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Efficacy and Safety of TYRA-300 in Participants With FGFR3 Altered Low Grade, Intermediate Risk Non-Muscle Invasive Bladder Cancer

NCT06995677 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2026-05-20

No results posted yet for this study

Summary

Phase 2 Study of TYRA-300 in FGFR3 Altered Low Grade, Intermediate Risk NMIBC

Conditions

  • Low-grade NMIBC
  • FGFR Gene Amplification
  • FGFR Gene Alterations
  • FGFR3 Gene Alteration
  • FGFR3 Gene Mutation
  • FGFR3 Gene Fusions

Interventions

DRUG

TYRA-300 60mg

Self-administered 60mg dose Oral tablet(s) given daily

DRUG

TYRA-300 50mg

Self-administered 50mg dose Oral tablet(s) given daily

DRUG

TYRA-300 Dose TBD

To Be Determined Dose: Self-administered Oral tablet(s) given daily

Sponsors & Collaborators

  • Tyra Biosciences, Inc

    lead INDUSTRY

Principal Investigators

  • Doug Warner, MD · Tyra Biosciences, Inc

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-27
Primary Completion
2028-02-29
Completion
2028-09-30
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Italy
  • Spain

Study Locations

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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 NCT06995677 on ClinicalTrials.gov