Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06800963 | ResQ133A-NMIBC: Intravesical Recombinant Mycobacterium (rMBCG) in Participants With NMIBC Eligible to Receive Intravesical Tice BCG | PHASE1 | RECRUITING | 40 | — | — | Oct 15, 2025 | Feb 1, 2028 | Mar 27, 2026 | 9 | United States |
Safety assessments will include demographics/medical history, vital signs, hematology, chemistry, urinalysis, and pregnancy.
| Arm | Type | Description |
|---|---|---|
| Intravesical Recombinant Mycobacterium (rMBCG) | EXPERIMENTAL | Participants will receive an induction course of 1-19.2e8 Colony-forming unit(s) CFU (1 vial) rMBCG via a urinary catheter in the bladder (ie, intravesical administration). |
| Name | Type | Description |
|---|---|---|
| Intravesical Recombinant Mycobacterium (rMBCG) | BIOLOGICAL | 19.2e8 Colony-forming unit(s) CFU (1 vial) rMBCG via a urinary catheter in the bladder (ie, intravesical administration) |
Inclusion Criteria: Participants must meet ALL of the following criteria for inclusion in the study: 1. Male or female participants 18 years of age or older. 2. Histologic confirmation of BCG naïve non-muscle invasive urothelial carcinoma of the bladder (mixed histology tumors allowed if urothelia...