Safety and Toxicity Study of Intravesical Instillation of TARA-002 in Adults with High-grade Non-muscle Invasive Bladder Cancer (Phase 1a)

Prior treatment

• Penicillin allergy (subjects with a questionable history of allergy to penicillin or no history of penicillin use will undergo penicillin blood allergy testing prior to inclusion in the study)
• Concomitant prostatic or upper tract urothelial involvement, per Investigator's assessment
• Bladder cancer stage CIS with concomitant T1
  • For more information on eligibility criteria, please contact the sponsor.

Other illness

• Nodal involvement or metastatic disease that existed at any time (past or present disease)
• Bladder cancer stage ≥ T1 within the last 36 months according to central histology review

Other

• Predominant (defined as \> 50%) adenocarcinoma, squamous cell carcinoma, or histological variants including plasmacytoid, sarcomatoid, or squamous components according to central review

• Male or female subjects 18 years of age or older at the time of signing the informed consent
• Subjects who have voluntarily given written informed consent after the nature of the study has been explained according to applicable requirements prior to study entry
• Subjects with a histologically confirmed, high-grade Ta or CIS (including CIS with concomitant Ta) urothelial cell carcinoma of the bladder on central review
• Subjects who are treatment naïve, are unable to obtain intravesical BCG for the treatment of NMIBC, have received at least one dose of intravesical BCG, or at least one dose of intravesical chemotherapy