Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
TYRA-430 · 1 trial · 11 indications
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 ...
TYRA-430 is an investigational small molecule drug being developed by Tyra Biosciences, Inc. for metastatic hepatocellular carcinoma and other advanced solid tumors with activating FGF/FGFR pathway aberrations. It is currently in Phase 1 clinical development and is designed to target FGFR4.
TYRA-430 is being studied for the treatment of metastatic hepatocellular carcinoma, including locally advanced unresectable hepatocellular carcinoma, as well as other advanced solid tumors that carry activating FGF/FGFR pathway aberrations. It is an investigational therapy and has not been approved for any indication.
TYRA-430 targets FGFR4, a member of the fibroblast growth factor receptor (FGFR) family. The Phase 1 trial enrolls patients whose tumors have activating FGF/FGFR pathway aberrations, including FGFR4 gene mutations, FGFR4 gene fusions, FGF19 gene amplification, and FGF19 gene overexpression.
TYRA-430 is being developed by Tyra Biosciences, Inc., which trades on the Nasdaq under the ticker TYRA. The company is running the Phase 1 study of the drug in the United States, Canada, South Korea, and Taiwan.
TYRA-430 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. The single ongoing Phase 1 trial is currently recruiting participants and has an planned enrollment of 125 patients.
TYRA-430 is being evaluated in one Phase 1 trial, NCT06915753, titled Safety and Preliminary Anti-Tumor Activity of TYRA-430 in Advanced Hepatocellular Carcinoma and Other Solid Tumors With Activating FGF/FGFR Pathway Aberrations. The trial is recruiting, is controlled, is not randomized or double blinded, and plans to enroll 125 adults aged 18 and older.