A Study of T3011 in Patients With BCG-Unresponsive NMIBC or BCG-Exposed, Chemotherapy-Unresponsiv… (NCT06971614) | Clinical Trial Compass
RecruitingPhase 2
A Study of T3011 in Patients With BCG-Unresponsive NMIBC or BCG-Exposed, Chemotherapy-Unresponsive NMIBC
United States160 participantsStarted 2025-06-09
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion 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 :
Exclusion criteria
✕. Participants meet the following criteria:
✕. Concurrent or prior history of muscle-invasive (muscularis propria) or metastatic bladder cancer.
✕. Urothelial carcinoma of the upper genitourinary tract or prostatic urethra within 24 months prior to investigational product.
What they're measuring
1
Complete Response Rate in patients with CIS
Timeframe: 3,6,12 months time point from the date of the first dose of T3011
2
Recurrence Free Survival Rate in patients with Ta/T1 (without CIS)
Timeframe: 3,6,12 months time point from the date of the first dose of T3011
3
Incidence rates of Grade ≥3 treatment-related adverse events (TRAEs)
Timeframe: 24 months
4
Incidence rates of TRAEs leading to treatment discontinuation, dose modification or treatment interruption.
. Having received chemotherapy, biotherapy, endocrine therapy, targeted therapy, immunotherapy, investigational product or other anti-neoplastic therapies within 4 weeks prior to investigational product.
✕. Having received radiotherapy within 2 weeks prior to investigational product.
✕. Planning to receive any anti-neoplastic therapy other than the investigational products during this study.
✕. A history of allergic reactions to HSV-1, IL-12, or anti-PD-1 antibodies or biological components similar to them, or known allergic reactions to any component of the T3011 formulation.
✕. A history of brain metastasis or imaging-confirmed brain metastasis , leptomeningeal disease, or spinal cord compression.