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Safety and Preliminary Anti-Tumor Activity of TYRA-300 in Advanced Urothelial Carcinoma and Other Solid Tumors With FGFR3 Gene Alterations

NCT05544552 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 310

Last updated 2026-01-12

No results posted yet for this study

Summary

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary antitumor activity of TYRA-300 in cancers with FGFR3 activating gene alterations, including locally advanced/metastatic urothelial carcinoma of the bladder and urinary tract and other advanced solid tumors.

Conditions

  • Locally Advanced Urothelial Carcinoma
  • Metastatic Urothelial Carcinoma
  • Solid Tumor
  • Urothelial Carcinoma
  • Solid Tumor, Adult
  • Bladder Cancer
  • Non-muscle-invasive Bladder Cancer
  • FGFR3 Gene Mutation
  • FGFR3 Gene Alteration
  • Advanced Solid Tumor
  • Advanced Urothelial Carcinoma
  • Urinary Tract Cancer
  • Urinary Tract Tumor
  • Urinary Tract Carcinoma

Interventions

DRUG

TYRA-300

TYRA-300 is an oral, novel potent FGFR 3-selective tyrosine kinase inhibitor that targets tumors that contain activating gene alterations of FGFR3.

Sponsors & Collaborators

  • Tyra Biosciences, Inc

    lead INDUSTRY

Principal Investigators

  • Doug Warner · 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
2022-11-22
Primary Completion
2026-11-30
Completion
2027-06-30
FDA Drug
Yes

Countries

  • United States
  • Australia
  • France
  • Spain

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 NCT05544552 on ClinicalTrials.gov