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Virus Therapy

AU-011 + Laser Therapy for Bladder Cancer

Phase 1

Recruiting

Research Sponsored by Aura Biosciences

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 56 days

Awards & highlights

Study Summary

This trial is testing a new treatment for bladder cancer that involves injecting a drug directly into the bladder wall or tumor. The goal is to see if this is a safe and effective treatment with minimal side effects.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

As this is an early-phase trial primarily assessing safety, specific side effects of AU-011 are being studied but may include typical reactions to injections like pain, swelling, inflammation at the site of injection, and potential effects from laser treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 56 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~56 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 56 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Safety of AU-011: Incidences of SAEs and DLTs

Secondary outcome measures

Assessment of tumor necrosis

Distribution of AU-011

Safety of the laser device

Trial Design

6Treatment groups

Experimental Treatment

Group I: Intratumoral injection of AU-011 with laser application before TURBT (4c)Experimental Treatment1 Intervention

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

Group II: Intratumoral injection of AU-011 with laser application before TURBT (4b)Experimental Treatment1 Intervention

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

Group III: Intratumoral and intramural injection of AU-011 with laser application before TURBT (4a)Experimental Treatment1 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 IV: Intratumoral and intramural injection of AU-011 prior to TURBT (1b)Experimental Treatment1 Intervention

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

Group V: AU-011 intratumoral injection with laser application prior to cystectomy (5b)Experimental Treatment1 Intervention

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

Group VI: AU-011 intratumoral injection with laser application prior to cystectomy (5a)Experimental Treatment1 Intervention

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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Aura BiosciencesLead Sponsor

5 Previous Clinical Trials

681 Total Patients Enrolled

Media Library

AU-011 (Virus Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05483868 — Phase 1

Bladder Cancer Research Study Groups: AU-011 intratumoral injection with laser application prior to cystectomy (5a), Intratumoral and intramural injection of AU-011 with laser application before TURBT (4a), Intratumoral injection of AU-011 with laser application before TURBT (4c), AU-011 intratumoral injection with laser application prior to cystectomy (5b), Intratumoral injection of AU-011 with laser application before TURBT (4b), Intratumoral and intramural injection of AU-011 prior to TURBT (1b)

Bladder Cancer Clinical Trial 2023: AU-011 Highlights & Side Effects. Trial Name: NCT05483868 — Phase 1

AU-011 (Virus Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05483868 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the FDA sanctioned AU-011 for therapeutic use?

"Due to the limited safety and efficacy data available, our team at Power has assigned AU-011 a score of 1 on its safety scale."

Answered by AI

What is the aggregate headcount of participants in this experiment?

"Affirmative. According to clinicaltrials.gov, this trial commenced on September 26th 2022 and was last updated a few days later. Currently, 23 people are required from two medical centres for the study to commence properly."

Answered by AI

Is enrollment to this trial still available?

"Affirmative, the information found on clinicaltrials.gov confirms that this medical trial is presently seeking participants. It was initially launched on September 26th 2022 and has since been refreshed. The experiment needs 23 patients from two respective sites to complete their research."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2022. "A Phase 1, Open-label Trial of Belzupacap Sarotalocan (AU-011) in Bladder Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05483868.