Safety and Preliminary Anti-Tumor Activity of TYRA-430 in Advanced Hepatocellular Carcinom
A Phase 1 study to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamic (PD), and preliminary antitumor activity of TYRA-430 in cancers with FGF/FGFR pathway aberrations, including locally advanced/metastatic hepatocellular carcinoma and other advanced solid tumors.
| Condition(s) | Metastatic Hepatocellular Carcinoma, Solid Tumors, Solid Tumor, Adult, FGFR Gene Amplification, FGFR Gene Alterations, FGFR3 Gene Alteration, FGFR3 Gene Mutation, Advanced Solid Tumors, FGFR4 Gene Mut |
|---|---|
| Status | Recruiting |
| Phase | Phase 1 |
| Study type | Interventional |
| Summary | A Phase 1 study to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamic (PD), and preliminary antitumor activity of TYRA-430 in cancers with FGF/FGFR pathway aberrations, including locally advanced/metastatic hepatocellular carcinoma and other advanced solid tumors. |
| Who can participate | 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 advanced unresectable/metastatic HCC or histologically confirmed advanced solid tumor with documented FGF/FGFR pathway alterations * For participants with histologically confirmed locally advanced or metastatic HCC: * Barcelona Clinic Liver Cancer (BCLC) stage B that is not eligible for locoregional therapy, or stage C. * Child-Pugh Score class A * Must have previously received SOC appropriate for their tumor type. Any number of prior therapies, including FGFR inhibitors, are permitted. * Agree to p |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Tyra Biosciences, Inc |
| Locations | Los Angeles, California, United States; San Francisco, California, United States; Stanford, California, United States; Westwood, Kansas, United States; Baltimore, Maryland, United States; Boston, Massachusetts, United States (+10 more sites) |
| Start date | 2025-04-24 |
| NCT ID | NCT06915753 |
| Official listing | https://clinicaltrials.gov/study/NCT06915753 |