Brief Title: Evaluation of NanoDoce® in Participants With Urothelial Carcinoma

INTRODUCTION

• Org Study ID: NANODOCE-2017-02
• Secondary ID: N/A
• NTC ID: NCT03636256
• Sponsor: NanOlogy, LLC

BRIEF SUMMARY

This is a clinical trial studying the administration of NanoDoce as a direct injection to the
bladder wall immediately after tumor resection and as an intravesical instillation. All
participants will receive NanoDoce, and will be evaluated for safety and tolerability, as
well as the potential effects of NanoDoce on urothelial carcinoma.

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DETAILED DESCRIPTION

In this clinical trial, subjects with high-risk non-muscle invasive bladder cancer (NMIBC) or
muscle invasive bladder cancer (MIBC), will receive NanoDoce. Subjects will be stratified
into two treatment groups, Group 1 (NMIBC) and Group 2 (MIBC). All subjects will receive
NanoDoce injected into the index tumor resection site on the bladder wall, immediately
following transurethral resection of the bladder tumor (TURBT), followed by an initial
NanoDoce intravesical instillation.

Once the TURBT resection site is healed (approximately 1 month), Group 1 (NMIBC) subjects
will proceed to a 3-month Induction period (6 weekly NanoDoce intravesical instillations,
followed by 6 weeks of rest). After the Induction period, following confirmation of
non-recurrence, Group 1 subjects will proceed to a 3-month Maintenance period (3 weekly
NanoDoce intravesical instillations, followed by 9 weeks of rest).

After NanoDoce direct injection and the initial intravesical instillation, Group 2 subjects
will proceed to institutional standard of care and will not receive Induction of Maintenance
intravesical instillations.

• Overall Status
  Recruiting
• Start Date
  April 2, 2019
• Phase
  Phase 1/Phase 2
• Study Type
  Interventional