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New pill could fight bladder cancer without surgery

NCT ID NCT06995677

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 study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Sep 10, 2026 · Updated 10 times

Summary

This Phase 2 trial tests an oral drug called TYRA-300 in 90 adults with a low-grade, intermediate-risk bladder cancer that has not invaded muscle. The cancer must have a specific genetic change (FGFR3 alteration). Participants take a daily tablet for up to 2 years. The main goal is to see if the drug can make the tumor disappear completely.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
TYRA-300 (oral tablet)
What this could lead to
If successful, this could provide a new oral treatment option for a specific type of bladder cancer, potentially delaying or avoiding surgery.
What could go wrong
This is an early Phase 2 trial with only 90 participants, so results may not apply to all patients. Side effects are still being studied, and the drug may not work for everyone.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 90 people

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

Started

Jun 2025

Expected to finish

Sep 2028

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: * Participants age 18 and over of informed consent and willing and able to comply with all requires study procedures * Able to understand and given written informed consent * Participants with histologically confirmed low-grade NMIBC within 6 weeks prior to randomization with prior diagnostic biopsy/TURBT to confirm stage and grade and with at least 3 mm and no more than 12 mm total (1/2 a resectoscope loop to 2 loops, refer to Section 8.1.5) residual visible tumor as a marker lesion(s) left behind: 1. Ta low grade 2. T1 low grade * Participants must have intermediate risk NMIBC, defined as having any of the following characteristics (AUA Guidelines, 2024) 1. Recurrence within 1 year, LG Ta 2. Solitary LG Ta \>3cm 3. LG Ta, multifocal 4. LG T1 * Documented activating FGFR3 mutation or fusion (Appendix 4) * Have undergone bladder mapping and identification of visible marker lesion(s) within 6 weeks prior to randomization (refer to Inclusion Criterion #3) * No evidence of urothelial carcinoma of the upper urinary tract (confirmed by imaging) or prostatic urethra within 6 months of randomization * No prior BCG administration within 1 year of date of consent. * No intravesical chemotherapy within 8 weeks prior to C1D1. * ECOG 0-1 * Pathology consistent with pure urothelial carcinoma; if mixed histology, ensure that at least 80% of the sample is urothelial * Adequate bone marrow, liver, and renal function: b. Bone marrow function: i. Absolute neutrophil count (ANC) \> or = 1,500/mm3 ii. Platelet count \> or = 75,000/mm3 iii. /hemoglobin \> or = 10.0 g/dL e. Liver function: i.Total bilirubin \< or = ULN ii. Alanine aminotransferase (ALT) \< or = ULN iii. Aspartate aminotransferase (AST) \< or = ULN f. Renal function: i. estimated glomerular filtration rate \>60 mL/min calculated using the modification of diet in renal disease equation or CKD-EPI formula ii. Serum Phosphate level \< or = ULN prior to starting treatment g. Coagulation i. International normalized ratio (INR) \< or = 1.5 x ULN * Ability to swallow tablets * Participants (male and female) of child-bearing potential (including females who are post-menopausal for less than 1 year) must be willing to practice effective contraception while on treatment and be willing and able to continue contraception for 3 months (males) and 6 months (females) after the last dose of study treatment. Potential male participants