Recruiting
Phase 2

TYRA-300

Sponsor:

Tyra Biosciences, Inc

Code:

NCT06995677

Conditions

Low-grade NMIBC

FGFR Gene Amplification

FGFR Gene Alterations

FGFR3 Gene Alteration

FGFR3 Gene Mutation

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

TYRA-300 60mg

TYRA-300 50mg

TYRA-300 Dose TBD

Study Details

Brief summary:

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

Conditions

Low-grade NMIBC

FGFR Gene Amplification

FGFR Gene Alterations

FGFR3 Gene Alteration

FGFR3 Gene Mutation

Study ID

NCT06995677

Start date

Jun 27, 2025

Status verified date

Feb, 2026

Completion date

Sep, 2028

Anticipated

Primary completion date

Feb, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

90 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Dose Cohort A (DCA)

TYRA-300 monotherapy in Participants with FGFR3 Altered Low Grade, Intermediate Risk Non-Muscle Invasive Bladder Cancer

experimental: Dose Cohort B (DCB)

TYRA-300 monotherapy in Participants with FGFR3 Altered Low Grade, Intermediate Risk Non-Muscle Invasive Bladder Cancer

experimental: Possible Dose Cohort C (DCC)

To Be Determined- TYRA-300 monotherapy in Participants with FGFR3 Altered Low Grade, Intermediate Risk Non-Muscle Invasive Bladder Cancer

Interventions

TYRA-300 60mg

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

TYRA-300 50mg

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

TYRA-300 Dose TBD

To Be Determined Dose: Self-administered Oral tablet(s) given daily

Primary outcome measure

  • To assess the efficacy of TYRA-300 in LG IR-NMIBC participants [ Time Frame: at 3 months ]

Central Contacts and Locations

Central contacts

Gina Risdall

619-824-2509TyraClinicalTrials@tyra.bio

Locations

Urology Centers of Alabama

Recruiting

Homewood, Alabama, United States, 35209

Arkansas Urology

Recruiting

Little Rock, Arkansas, United States, 72211

Tri Valley Urology - Murrieta

Recruiting

Murrieta, California, United States, 92562

Eisenhower Medical Associates

Recruiting

Rancho Mirage, California, United States, 92270

Om Research LLC

Recruiting

San Diego, California, United States, 92123

Associated Urological Specialists

Recruiting

Chicago Ridge, Illinois, United States, 60415

Duly Health and Care

Recruiting

Lisle, