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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06915753 | Safety and Preliminary Anti-Tumor Activity of TYRA-430 in Advanced Hepatocellular Carcinoma and Other Solid Tumors With Activating FGF/FGFR Pathway Aberrations | PHASE1 | RECRUITING | 100 | — | — | Apr 24, 2025 | Sep 1, 2028 | Nov 20, 2025 | 16 | United States, Canada +2 |
MTD determination: dose limiting toxicity (DLT) rate in the first 28-day cycle
Number of participants with TEAEs as assessed by CTCAE, v5.0
To determine recommended Phase 2 dose(s) of TYRA-430
| Arm | Type | Description |
|---|---|---|
| Part A - Dose Escalation | EXPERIMENTAL | Dose escalation of TYRA-430 as monotherapy at various dose levels. |
| Part B - Cohort 1 Dose Expansion | EXPERIMENTAL | Dose expansion group for TYRA-430 monotherapy in advanced HCC at a dose(s) determined in Part A. |
| Part B - Cohort 2 Dose Expansion | EXPERIMENTAL | Dose expansion group for TYRA-430 monotherapy in advanced solid tumors at a dose(s) determined in Part A. |
| Name | Type | Description |
|---|---|---|
| TYRA-430 | DRUG | Oral TYRA-430 given daily. |
Key Inclusion Criteria: All Patients: * Age ≥ 18 years * Eastern Cooperative Oncology Group (ECOG) performance status of ≤1. * Adequate end organ function. * Ability to swallow oral formulations. * Ability to understand and willingness to sign the ICF. Part A: * Histologically confirmed locally ...