AU-011 + Laser Therapy for Bladder Cancer

Recruiting at 9 trial locations

Overseen By Medical Monitor

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Aura Biosciences

Must not be taking: Immunosuppressants, Steroids

Disqualifiers: Metastatic cancer, Active infections, Autoimmune, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

55 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment called AU-011, combined with laser therapy, to assess its safety and feasibility for treating bladder cancer. The focus is on individuals with non-muscle invasive bladder cancer (NMIBC), meaning the cancer hasn't penetrated the bladder's muscle layer. Participants will receive varying doses and combinations of AU-011 and laser treatment, with some also undergoing TURBT, a surgery to remove bladder tumors. Suitable candidates for this trial have bladder cancer that hasn't spread and haven't shown full resistance to prior BCG treatment, a common bladder cancer therapy. As a Phase 1 trial, this research aims to understand how the treatment works in people, offering participants a chance to be among the first to receive this innovative therapy.

Do I need to stop my current medications for the trial?

The trial protocol does not specify if you need to stop your current medications. However, you cannot participate if you are using systemic immunosuppressants or steroids, or if you have used an investigational drug recently.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that Belzupacap Sarotalocan (AU-011), when combined with laser therapy, was safe in past trials. Patients generally tolerated this treatment well, with studies reporting good tumor control and vision preservation in those with other types of cancer. Although specific side effects in bladder cancer patients remain unspecified, the treatment's history suggests it is manageable. The current phase of research aims to confirm its safety in bladder cancer, and its success in other conditions is a positive sign. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about AU-011 combined with laser therapy for bladder cancer because it offers a novel approach compared to standard treatments like surgery and chemotherapy. AU-011 is unique because it specifically targets tumor cells using a light-activated mechanism, potentially reducing side effects and sparing healthy tissues. Additionally, the option to combine it with transurethral resection of bladder tumor (TURBT) offers flexibility in treatment plans, accommodating both intermediate and high-risk patients with tailored doses. This innovative combination promises a targeted, less invasive alternative that could lead to quicker recovery and improved outcomes for patients.

What evidence suggests that this trial's treatments could be effective for bladder cancer?

Research has shown that AU-011, also known as Belzupacap Sarotalocan, holds promise for treating bladder cancer. Early studies found that in 4 out of 5 cases, patients with intermediate-risk bladder cancer experienced complete responses, meaning the cancer was not detectable after treatment. For high-risk patients, researchers observed strong immune responses, indicating a robust defense against cancer cells. In this trial, participants will receive AU-011 with laser therapy, which may boost the drug's effectiveness by better controlling the tumor. Overall, these findings suggest AU-011 could be effective for different levels of bladder cancer risk. ^{1 5 6 7 8}

Are You a Good Fit for This Trial?

This trial is for individuals with bladder cancer who have not spread beyond the bladder and have normal kidney function. Participants must have a confirmed diagnosis within the last 6 months, no other active cancers except certain skin cancers or treated cervical cancer in remission for at least a year, and cannot be on other investigational drugs or trials.

Inclusion Criteria

My kidney, liver, and bone marrow are functioning well.

I have been diagnosed with bladder cancer confirmed by a biopsy.

My cancer has not spread to other parts of my body.

Exclusion Criteria

I do not have any ongoing infections.

Use of investigational drug or medical device within specified timeframe

I am not currently receiving treatment for any other cancer.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive multiple treatment cycles of focal AU-011 with laser application, with or without TURBT, to evaluate safety and response

12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

What Are the Treatments Tested in This Trial?

Interventions

• AU-011
• AU-011 in Combination with Medical Laser

Trial Overview The study is testing AU-011, an experimental drug for treating bladder cancer. It's given as an injection directly into the tumor alone or combined with a medical laser to see if it's safe and works well.

How Is the Trial Designed?

Group I: Focal injections of AU-011 with laser application before TURBT (4a) Experimental Treatment 1 Intervention

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

Group II: Focal injections of AU-011 prior to TURBT (1b) Experimental Treatment 1 Intervention

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

Group III: Focal injection of AU-011 with laser application before TURBT (4c) Experimental Treatment 1 Intervention

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

Group IV: Focal injection of AU-011 with laser application before TURBT (4b) Experimental Treatment 1 Intervention

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

Group V: Focal injection of AU-011 and laser application with optional TURBT (4g) Experimental Treatment 1 Intervention

Participants with intermediate-risk NMIBC will receive multiple treatment cycles of focal AU-011 (400 µg per lesion) followed by laser activation with the option of TURBT. Participants will be evaluated for safety and response to AU-011 for up to 12 months from initiation of treatment. Enrollment will occur in parallel with Cohort 4e, with randomized (1:1) assignment.

