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New targeted drug aims to fight hard-to-treat bladder cancers

NCT ID NCT05544552

Disease control Sponsor: Tyra Biosciences, Inc Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a new drug called TYRA300 in people with advanced bladder cancer or other solid tumors that have a specific change in the FGFR3 gene. The goal is to find the best dose and see if the drug can shrink tumors. About 310 adults whose cancer has not responded to standard treatments will take part.

Why investors are watching

Tyra Biosciences is testing TYRA300, an experimental drug, in people with advanced bladder cancer and other solid tumors that carry specific FGFR3 gene changes. For a small company with few products, this trial's early safety and tumor-shrinking results will largely determine whether the drug has a future and whether the company can move forward.

If it works: If TYRA300 shows clear tumor responses with manageable side effects, Tyra Biosciences could advance the drug to later-stage testing and build a pipeline around it. That outcome would give the company a credible product candidate and a reason for investors to keep following its progress.

If it fails: The trial could show weak effectiveness or safety problems, which would likely end the drug's development and leave the company without a lead program. Trials at this stage often fail, so a negative result is a real possibility.

AI-written from the trial record. Speculative, and not investment advice.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 310 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2022

Expected to finish

Jun 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: Phase 1 Part A and Part B * Men and women 18 years of age or older. * Eastern Cooperative Oncology Group (ECOG) performance status of ≤1. * Histologically confirmed advanced solid tumor who have exhausted standard therapeutic options. * Evaluable (Part A) or measurable (Part B) disease according to RECIST v1.1. * Histologically confirmed advanced solid tumor with an eligible FGFR3 gene mutation or fusion (Part B). Phase 2 * Men and women 18 years of age or older. * ECOG performance status of 0-2 or Karnofsky Performance Scale (KPS) \>70. * At least 1 measurable lesion by RECIST v1.1. * Histologically confirmed locally advanced/metastatic tumor in one of the following categories: * Urothelial carcinoma with an eligible FGFR3 gene mutation or rearrangement who have progressed on a prior FGFR inhibitor and presence of a resistance mutation or other kinase domain mutation. * Urothelial carcinoma with an eligible FGFR3 gene mutation or rearrangement who has not received a prior FGFR inhibitor. * Any solid tumor with an eligible FGFR3 gene mutation or rearrangement. Exclusion Criteria (All Phases): * Has a serum phosphorus level \> upper limit of normal (ULN) during screening that remains \>ULN despite medical management. * Any ocular condition likely to increase the risk of eye toxicity. * History of or current uncontrolled cardiovascular disease. * Active, symptomatic, or untreated brain metastases. * Gastrointestinal disorders that will affect oral administration or absorption of TYRA-300. * Females who are pregnant, breastfeeding, or planning to become pregnant and males who plan to father a child while enrolled in this study.

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Conditions

The condition(s) this trial relates to.

benign urinary system neoplasm bladder transitional cell carcinoma malignant urinary system neoplasm neoplasm Neoplasm Metastasis non-invasive bladder urothelial carcinoma Non-Muscle Invasive Bladder Neoplasms transitional cell carcinoma urinary bladder cancer urinary bladder carcinoma Urinary Bladder Neoplasms urinary system neoplasm urothelial carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Advanced solid tumor Advanced urothelial carcinoma Bladder cancer FGFR3 gene alteration FGFR3 gene mutation Locally advanced urothelial carcinoma Metastatic urothelial carcinoma Non muscle invasive bladder cancer Solid tumor Solid tumor, adult Urinary tract cancer Urinary tract carcinoma Urinary tract tumor Urothelial carcinoma

Contacts and locations

Locations

  • Austin Health

    Heidelberg, Victoria, 3084, Australia

  • Cleveland Clinic - Main Campus

    Cleveland, Ohio, 44195, United States

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02215, United States

  • Duke Cancer Institute (DCI) - Duke Cancer Center

    Durham, North Carolina, 27710, United States

  • Gustave Roussy (Institut de Cancerologie Gustave-Roussy)

    Villejuif, 94805, France

  • Institut Claudius Regaud, IUCT-Oncopole

    Toulouse, 31059, France

  • Institut de Cancerologie de L'Ouest (ICO)

    Saint-Herblain, 44805, France

  • Linear Clinical Research Limited

    Nedlands, Washington, 6009, Australia

  • Macquarie University

    Macquarie Park, New South Wales, 2109, Australia

  • Memorial Sloan Kettering Cancer Center (MSKCC)

    New York, New York, 10021, United States

  • NEXT Barcelona - Hospital Quironsalud Barcelona

    Barcelona, 08023, Spain

  • NEXT Madrid - Hospital Universitario Quironsalud Madrid

    Madrid, 28223, Spain

  • Peter MacCallum Cancer Research Unit

    Melbourne, Victoria, 3000, Australia

  • Princess Alexandra Hospital

    Woolloongabba, Queensland, 4102, Australia

  • Seattle Cancer Care Alliance (SCCA) - South Lake Union

    Seattle, Washington, 98109, United States

  • Tasman Oncology

    Southport, Queensland, 4215, Australia

  • UMass Memorial Medical Center

    Worchester, Massachusetts, 01655, United States

  • Vall d'Hebron Institut d'Oncologia (VHIO)

    Barcelona, 08035, Spain

  • Vanderbilt University Medical Center (VUMC) - Vanderbilt-Ingram Cancer Center (VICC) - Nashville

    Nashville, Tennessee, 37232, United States

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