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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06995677 | Efficacy and Safety of TYRA-300 in Participants With FGFR3 Altered Low Grade, Intermediate Risk Non-Muscle Invasive Bladder Cancer | PHASE2 | RECRUITING | 90 | — | — | Jun 27, 2025 | Sep 1, 2028 | May 20, 2026 | 40 | United States, Australia +2 |
Complete response (CR) rate
| Arm | Type | Description |
|---|---|---|
| Dose Cohort A (DCA) | EXPERIMENTAL | TYRA-300 monotherapy in Participants with FGFR3 Altered Low Grade, Intermediate Risk Non-Muscle Invasive Bladder Cancer |
| Dose Cohort B (DCB) | EXPERIMENTAL | TYRA-300 monotherapy in Participants with FGFR3 Altered Low Grade, Intermediate Risk Non-Muscle Invasive Bladder Cancer |
| Possible Dose Cohort C (DCC) | EXPERIMENTAL | To Be Determined- TYRA-300 monotherapy in Participants with FGFR3 Altered Low Grade, Intermediate Risk Non-Muscle Invasive Bladder Cancer |
| Name | Type | Description |
|---|---|---|
| TYRA-300 60mg | DRUG | Self-administered 60mg dose Oral tablet(s) given daily |
| TYRA-300 50mg | DRUG | Self-administered 50mg dose Oral tablet(s) given daily |
| TYRA-300 Dose TBD | DRUG | To Be Determined Dose: Self-administered Oral tablet(s) given daily |
Inclusion Criteria: * Participants age 18 and over of informed consent and willing and able to comply with all requires study procedures * Able to understand and given written informed consent * Participants with histologically confirmed low-grade NMIBC within 6 weeks prior to randomization with pr...