NCT06915753

Safety and Preliminary Anti-Tumor Activity of TYRA-430 in Advanced Hepatocellular Carcinoma and Other Solid Tumors With Activating FGF/FGFR Pathway Aberrations

A Multicenter, Open-label, First-in-Human Study of TYRA-430 in Advanced Hepatocellular Carcinoma and Other Solid Tumors With Activating FGF/FGFR Pathway Aberrations

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Tyra Biosciences, Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is an open-label, multi-center, first-in-human, Phase 1 global study of TYRA-430, a first-in-class, selective, reversible fibroblast growth factor receptor (FGFR) 4 and 3 inhibitor, in locally advanced/metastatic hepatocellular carcinoma and other advanced solid tumors that contain FGF/FGFR pathway aberrations.

Conditions

• 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 Mutation
• FGFR4 Gene Fusions
• FGF19 Gene Amplification
• FGF19 Gene Overexpression
• FGFR3 Gene Fusions
• Locally Advanced Unresectable Hepatocellular Carcinoma

Interventions

Type	Name	Description
DRUG	TYRA-430	Oral TYRA-430 given daily.

Timeline

• Start date: 2025-04-24
• Primary completion: 2028-01-01
• Completion: 2028-09-01
• First posted: 2025-04-08
• Last updated: 2025-11-20

Locations

16 sites across 4 countries: United States, Canada, South Korea, Taiwan

Regulatory

• FDA-regulated drug study