Suprachoroidal Administration in Subjects With Metastases to the Choroid

Aura Biosciences

Status and phase: Enrolling; Phase 2

Conditions: Eye Cancer; Primary Cancer

Treatments: Device: SCS Microinjector; Device: Laser; Drug: AU-011

Study type: Interventional

Funder types: Industry

Identifiers

NCT06643884

AU-011-203

Details and patient eligibility

About

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.

Full 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.

Enrollment: 24 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Have a clinical diagnosis of Metastases to the Choroid, from a histopathologically or cytologically confirmed tumor.
• Have at least one Metastases to the Choroid in the study eye

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.
• Must not be planning or expecting to switch/add systemic antineoplastic therapies during treatment

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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24 participants in 7 patient groups

80 micrograms of bel-sar

Experimental group

Description:

1 Cycle AU-011 with a dose of 80 micrograms

Treatment:

Drug: AU-011

Device: Laser

Device: SCS Microinjector

140 micrograms of bel-sar

Experimental group

Description:

1 Cycle AU-011 with a dose of 140 micrograms

Treatment:

Drug: AU-011

Device: Laser

Device: SCS Microinjector

200 micrograms of bel-sar with one cycle

Experimental group

Description:

1 Cycle AU-011 with a dose of 200 micrograms

Treatment:

Drug: AU-011

Device: Laser

Device: SCS Microinjector

200 micrograms of bel-sar with two cycles

Experimental group

Description:

2 Cycles AU-011 with a dose of 200 micrograms

Treatment:

Drug: AU-011

Device: Laser

Device: SCS Microinjector

Observational

No Intervention group

Description:

Subjects that meet trial inclusion, but do not meet criteria for enrollment into the bel-sar treatment cohorts, may be enrolled in this cohort. The observational cohort will not receive bel-sar treatment.

40 micrograms of bel-sar with one cycle

Experimental group

Description:

1 Cycle AU-011 with a dose of 40 micrograms

Treatment:

Drug: AU-011

Device: Laser

Device: SCS Microinjector

40 micrograms of bel-sar with two cycles

Experimental group

Description:

2 Cycles AU-011 with a dose of 40 micrograms

Treatment:

Drug: AU-011

Device: Laser

Device: SCS Microinjector