Group VI: Focal injection of AU-011 and laser application with option for TURBT (4h) Experimental Treatment 1 Intervention

Participants with intermediate-risk NMIBC will receive multiple treatment cycles of focal AU-011 (800 ug per lesion) with laser treatment and option for TURBT. Participants will be evaluated for safety and response to AU-011 up to 12 months from initiation of treatment. This arm is optional and will be run at the discretion of the sponsor.

Group VII: Focal injection of AU-011 and laser application with option for TURBT (4e) Experimental Treatment 1 Intervention

Participants with intermediate-risk NMIBC will receive multiple treatment cycles of focal AU-011 (400 µg per lesion) followed by laser activation, with the option for TURBT. Participants will be evaluated for safety and response to AU-011 for up to 12 months from initiation of treatment. Enrollment will occur in parallel with Cohort 4g, with randomized (1:1) assignment.

Group VIII: Focal injection of AU-011 and laser application with option for TURBT (4d) Experimental Treatment 1 Intervention

Participants with intermediate-risk NMIBC will receive multiple treatment cycles of focal AU-011 (200 ug per lesion) with laser treatment and option for TURBT in patients with intermediate risk NMIBC. Participants will be evaluated for safety and response to AU-011 up to 12 months from initiation of treatment.

Group IX: Focal injection of AU-011 and laser application with mandatory TURBT (4i) Experimental Treatment 1 Intervention

Participants with high-risk NMIBC will receive multiple treatment cycles of focal AU-011 (800 µg per lesion) before mandatory TURBT. Participants will be evaluated for safety and response to AU-011 up to 12 months from initiation of treatment. This arm is optional and will be run at the discretion of the sponsor.

Group X: Focal injection of AU-011 and laser application with mandatory TURBT (4f) Experimental Treatment 1 Intervention

Participants with high-risk NMIBC will receive multiple treatment cycles of focal AU-011 (400 µg per lesion) followed by laser activation prior to mandatory TURBT. Participants will be evaluated for safety and response to AU-011 for up to 12 months from initiation of treatment.

Who Is Running the Clinical Trial?

Aura Biosciences

Lead Sponsor

Trials

7

Recruited

730+

Citations

1. aurabiosciences.com aurabiosciences.com/wp-content/uploads/2025/03/EAU25_Late-Breaker-Presentation_March-2025.pdf

Safety and efficacy of Bel-sar (AU-011), a Virus-like-Drug- ... ... Bladder Cancer (NMIBC). Max Kates, M.D., Sabine D. Brookman-May, M.D. ... Efficacy data: Ta Intermediate-Risk NMIBC. 4/5 patients demonstrated CR; 5/5 ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05483868

NCT05483868 | A Phase 1, Open-label Trial of Belzupacap ... The main objectives of this study are to determine the feasibility and safety of Belzupacap Sarotalocan (AU-011, bel-sar) treatment of bladder cancer utilizing ...

3. bcan.org bcan.org/clinicaltrials/au-011-belzupacap-sarotalocan-in-nmibc/

AU-011 (Belzupacap Sarotalocan) in NMIBC The main objectives of this study are to determine the feasibility and safety of Belzupacap Sarotalocan (AU-011, bel-sar) treatment of bladder cancer utilizing ...

4. ir.aurabiosciences.com ir.aurabiosciences.com/news-releases/news-release-details/multiple-clinical-complete-responses-demonstrated-following

Multiple Clinical Complete Responses Demonstrated ... (NASDAQ: AURA), today announced positive early data from an ongoing Phase 1 clinical trial of bel-sar (AU-011) in patients with NMIBC. To ...

5. urologytimes.com urologytimes.com/view/bel-sar-shows-promising-safety-efficacy-in-nmibc

Bel-sar shows promising safety, efficacy in NMIBC Bel-sar showed high complete response rates in intermediate-risk NMIBC patients and significant immune responses in high-risk patients. The drug ...

6. aurabiosciences.com aurabiosciences.com/companynews/aura-biosciences-presents-interim-phase-2-safety-data-evaluating-suprachoroidal-administration-of-au-011-in-patients-with-choroidal-melanoma-at-the-asrs-2021-annual-meeting/

Aura Biosciences Presents Interim Phase 2 Safety Data ... AU-011 was well tolerated in a Phase 1b/2 trial, demonstrating high rates of tumor control and vision preservation. Future pipeline applications for Aura's ...

7. ascopubs.org ascopubs.org/doi/10.1200/JCO.2023.41.6_suppl.TPS596

A phase 1, open-label trial to evaluate feasibility and safety ... This Phase 1 trial is designed to evaluate the feasibility and safety of intramural injection with or without intratumoral injection of belzupacap sarotalocan ...

8. columbusvp.com columbusvp.com/en/aura-biosciences-presents-updated-clinical-data-for-au-011/

Aura Biosciences presents updated clinical data for AU-011 In a Phase 1b/2 study, AU-011 demonstrated compelling efficacy, including high rates of tumor control and vision preservation, along with a favorable safety ...