RECRUITING

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

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Conditions

Non-muscle-invasive Bladder CancerNon-Muscle Invasive Bladder Cancer (&Amp;#34;NMIBC&Amp;#34;) Unresponsive/Intolerant to BCGNMIBCNon-Muscle Invasive Bladder CarcinomaNon-Muscle Invasive Bladder NeoplasmsNon-Muscle Invasive Bladder Urothelial CarcinomaUrothelial Carcinoma BladderTURBTIntramuralAU-011Belzupacap SarotalocanIntratumoralurothelialbladder cancerbel-sar

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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 focal injections with or without laser application.

Official Title

A Phase 1, Open-label Trial of Belzupacap Sarotalocan (AU-011) to Determine the Feasibility and Safety of Intratumoral Injection With or Without Intramural Injection in Subjects With Bladder Cancer

Quick Facts

Study Start:2022-09-26
Study Completion:2027-04
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05483868

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Meet the following histopathologic requirements for urothelial carcinoma:
  2. * For Cohorts 1b, 4a-c:
  3. * Multifocal LG Ta; OR
  4. * Solitary LG Ta \>3 cm; OR
  5. * Low-grade Ta with prior recurrence(s) within 1 year.
  6. * Ta HG papillary disease with or without CIS; OR
  7. * T1 papillary disease with or without CIS
  8. * Participants may be BCG-naïve or may have received prior treatment with BCG for HR or IR NMIBC (BCG-exposed, BCG-failed, BCG-intolerant)
  9. * BCG-refractory participants are excluded. BCG-refractory is defined by the following:
  10. * Persistent HG disease at 6 months following adequate BCG (defined as ≥5/6 induction instillations and ≥2 additional doses, either from re-induction or maintenance), OR
  11. * HG T1 disease at first evaluation (3 months) after BCG, OR
  12. * Persistent CIS that remains despite a second BCG course, OR
  13. * Disease progression in stage or grade during BCG therapy, including maintenance
  14. 2. Have no evidence of current or prior metastatic urothelial carcinoma
  15. 3. Adequate bone marrow, renal, and hepatic function
  1. 1. Any additional malignancy that requires active treatment, unless deemed appropriate after discussion by the Investigator with the trial's Medical Monitor.
  2. 2. Used an investigational drug or medical device within 30 days or 5 half-lives (whichever is longer) of Visit 1 or be concurrently enrolled in another investigational trial.
  3. 3. Active bacterial, fungal, or viral infections - all prior infections must have resolved following optimal therapy and subject must be off all systemic anti-infective agents.
  4. 4. Active autoimmune disease, chronic inflammatory condition, or other conditions (like solid organ transplant or bone marrow allograft) requiring concurrent use of any systemic immunosuppressants or steroids.
  5. 5. Chronic active hepatitis B or C and HIV.

Contacts and Locations

Study Contact

Medical Monitor
CONTACT
617-500-8864
clinical@aurabiosciences.com

Study Locations (Sites)

Arkansas Urology
Little Rock, Arkansas, 72211
United States
Saint John's Cancer Institute
Santa Monica, California, 90404
United States
Montefiore Medical Center
The Bronx, New York, 10461
United States
Carolina Urologic Research Center
Myrtle Beach, South Carolina, 29272
United States
Urology Associates, P.C.
Nashville, Tennessee, 37209
United States
Urology Clinics of North Texas
Dallas, Texas, 75251
United States
Baylor College of Medicine
Houston, Texas, 77030
United States
The University of Texas San Antonio
San Antonio, Texas, 78229
United States
Urology San Antonio/USA Clinical Trials
San Antonio, Texas, 78229
United States
The Urology Place
San Antonio, Texas, 78240
United States

Collaborators and Investigators

Sponsor: Aura Biosciences

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-09-26
Study Completion Date2027-04

Study Record Updates

Study Start Date2022-09-26
Study Completion Date2027-04

Terms related to this study

Keywords Provided by Researchers

  • NMIBC
  • TURBT
  • Intramural
  • AU-011
  • Belzupacap Sarotalocan
  • Intratumoral
  • urothelial
  • bladder cancer
  • bel-sar

Additional Relevant MeSH Terms

  • Non-muscle-invasive Bladder Cancer
  • Non-Muscle Invasive Bladder Cancer (&Amp;#34;NMIBC&Amp;#34;) Unresponsive/Intolerant to BCG
  • NMIBC
  • Non-Muscle Invasive Bladder Carcinoma
  • Non-Muscle Invasive Bladder Neoplasms
  • Non-Muscle Invasive Bladder Urothelial Carcinoma
  • Urothelial Carcinoma Bladder