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

NCT06915753 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2025-11-20

No results posted yet for this study

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.

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

DRUG

TYRA-430

Oral TYRA-430 given daily.

Sponsors & Collaborators

  • Tyra Biosciences, Inc

    lead INDUSTRY

Principal Investigators

  • Doug Warner, MD · Tyra Biosciences, Inc

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-24
Primary Completion
2028-01-31
Completion
2028-09-30
FDA Drug
Yes

Countries

  • United States
  • Canada
  • South Korea
  • Taiwan

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06915753 on ClinicalTrials.gov