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Low-grade NMIBCPhase 2SURF302NCT06995677

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

A Phase 2 study testing TYRA-300 60mg, TYRA-300 50mg and TYRA-300 Dose 70 mg in people with Low-grade NMIBC and FGFR Gene Amplification, run by Tyra Biosciences, Inc at 48 sites in 4 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

Phase 2 Study of TYRA-300 in FGFR3 Altered Low Grade, Intermediate Risk NMIBC Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
TYRA-300 60mg, TYRA-300 50mg and TYRA-300 Dose 70 mg
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
90 participants
Where
48 sitesin 4 countries
Study dates
27 Jun 2025to Sep 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Participants age ≥18 at time of informed consent and willing and able to comply with all required study procedures
  • Able to understand and given written informed consent
  • Participants with histologically confirmed low-grade NMIBC within 8 weeks prior to C1D1 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 8.1.6) residual visible tumor as a marker lesion(s) left behind:
  • Ta low grade
  • T1 low grade
  • Participants must have protocol-defined intermediate risk NMIBC and meet at least one of the following criteria
Show all 25Show fewer
  • Recurrence within 1 year, LG Ta
  • Solitary LG Ta >3cm
  • LG Ta, multifocal
  • LG T1
  • Documented negative voiding urine cytology within 2 weeks of C1D1
  • Documented activating FGFR3 alteration (mutation or fusion)
  • Have undergone bladder mapping and identification of visible marker lesion(s) within 8 weeks prior to C1D1 (refer to Inclusion Criterion #8)
  • No evidence of urothelial carcinoma of the upper urinary tract (confirmed by imaging) or prostatic urethra within 6 months of C1D1.
  • No prior BCG administration within 3 months of the date of most recent consent.
  • No intravesical chemotherapy within 8 weeks prior to C1D1.
  • Eastern Cooperative Oncology Group Performance Status (ECOG PS) 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 as defined as:
  • 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 b. Liver function: i. Total bilirubin < or = ULN ii. Alanine aminotransferase (ALT) < or = ULN iii. Aspartate aminotransferase (AST) < or = ULN c. Renal function: i. estimated glomerular filtration rate >30 mL/min calculated using the modification of diet in renal disease equation or CKD-EPI formula j. Serum Phosphate level < or = ULN d. 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 must refrain from donating sperm until 3 months 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.
  • 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 active hepatitis B virus (HBV) infection should be on a suppressive antiviral therapy prior to C1D1. Note: participants with no history of chronic HBC infection do not need serology testing at Screening.
  • Participants with a history of hepatitis C virus (HCV) infection should have completed curative antiviral treatment or be on stable treatment and must have a HCV viral load below the limit of quantification. Note: participants with no history of chronic HCV infection do not need serology testing at Screening.

Who cannot join

  • 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
  • Current or prior history of pelvic external beam radiotherapy for bladder cancer
Show all 24Show fewer
  • Current or history of receiving a prior FGFR inhibitor
  • Systemic immunotherapy for treatment of cancer within 6 months prior to C1D1
  • Treatment with an investigational agent within 30 days or 5 half-lives from C1D1, 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 a previous bladder cancer therapy or any toxicity that would impact the interpretability of study results per the Investigator's discretion.
  • 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 during Screening as well as any active ocular abnormality at baseline (during Screening) that may increase the chance of ocular toxicity.
  • History of or current uncontrolled cardiovascular disease
  • Gastrointestinal disorders that will affect oral administration or absorption of TYRA-300
  • Other malignancy within 3 years of signing ICF, except for skin cancer (e.g. basal cell, squamous cell, melanoma in situ with negative margins) and cured and/or active surveillance malignancies (i.e., prostate, breast, and others in consultation with the Sponsor).
  • Known allergy to TYRA-300 or any excipients of the formulated product
  • Participants taking moderate and strong inhibitors and/or inducers of CYP3A4 enzyme and inhibitors of P-gp and BCRP.
  • History of prolonged QT syndrome or baseline heart rate-corrected QT interval using Fridericia formula (QTcF) interval >470 ms

Trial locations and contacts

48 sites in 4 countries. Contact the study team or a site near you to ask about taking part.

