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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
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∙ 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.

Locations
United States
Arizona
East Valley Urology Center
NOT_YET_RECRUITING
Queen Creek
Florida
Florida Urology Partners, LLP
RECRUITING
Tampa
Contact Information
Primary
Jasmine Yang
xu.yang@immviragroup.com
86-512-66202028
Time Frame
Start Date: 2025-06-09
Estimated Completion Date: 2029-05-31
Participants
Target number of participants: 160
Treatments
Experimental: T3011
T3011 will be given once a week (QW) for 6 weeks during the induction treatment course, the following 6 weeks are only for observation and then the 3-month efficacy assessment will be conducted. During the maintenance period, T3011 will be given every 3 weeks (Q3W) until about 24 months or meeting the criteria for treatment discontinuation.
Related Therapeutic Areas
Sponsors
Leads: ImmVira Pharma Co. Ltd

This content was sourced from clinicaltrials.gov

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