Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Rare Diseases

Melanoma

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Skin Neoplasms

Skin Diseases

Neuroendocrine Tumor

Neuroepithelioma

Patients with primary Choroidal Melanoma and Indeterminate Lesions who have received belzupacap sarotalocan (bel-sar; AU-011) in a previous Aura sponsored clinical trial

Patients who are planned to receive plaque radiotherapy for the treatment of IL/CM based on the expert judgment of the investigator

Standard of Care

AU-011

Medical Monitor

This is a prospective multicenter, group-matched study of patients with primary indeterminate lesions or choroidal melanoma who receive treatment with belzupacap sarotalocan (bel-sar; AU-011) and patients who are planned to receive standard of care (SOC) treatment with plaque radiotherapy (plaque) to compare the visual outcomes of AU-011 and plaque radiotherapy.

Up to approximately 45 patients who are planned to receive plaque radiotherapy for the treatment of IL/CM based on the expert judgment of the Investigator are planned to be enrolled.

Prospective Group-Matched Study With Belzupacap Sarotalocan (Bel-sar; AU-011) or Plaque Radiotherapy for Primary Indeterminate Lesions or Choroidal Melanoma (IL/ CM)

A Prospective Group-Matched Study of Visual Outcomes in Subjects Treated With Belzupacap Sarotalocan (AU-011) or Plaque Radiotherapy for Primary Indeterminate Lesions or Choroidal Melanoma (IL/ CM)

Change from baseline in logMAR visual acuity score at 5 years.

Aura Biosciences

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Carcinoma

Urinary Bladder Neoplasms

Non-Muscle Invasive Bladder Neoplasms

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Urinary Bladder Diseases

Urologic Diseases

Male Urogenital Diseases

Neoplasms, Glandular and Epithelial

Intratumoral (50 μg) and intramural (50 μg) injection of AU-011 prior to the standard of care (TURBT) in patients with NMIBC.

Intratumoral (50 μg) and intramural (50 μg) injection of AU-011 with laser application before standard of care (TURBT) in patients with NMIBC.

Intratumoral injection of AU-011 (100 μg) with laser application before standard of care (TURBT) in patients with NMIBC.

Intratumoral injection of AU-011 (200 μg) with laser application before standard of care (TURBT) in patients with NMIBC.

Intratumoral injection of AU-011 (100 μg) with laser application followed by standard of care (cystectomy) in patients with NMIBC or MIBC.

Intratumoral injection of AU-011 (200 μg) with laser application followed by standard of care (cystectomy) in patients with NMIBC or MIBC.

Administration of AU-011 intratumorally and intramurally

AU-011 in Combination with Medical Laser Adminstration

AU-011 in Combination with Medical Laser Administration

Jerel Johnson

Jennifer Sutton

Mercedes Bruce

Joshua Matson

Sharon Harrison

Ahmad Abdel-Aziz

Karina Lozano

Jose

The main objectives of this study are to determine the feasibility and safety of AU-011 treatment of bladder cancer utilizing intratumoral injection with or without intramural injection and with or without laser application.

Aura is conducting a Phase 1, 'window of opportunity', open-label trial of belzupacap sarotalocan (AU-011) to determine the feasibility and safety of intratumoral injection with or without intramural injection and with or without laser application in subjects with bladder cancer.

A Phase 1, Open-label Trial of Belzupacap Sarotalocan (AU-011) in Bladder Cancer

A Phase 1, Open-label Trial of Belzupacap Sarotalocan (AU-011) to Determine the Feasibility and Safety of Intratumoral Injection With or Without Intramural Injection in Subjects With Bladder Cancer

Incidence and severity of treatment-related adverse events and serious adverse events (SAEs) and incidence of dose-limiting toxicities (DLTs).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Prospective Group-Matched Study With Belzupacap Sarotalocan (Bel-sar; AU-011) or Plaque Radiotherapy for Primary Indeterminate Lesions or Choroidal Melanoma (IL/ CM)	NCT05266430	Choroidal Melan... Indeterminate L...	Standard of Car... AU-011	18 Years -	Aura Biosciences
A Phase 1, Open-label Trial of Belzupacap Sarotalocan (AU-011) in Bladder Cancer	NCT05483868	Non-muscle-inva... Muscle-Invasive...	AU-011 AU-011 in Combi... AU-011 in Combi...	18 Years -	Aura Biosciences

Spots Global Cancer Trial Database for belzupacap sarotalocan