Evaluation of NanoDoce® in Participants With Urothelial Carcinoma

Phase 1/2 Trial Evaluating the Safety and Tolerability of NanoDoce® Injection and Intravesical Instillation in Subjects With Urothelial Carcinoma

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.

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 or Maintenance intravesical instillations.

Inclusion Criteria:

• Signed informed consent;

• Age ≥18 years;

• Patients with either:

  • High-risk Non-Muscle Invasive Bladder Cancer (NMIBC);
  • Muscle Invasive Bladder Cancer (MIBC);

• Urothelial carcinoma confirmed by biopsy, urine cytology, computed tomography scan (CT) or other institution-approved diagnostic methodology;

• All visible tumors removed during bladder resection (TURBT);

• Performance Status (ECOG) 0-2 at study entry;

• Life expectancy of at least 6 months;

• Adequate marrow, liver, and renal function;

  • ANC ≥ 1.5 x 10^9/L;
  • Hemoglobin ≥ 9.5 grams/dL;
  • Platelets ≥ 75 x 10^9/L;
  • Total bilirubin ≤ 1.5x institutional ULN;
  • AST/ ALT ≤ 2.5x institutional ULN;
  • Creatinine ≤ 1.5x institutional ULN;

• Adequate method of birth control.

Exclusion Criteria:

• Metastatic disease;
• Previous (within 12 months) or concurrent history of non-bladder malignancy, except for non-melanoma skin cancer;
• Intravesical therapy within 6 weeks prior to consent (chemotherapy or immunotherapy including BCG administered directly into the bladder);
• Resection surface area greater than 8 cm2;
• Upper tract and urethral disease within 18 months;
• Known hypersensitivity to any of the study drug components or reconstitution components;
• Pregnant or breastfeeding;
• Participation in the treatment phase of another clinical trial within 3 months prior to consent;
• Investigator's opinion of subject's probable noncompliance or inability to understand the trial and/or give adequate informed consent;
• Ongoing drug or alcohol abuse.