AU-011 + Laser Therapy for Bladder Cancer
Recruiting in Palo Alto (17 mi)
+7 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 1
Recruiting
Sponsor: Aura Biosciences
No Placebo Group
Trial Summary
What is the purpose of this trial?
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.
Research Team
Eligibility Criteria
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.
See 1 more
Treatment Details
Interventions
- AU-011 (Virus Therapy)
- AU-011 in Combination with Medical Laser (Procedure)
Trial OverviewThe 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.
Participant Groups
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.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Saint John's Cancer InstituteSanta Monica, CA
Baylor College of MedicineHouston, TX
The University of Texas San AntonioSan Antonio, TX
Montefiore Medical CenterBronx, NY
More Trial Locations
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Who Is Running the Clinical Trial?
Aura Biosciences
Lead Sponsor
Trials
7
Patients Recruited
730+