Gina Risdall contact

619-824-2509

TyraClinicalTrials@tyra.bio

48 sites in 4 countries

United States36 sites, 36 recruiting

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

    Astoria, New York, 11102

    Recruiting

  • Urology Austin

    Austin, Texas, 78759

    Recruiting

  • MidLantic Urology

    Bala-Cynwyd, Pennsylvania, 19004

    Recruiting

  • Johns Hopkins University

    Baltimore, Maryland, 21205

    Recruiting

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

    Recruiting

  • Associated Urological Specialists

    Chicago Ridge, Illinois, 60415

    Recruiting

  • The James at Brain and Spine Hospital (OSU)

    Columbus, Ohio, 43210

    Recruiting

  • Urology Clinics of North Texas

    Dallas, Texas, 75231

    Recruiting

  • Duke Cancer Institute

    Durham, North Carolina, 27705

    Recruiting

  • Conrad Pearson-Memphis

    Germantown, Tennessee, 38138

    Recruiting

  • Urology of Indiana

    Greenwood, Indiana, 46143

    Recruiting

  • Urology Centers of Alabama

    Homewood, Alabama, 35209

    Recruiting

  • Baylor College of Medicine

    Houston, Texas, 77030

    Recruiting

  • First Urology

    Jeffersonville, Indiana, 47130

    Recruiting

  • University of Kansas Medical Center (KUMC)

    Kansas City, Kansas, 66160

    Recruiting

  • Keystone Urology Specialists

    Lancaster, Pennsylvania, 17604

    Recruiting

  • Duly Health and Care

    Lisle, Illinois, 60532

    Recruiting

  • Arkansas Urology

    Little Rock, Arkansas, 72211

    Recruiting

  • Atlantic Health System

    Morristown, New Jersey, 07960

    Recruiting

  • Tri Valley Urology - Murrieta

    Murrieta, California, 92562

    Recruiting

  • Carolina Urologic Research Center

    Myrtle Beach, South Carolina, 29572

    Recruiting

  • Urology Associates PC

    Nashville, Tennessee, 37209

    Recruiting

  • NYU Langone Health

    New York, New York, 10016

    Recruiting

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

    New York, New York, 10065

    Recruiting

  • Lowcounty Urology Clinics, P.A.

    North Charleston, South Carolina, 29406

    Recruiting

  • Greater Boston Urology

    Plymouth, Massachusetts, 02360

    Recruiting

  • Associate Urologist of North Carolina

    Raleigh, North Carolina, 27612

    Recruiting

  • Eisenhower Medical Associates

    Rancho Mirage, California, 92270

    Recruiting

  • Urology San Antonio

    San Antonio, Texas, 78229

    Recruiting

  • Om Research LLC

    San Diego, California, 92123

    Recruiting

  • Oregon Urology Institute

    Springfield, Oregon, 97477

    Recruiting

  • Specialty Clinical Research of St. Louis

    St Louis, Missouri, 63141

    Recruiting

  • Associated Medical Professionals of NY

    Syracuse, New York, 13210

    Recruiting

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

    Syracuse, New York, 13210

    Recruiting

  • The Bronx Veterans Medical Research Foundation, Inc.

    The Bronx, New York, 10468

    Recruiting

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

    Voorhees Township, New Jersey, 08043

    Recruiting

Other trials in United States

Spain7 sites, 6 recruiting

  • Hospital del Mar

    Barcelona, Spain, 08003

    Recruiting

  • Hospital Quirón Barcelona

    Barcelona, 08908

    Recruiting

  • Hospital Clínico San Carlos

    Madrid, Spain, 28040

    Withdrawn

  • Hospital Universitario 12 de Oc

    Madrid, Spain, 28041

    Recruiting

  • MD Anderson Cancer Center - Madrid

    Madrid, 28003

    Recruiting

  • Hospital Universitario Ramón y Cajal

    Madrid, 28034

    Recruiting

  • Hospital Universitario Marqués de Valdecilla

    Santander, 39008

    Recruiting

Other trials in Spain

Italy4 sites, 4 recruiting

  • Istituto Europeo di Oncologia

    Milan, 20141

    Recruiting

  • Azienda Ospedaliero Universitaria Pisana - Ospedale Santa Chiara

    Pisa, 56126

    Recruiting

  • ASL Napoli 2 Nord - Ospedale Santa Maria delle Grazie

    Pozzuoli, 80078

    Recruiting

  • Istituti Fisioterapici Ospitalieri (IFO)