should consider the potential impact of TYRA-300 on their ability to father a child and discuss options with the site study staff. * Potential participants who are positive for human immunodeficiency virus (HIV) must have a viral load below the limits of detection and on stable antiretroviral therapy for at least 3 months prior to C1D1. NOTE: some of the compounds in antiretroviral therapy may be on the prohibited medications list. Allowances will be made to ensure the participant's HIV treatment continues uninterrupted following a discussion with the Sponsor's medical monitor. A discussion of the impact of the antiretroviral therapy on TYRA- 300 needs to be discussed with the potential participant prior to C1D1. * Potential participants with chronic hepatitis B virus (HBV) infection with active disease should be on a suppressive antiviral therapy prior to C1D1. * Potential participants patients with a history of hepatitis C virus (HCV) infection should have completed curative antiviral treatment and must have a HCV viral load below the limit of quantification. * Potential participants with a history of HCV infection and on current treatment must have a HCV viral load below the limit of quantification Exclusion Criteria: * Presence of tumor in ureter or prostatic urethra: * Current or previous history of muscle invasive bladder cancer * Current or previous history of lymph node positive and/or metastatic bladder cancer * Evidence of pure squamous cell carcinoma, pure adenocarcinoma or pure undifferentiated carcinoma of the bladder * Currently receiving systemic cancer therapy (cytotoxic, immunotherapy, targeted) * Currently receiving treatment with a prohibited therapy (refer to Section 6.7.1) * Current or prior history of pelvic external beam radiotherapy * Current or history of receiving a prior FGFR inhibitor * Systemic immunotherapy within 6 months prior to randomization * Treatment with an investigational agent within 30 days or 5 half-lives from randomization, whichever is shorter; compounds with an unknown half-life will default to the 30 days. * Prior treatment with an intravesical agent within 8 weeks prior to C1D1 * Current ongoing toxicity from previous therapy * Had major surgery within 4 weeks prior to C1D1 * Any reason that in the view of the investigator, would substantially impair the ability of the participant to comply with study procedures and/or risk to the participant (i.e., uncontrolled diabetes) * Females who are pregnant, breastfeeding or planning to become pregnant within 6 months after the last dose of TYRA-300 and males who plan to father a child while enrolled in this study or within 3 months after the last dose of TYRA-300 * Has impaired wound healing capacity * Serum phosphate levels above the upper limit of normal during screening * Any ocular condition likely to increase the risk of eye toxicity * Current evidence of central serous retinopathy or retinal pigmented epithelial detachment of any grade at time of baseline examination. * History of or current uncontrolled cardiovascular disease * Gastrointestinal disorders that will affect oral administration or absorption of TYRA-300 * Known history of HIV infection, or active hepatitis B or C * History of a second primary malignancy within 3 years of signing ICF, except for nonmelanoma skin cancer and cured and active surveillance malignancies (i.e., prostate, breast) . * Known allergy to TYRA-300 or any excipients of the formulated product * Participants taking strong inhibitors and/or inducers of CYP3A4 enzyme * History of prolonged QT syndrome or baseline heart rate-corrected QT interval using Fridericia formula (QTcF) interval \>470 ms

