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

Tyra Biosciences, Inc

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.

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.

Eligibility

Age range: 18+ years
Sex: All
Healthy volunteers: No

Detailed criteria

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 locoregio…

Interventions

Drug
TYRA-430
Oral TYRA-430 given daily.

Locations (16)

USC Norris Comprehensive Cancer Center
Los Angeles, California
UCSF Medical Center at Mount Zion
San Francisco, California
Stanford Cancer Institute
Stanford, California
The University of Kansas Medical Center
Westwood, Kansas
John Hopkins University
Baltimore, Maryland
Mass General Cancer Center
Boston, Massachusetts