    Rome, Italy

    Recruiting

Other trials in Italy

Australia1 site, 1 recruiting

  • Epworth Freemasons-Victoria Parade

    Richmond, Victoria, 3121

    Recruiting

Other trials in Australia

About this study

Official title: A Phase 2 Multicenter, Open-Label Study Evaluating the Efficacy and Safety of TYRA-300 in Participants With FGFR3 Altered Low Grade, Intermediate Risk Non-Muscle Invasive Bladder Cancer (SURF302)

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

Read the detailed description

A Phase 2 Multicenter, Open-Label Study Evaluating the Efficacy and Safety of TYRA-300 in Participants with FGFR3 Altered Low Grade, Intermediate Risk Non-Muscle Invasive Bladder Cancer

Being tested
TYRA-300 60mg, TYRA-300 50mg, TYRA-300 Dose 70 mg
Keywords
FGFR3 gene alterations, FGFR3 gene mutations, FGFR3 gene fusions, FGFR3, Non-Muscle Invasive Bladder Cancer
Medical subject headings
Non-Muscle Invasive Bladder Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TYRA-300 60mgDrug

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

  • TYRA-300 50mgDrug

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

  • TYRA-300 Dose 70 mgDrug

    Self-administered 70 mg Oral tablet(s) given daily

Study groups in NCT06995677
Study groupRoleWhat they receive
Dose Cohort A (DCA)ExperimentalTYRA-300 monotherapy in Participants with FGFR3 Altered Low Grade, Intermediate Risk Non-Muscle Invasive Bladder Cancer
Receives: Drug: TYRA-300 60mg
Dose Cohort B (DCB)ExperimentalTYRA-300 monotherapy in Participants with FGFR3 Altered Low Grade, Intermediate Risk Non-Muscle Invasive Bladder Cancer
Receives: Drug: TYRA-300 50mg
Possible Dose Cohort C (DCC)ExperimentalTYRA-300 monotherapy in Participants with FGFR3 Altered Low Grade, Intermediate Risk Non-Muscle Invasive Bladder Cancer
Receives: Drug: TYRA-300 Dose 70 mg

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. To assess the efficacy of TYRA-300 in LG IR-NMIBC participants

    Complete response (CR) rate at 3 months

    Measured: at 3 months

Secondary outcomes (7)

  1. Overall CR rate

    Measured: From the start of study treatment up to 24 months

  2. Overall response rate (ORR)

    Measured: From the start of study treatment up to 24 months

  3. Duration of complete response (DOCR) (responders only)

    Measured: Time from initial CR to confirmed recurrence of disease, progression of disease, development of extravesical disease, or death from any cause, whichever comes first, up to 24 months.

  4. Duration of response DOR (responders only)

    Measured: Time from initial response of CR or partial response to confirmed recurrence of disease, progression of disease, development of extravesical disease, or death, from any cause, up to 24 months

  5. Time to recurrence (responders only)

    Measured: Time from start of response to confirmed recurrence of disease or development of extravesical disease, up to 24 months

  6. Recurrence-free rate (responders only)

    Measured: at 12 months and 24 months

  7. Incidence and severity of adverse events

    Measured: Up to 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 May 2025
  2. Study start27 Jun 2025
  3. Primary completionFeb 2028 (estimated)
  4. Study completionSep 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Dose Cohort A will test a TYRA-300 dose of 60mg QD, Dose Cohort B will test, in parallel, a slightly reduced dose of TYRA-300 50 mg QD, and Dose Cohort C will test TYRA-300 at 70mg QD. Dose Cohort C was opened to further explore the safety and efficacy of TYRA-300 based on the emerging safety and efficacy results from Cohorts A and B.
Masking
None (open label)
Enrolment
90 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06995677
Sponsor's protocol ID
TYR300-202
Acronym
SURF302
Status last verified
Feb 2026
First submitted
25 Apr 2025
Last updated
27 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing TYRA-300 60mg, TYRA-300 50mg and TYRA-300 Dose 70 mg in people with Low-grade NMIBC and FGFR Gene Amplification, run by Tyra Biosciences, Inc at 48 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 25 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 48 sites in United States, Spain, Italy, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Gina Risdall (619-824-2509, TyraClinicalTrials@tyra.bio), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To assess the efficacy of TYRA-300 in LG IR-NMIBC participants (time frame: at 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06995677.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026; AzTrials last refreshed its copy on 8 Nov 2026.

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