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Conditions

The condition(s) this trial relates to.

non-invasive bladder urothelial carcinoma Non-Muscle Invasive Bladder Neoplasms

As listed by the trial registrant

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

FGFR gene alterations FGFR gene amplification FGFR3 gene alteration FGFR3 gene fusions FGFR3 gene mutation Low-grade nmibc

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    47 sites in 4 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • ASL Napoli 2 Nord - Ospedale Santa Maria delle Grazie

    RECRUITING

    Pozzuoli, 80078, Italy

  • Arkansas Urology

    RECRUITING

    Little Rock, Arkansas, 72211, United States

  • Associate Urologist of North Carolina

    RECRUITING

    Raleigh, North Carolina, 27612, United States

  • Associated Medical Professionals of NY

    RECRUITING

    Syracuse, New York, 13210, United States

  • Associated Urological Specialists

    RECRUITING

    Chicago Ridge, Illinois, 60415, United States

  • Atlantic Health System

    RECRUITING

    Morristown, New Jersey, 07960, United States

  • Azienda Ospedaliero Universitaria Pisana - Ospedale Santa Chiara

    RECRUITING

    Pisa, 56126, Italy

  • Baylor College of Medicine

    RECRUITING

    Houston, Texas, 77030, United States

  • Carolina Urologic Research Center

    RECRUITING

    Myrtle Beach, South Carolina, 29572, United States

  • Conrad Pearson-Memphis

    RECRUITING

    Germantown, Tennessee, 38138, United States

  • Duke Cancer Institute

    RECRUITING

    Durham, North Carolina, 27705, United States

  • Duly Health and Care

    RECRUITING

    Lisle, Illinois, 60532, United States

  • Eisenhower Medical Associates

    RECRUITING

    Rancho Mirage, California, 92270, United States

  • Epworth Freemasons-Victoria Parade

    RECRUITING

    Richmond, Victoria, 3121, Australia

  • First Urology

    RECRUITING

    Jeffersonville, Indiana, 47130, United States

  • Greater Boston Urology

    RECRUITING

    Plymouth, Massachusetts, 02360, United States

  • Hospital Clínico San Carlos

    WITHDRAWN

    Madrid, Spain, 28040, Spain

  • Hospital Quirón Barcelona

    RECRUITING

    Barcelona, 08908, Spain

  • Hospital Universitario 12 de Oc

    RECRUITING

    Madrid, Spain, 28041, Spain

  • Hospital Universitario Marqués de Valdecilla

    RECRUITING

    Santander, 39008, Spain

  • Hospital Universitario Ramón y Cajal

    RECRUITING

    Madrid, 28034, Spain

  • Hospital del Mar

    RECRUITING

    Barcelona, Spain, 08003, Spain

  • Icahn School of Medicine at Mount Sinai (ISMMS) - Mount Sinai Queens - Infusion Center

    RECRUITING

    Astoria, New York, 11102, United States

  • Istituti Fisioterapici Ospitalieri (IFO)

    RECRUITING

    Rome, Italy, Italy

  • Istituto Europeo di Oncologia

    RECRUITING

    Milan, 20141, Italy

  • Johns Hopkins University

    RECRUITING

    Baltimore, Maryland, 21205, United States

  • Keystone Urology Specialists

    RECRUITING

    Lancaster, Pennsylvania, 17604, United States

  • Lowcounty Urology Clinics, P.A.

    RECRUITING

    North Charleston, South Carolina, 29406, United States

  • MD Anderson Cancer Center - Madrid

    RECRUITING

    Madrid, 28003, Spain

  • Medical University of South Carolina

    RECRUITING

    Charleston, South Carolina, 29425, United States

  • Memorial Sloan Kettering Cancer Center - Sidney Kimmel Center for Prostate and Urologic Cancers

    RECRUITING

    New York, New York, 10065, United States

  • MidLantic Urology

    RECRUITING

    Bala-Cynwyd, Pennsylvania, 19004, United States

  • NYU Langone Health

    RECRUITING

    New York, New York, 10016, United States

  • New Jersey Urology, LLC (Summit Health - Washington Township)

    RECRUITING

    Voorhees Township, New Jersey, 08043, United States

  • Om Research LLC

    RECRUITING

    San Diego, California, 92123, United States

  • Oregon Urology Institute

    RECRUITING

    Springfield, Ohio, 97477, United States

  • Specialty Clinical Research of St. Louis

    RECRUITING

    St Louis, Missouri, 63141, United States

  • State University of New York (SUNY) Upstate Medical University

    RECRUITING

    Syracuse, New York, 13210, United States

  • The Bronx Veterans Medical Research Foundation, Inc.

    RECRUITING

    The Bronx, New York, 10468, United States

  • The James at Brain and Spine Hospital (OSU)

    RECRUITING

    Columbus, Ohio, 43210, United States

  • Tri Valley Urology - Murrieta

    RECRUITING

    Murrieta, California, 92562, United States

  • University of Kansas Medical Center (KUMC)

    RECRUITING

    Kansas City, Kansas, 66160, United States

  • Urology Associates PC

    RECRUITING

    Nashville, Tennessee, 37209, United States

  • Urology Austin

    RECRUITING

    Austin, Texas, 78759, United States

  • Urology Centers of Alabama

    RECRUITING

    Homewood, Alabama, 35209, United States

  • Urology Clinics of North Texas

    RECRUITING

    Dallas, Texas, 75231, United States

  • Urology San Antonio

    RECRUITING

    San Antonio, Texas, 78229, United States

  • Urology of Indiana

    RECRUITING

    Greenwood, Indiana, 46143, United States

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Other studies related to the condition(s) this trial covers.