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NCT05544552 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study of Solid Tumor and Advanced Solid Tumor, sponsored by Tyra Biosciences.

Active
Registry status
Phase 1
Development phase
310
Enrollment target
19
Study locations

NCT05544552: Active Phase 1 study of Solid Tumor and Advanced Solid Tumor, sponsored by Tyra Biosciences.

NCT05544552 is a Phase 1 study of Solid Tumor and Advanced Solid Tumor that is active but no longer recruiting, run by Tyra Biosciences. The registered enrollment target is 310 participants, above the 220-participant average among 196 other Solid Tumor trials with a reported enrollment target (41% higher). The trial reports 19 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05544552, a Phase 1 study of Solid Tumor and Advanced Solid Tumor, is active but no longer recruiting, sponsored by Tyra Biosciences.

ACTIVE NOT RECRUITING
Registry status
Phase 1
Development phase
310 participants
Enrollment target
19
Study locations

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.

Interventions

  • DRUG TYRA-300

Study Locations (19)

Other

  • Institut de Cancerologie de L'Ouest (ICO) - Saint-Herblain
  • Institut Claudius Regaud, IUCT-Oncopole - Toulouse
  • Gustave Roussy (Institut de Cancerologie Gustave-Roussy) - Villejuif
  • NEXT Barcelona - Hospital Quironsalud Barcelona - Barcelona
  • Vall d'Hebron Institut d'Oncologia (VHIO) - Barcelona
  • NEXT Madrid - Hospital Universitario Quironsalud Madrid - Madrid

Massachusetts

  • Dana Farber Cancer Institute - Boston
  • UMass Memorial Medical Center - Worchester

Washington

  • Seattle Cancer Care Alliance (SCCA) - South Lake Union - Seattle
  • Linear Clinical Research Limited - Nedlands

Queensland

  • Tasman Oncology - Southport
  • Princess Alexandra Hospital - Woolloongabba

Victoria

  • Austin Health - Heidelberg
  • Peter MacCallum Cancer Research Unit - Melbourne

New York

  • Memorial Sloan Kettering Cancer Center (MSKCC) - New York

North Carolina

  • Duke Cancer Institute (DCI) - Duke Cancer Center - Durham

Ohio

  • Cleveland Clinic - Main Campus - Cleveland

Trial Details

FieldValue
Enrollment Target 310 participants
Start Date 2022-11-22
Est. Completion 2027-06
Phase Phase 1
Tyra Biosciences

6 total trials

What the registry record for NCT05544552 still lists

NCT05544552 is an interventional study that assigns participants to a tested intervention. The registered 310 participants enrollment target is mid-sized for trials with a published cap, above the 220-participant average among 196 other Solid Tumor trials with a reported enrollment target (41% higher).

The record links to 10 conditions, with Solid Tumor appearing as the primary indexed condition, and to 1 intervention - of which TYRA-300 is the first listed.

NCT05544552 lists 19 locations in 10 states (Other, Massachusetts, Washington).

Frequently Asked Questions

What is clinical trial NCT05544552 about?

NCT05544552 is a clinical study titled "Safety and Preliminary Anti-Tumor Activity of TYRA-300 in Advanced Urothelial Carcinoma and Other Solid Tumors With FGFR3 Gene Alterations". 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 s...

What is the current status of trial NCT05544552?

This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 310 participants. The study started on 2022-11-22. Estimated completion is 2027-06.

What conditions does trial NCT05544552 study?

This clinical trial studies the following conditions: Solid Tumor, Advanced Solid Tumor, Bladder Cancer, Urothelial Carcinoma, Solid Tumor, Adult.

What interventions are being tested in trial NCT05544552?

The interventions under investigation include: TYRA-300 (DRUG).

Who is sponsoring clinical trial NCT05544552?

This trial is sponsored by Tyra Biosciences, which has 6 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05544552 being conducted?

This trial has 19 study locations across Massachusetts, New York, North Carolina, Ohio, Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Solid Tumor

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT05544552's enrollment target sits among peer trials

310 21st of 196 higher than 176 of 196 other Solid Tumor trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Solid Tumor trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT05544552, the US trial registry maintained by the National Library of Medicine. NCT05544552 (mid enrollment · multi site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.