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ACTIVE NOT RECRUITING Phase 1

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

NCT05544552 · View on ClinicalTrials.gov ↗

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

Sponsor

Tyra Biosciences

6 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05544552

The ClinicalTrials.gov registry entry for NCT05544552 describes a study currently listed as active not recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 310 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Tyra Biosciences, which has 6 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05544552 reports 19 study locations spanning 10 distinct geographic areas — top geographies include Other, Massachusetts, Washington. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05544552?

The interventions under investigation include: TYRA-300 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05544552?

This trial is sponsored by Tyra Biosciences, which has 6 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial