What is the mechanism of action of this treatment?

Bladder cancer treatments include surgery, chemotherapy, radiation therapy, immunotherapy, and photodynamic therapy (PDT). PDT, similar to AU-011, involves administering a photosensitizing agent that accumulates in cancer cells, followed by exposure to a specific wavelength of light. This activates the agent, producing reactive oxygen species that destroy cancer cells. Understanding these mechanisms helps patients and doctors choose the most effective treatment, anticipate side effects, and tailor therapies to individual patient needs, potentially improving outcomes and quality of life.

What side effects are associated with this type of intervention?

Photodynamic therapy (PDT) for bladder cancer, similar to the AU-011 trial, involves the use of a photosensitizer and a light source to destroy cancer cells. Common side effects of PDT include localized pain, burning sensation, and swelling at the treatment site. Patients may also experience urinary symptoms such as frequency, urgency, and discomfort. Additionally, there is a risk of photosensitivity reactions, where the skin becomes sensitive to light, leading to redness and blistering. These side effects are generally temporary but can vary in severity.

What prior FDA approvals exist?

Photodynamic therapy (PDT) for bladder cancer involves using a photosensitizing agent activated by light to destroy cancer cells. While AU-011 is being studied for its feasibility and safety in bladder cancer treatment, other FDA-approved treatments for bladder cancer include intravesical therapies like Bacillus Calmette-Guérin (BCG) and chemotherapeutic agents such as mitomycin. Additionally, immune checkpoint inhibitors like pembrolizumab and atezolizumab have been approved for advanced or metastatic urothelial carcinoma. These treatments offer various mechanisms to target and manage bladder cancer.

What other types of research exist?

Promising novel alternatives to AU-011 for bladder cancer treatment in 2024 include: 1) Pembrolizumab, an immune checkpoint inhibitor, which has shown efficacy as a second-line therapy for advanced urothelial carcinoma. 2) Nivolumab, another immune checkpoint inhibitor, used in recurrent metastatic urothelial carcinoma. 3) Enfortumab Vedotin, an antibody-drug conjugate, which has demonstrated effectiveness in patients after platinum and anti-PD-1/PD-L1 therapy. 4) Atezolizumab, an anti-PD-L1 therapy, used in patients with platinum-treated locally advanced or metastatic urothelial carcinoma.

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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

No Placebo-Only Group

Summary

This trial is testing a new treatment called AU-011 for bladder cancer. The treatment involves injecting the drug directly into the tumor, and sometimes using a laser to make it work better. The goal is to see if this method is safe and effective for patients.

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.

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.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Safety of AU-011: Incidences of SAEs and DLTs

Secondary study objectives

Assessment of tumor necrosis

Distribution of AU-011

Safety of the laser device

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

AU-011

2020

Completed Phase 2

~30

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Bladder cancer treatments include surgery, chemotherapy, radiation therapy, immunotherapy, and photodynamic therapy (PDT). PDT, similar to AU-011, involves administering a photosensitizing agent that accumulates in cancer cells, followed by exposure to a specific wavelength of light. This activates the agent, producing reactive oxygen species that destroy cancer cells. Understanding these mechanisms helps patients and doctors choose the most effective treatment, anticipate side effects, and tailor therapies to individual patient needs, potentially improving outcomes and quality of life.

[The role of immunotherapy in the modern treatment of urothelial carcinoma].Targeting EGFR with photodynamic therapy in combination with Erbitux enhances in vivo bladder tumor response.