An Open-Label, International, Multicenter Phase II Study to Evaluate the Efficacy and Safety of Intravesical T3011 Injection in Participants With BCG-Unresponsive High-Risk Non-Muscle-Invasive Bladder Cancer (NMIBC) or BCG-Exposed, Chemotherapy-Unresponsive Intermediate /High-Risk NMIBC
This is a Phase II clinical study to evaluate the efficacy and safety of intravesical T3011 injection in participants with BCG-unresponsive high-risk NMIBC or BCG-exposed, chemotherapy-unresponsive intermediate/high-risk NMIBC.
∙ Participants may enter the study only if they meet all the following criteria:
• Male or female, aged ≥18 years at the time of signing the ICF.
• The participants will need to meet the following criteria:
‣ Participants with a histologically confirmed diagnosis of NMIBC (Ta, T1 and/or Cis).
⁃ During the study, the participants must voluntarily comply with the study-specified cystoscopy, urine cytology and randomized biopsy.
• All toxicities caused by prior radiotherapy, chemotherapy or other treatments have recovered to Grade ≤1 (CTCAE 5.0) (except for alopecia), including but not limited to urinary tract infection, urinary tract irritation, and macroscopic hematuria; participants with Grade \>1 anti-neoplastic treatment-related toxicities during the screening period may be enrolled after discussion of the investigators and the sponsor.
• Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2.
• Expected survival ≥24 weeks.
• Laboratory test values meeting the following requirements :
‣ Hematology ANC≥1.5×10\^9/L. PLT count ≥75×10\^9/L. Hemoglobin (HGB) ≥90 g/L.
⁃ Renal function Creatinine clearance ≥60 mL/min (based on Cockcroft-Gault equation for calculation)
⁃ Hepatic function Serum total bilirubin (TBIL) ≤1.5×ULN. Asparate aminotransferase (AST) and alanine transaminase (ALT) ≤2.5×ULN Serum ALB ≥30 g/L.
⁃ Coagulation function International normalized ratio (INR) or prothrombin time (PT) ≤1.5×ULN. Activated partial thromboplastin time (aPTT) ≤1.5×ULN.
• For women of childbearing potential (WOCBP), the serum pregnancy test prior to the first dose must be negative and the potential participant must promise to use medically acceptable and effective methods of contraception. after signing the ICF until at least 6 months after the last dose.
• Male participants of child-bearing potential must agree to use medically acceptable and effective methods of contraception after signing the ICF until at least 6 months after the last dose; in addition, male potential participants must agree not to donate sperm during this period.
• Participants who understand and voluntarily sign the written ICF and are willing and able to comply with all trial requirements.