Clinical Trials
7
Trial Phases
3 Phases
Drug Approvals
0
Drug Approvals
No drug approvals found
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Clinical Trials
Distribution across different clinical trial phases (5 trials with phase data)• Click on a phase to view related trials
Suprachoroidal Administration in Subjects With Choroidal Metastasis From Breast or Lung Primary Tumors
- Conditions
- Eye CancerMetastatic Breast CancerLung Cancer
- Interventions
- First Posted Date
- 2024-10-16
- Last Posted Date
- 2024-10-17
- Lead Sponsor
- Aura Biosciences
- Target Recruit Count
- 24
- Registration Number
- NCT06643884
- Locations
- 🇺🇸
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
A Phase 3 Randomized, Masked, Controlled Trial to Evaluate Efficacy and Safety of Belzupacap Sarotalocan (AU-011) Treatment Compared to Sham Control in Subjects With Primary Indeterminate Lesions or Small Choroidal Melanoma
- Conditions
- Ocular MelanomaUveal MelanomaChoroidal MelanomaIndeterminate Lesions
- Interventions
- Device: Sham Infrared LaserDevice: Suprachoroidal MicroinjectorDevice: Sham MicroinjectorDevice: Infrared Laser
- First Posted Date
- 2023-08-23
- Last Posted Date
- 2025-04-17
- Lead Sponsor
- Aura Biosciences
- Target Recruit Count
- 100
- Registration Number
- NCT06007690
- Locations
- 🇨🇿
Fakultni Thomayerova nemocnice, Praha 4, Krč, Czechia
🇩🇪Charité - Universitätsmedizin Berlin KöR, Berlin, Germany
🇩🇪Universitätsklinikum Schleswig-Holstein Klinik für Augenheilkunde, Lübeck, Germany
A Phase 1, Open-label Trial of Belzupacap Sarotalocan (AU-011) in Bladder Cancer
- Conditions
- Non-muscle-invasive Bladder CancerMuscle-Invasive Bladder Carcinoma
- Interventions
- Combination Product: AU-011 in Combination with Medical Laser AdminstrationCombination Product: AU-011 in Combination with Medical Laser Administration
- First Posted Date
- 2022-08-02
- Last Posted Date
- 2024-06-12
- Lead Sponsor
- Aura Biosciences
- Target Recruit Count
- 21
- Registration Number
- NCT05483868
- Locations
- 🇺🇸
Arkansas Urology, Little Rock, Arkansas, United States
🇺🇸Saint John's Cancer Institute, Santa Monica, California, United States
🇺🇸Montefiore Medical Center, Bronx, New York, United States
Prospective Group-Matched Study With Belzupacap Sarotalocan (Bel-sar; AU-011) or Plaque Radiotherapy for Primary Indeterminate Lesions or Choroidal Melanoma (IL/ CM)
- Conditions
- Choroidal MelanomaIndeterminate Lesions
- Interventions
- Other: Standard of Care
- First Posted Date
- 2022-03-04
- Last Posted Date
- 2023-08-09
- Lead Sponsor
- Aura Biosciences
- Target Recruit Count
- 2
- Registration Number
- NCT05266430
- Locations
- 🇺🇸
Associated Retinal Consultants, P.C., Royal Oak, Michigan, United States
🇺🇸Oregon Health & Science University Casey Eye Institute, Portland, Oregon, United States
🇺🇸Retina Consultants of Carolina, PA, Greenville, South Carolina, United States
Phase 2 Trial to Evaluate Belzupacap Sarotalocan (AU-011) Via Suprachoroidal Administration in Subjects With Primary Indeterminate Lesions and Small Choroidal Melanoma
- Conditions
- Uveal MelanomaOcular MelanomaChoroidal Melanoma
- Interventions
- First Posted Date
- 2020-06-04
- Last Posted Date
- 2025-03-03
- Lead Sponsor
- Aura Biosciences
- Target Recruit Count
- 22
- Registration Number
- NCT04417530
- Locations
- 🇺🇸
Retina Associates SW, P.C., Tucson, Arizona, United States
🇺🇸UCLA Jules Stein Eye Institute, Los Angeles, California, United States
🇺🇸Byers Eye Institute at Stanford University, Palo Alto, California, United States
- Prev
- 1
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- Next
News
Aura Biosciences to Present New Phase 1 Data for Bel-sar in Bladder Cancer at EAU 2025
• Aura Biosciences will present additional Phase 1 clinical data for bel-sar in non-muscle invasive bladder cancer at the upcoming European Association of Urology Congress in Madrid. • The presentation will showcase the latest findings on bel-sar, a novel therapeutic candidate being evaluated for patients with non-muscle invasive bladder cancer. • The company will also participate in the EAU Research Forum, providing an opportunity to engage with leading urological researchers and clinicians.
Aura Biosciences Advances Bel-Sar in Multiple Clinical Trials for Ocular and Bladder Cancers
• Aura Biosciences reports progress in Phase 3 trial for choroidal melanoma with bel-sar, showing an 80% tumor control rate in Phase 2 among Phase 3-eligible patients. • The company is expanding bel-sar's development into bladder cancer, with a Phase 1 trial underway for non-muscle invasive and muscle invasive bladder cancer. • Financial results show increased operating expenses due to manufacturing and personnel growth, with funds expected to support operations into the second half of 2026. • Strategic initiatives include advancing bel-sar across multiple indications and expanding operational capabilities with a new office and laboratory lease in Boston.
Aura Biosciences' Bel-sar Shows Promise in Choroidal Melanoma and Bladder Cancer Trials
• Aura Biosciences reports positive Phase 2 data for bel-sar in early-stage choroidal melanoma, demonstrating 80% tumor control and 90% visual acuity preservation. • Phase 1 trial of bel-sar in NMIBC shows clinical complete response in low-grade disease and immune activation, suggesting potential as a novel immune-ablative treatment. • The Phase 3 CoMpass trial for choroidal melanoma has received EMA authorization to begin enrolling patients in Europe, expanding the trial's global reach. • With a strong cash position, Aura Biosciences expects to fund operations into the second half of 2026, supporting ongoing clinical development programs.
Belzupacap Sarotalocan Shows Promise in Early-Stage Bladder Cancer Trial
• Belzupacap sarotalocan (bel-sar) demonstrates encouraging clinical activity and a favorable safety profile in patients with non-muscle-invasive bladder cancer (NMIBC) in an ongoing phase 1 trial. • In low-grade NMIBC patients treated with light-activated bel-sar, 4 of 5 achieved a complete clinical response, showing no tumor cells detected post-treatment. • The trial observed immune activation in both treated and untreated tumors, suggesting a bladder urothelial field effect with a single low dose of bel-sar. • Aura Biosciences plans to expand the phase 1 trial to optimize dosing and treatment regimens, with potential for a phase 2 registration-supporting trial.
Aura Biosciences' Bel-Sar Shows Promise in Phase 2 for Early-Stage Choroidal Melanoma
• Bel-sar (AU-011) demonstrated an 80% tumor control rate in Phase 2 trial participants with early-stage choroidal melanoma. • The study showed a 90% visual acuity preservation rate among patients treated with bel-sar, offering a vision-sparing alternative to radiation. • The Phase 2 trial highlighted a favorable safety profile for bel-sar, with no serious adverse events reported during the study. • Aura Biosciences is advancing bel-sar into a Phase 3 trial, with potential to become a first-line treatment for choroidal melanoma.