology
Oncology Group
Breast Oncology
ID (Protocol)
52496
Secondary Protocol No
HUM00254323
Scope
Unspecified
Sponsor Type
Industry
Disease Site
Breast
Eye and Orbit
Lung
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.

Eligibility: 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.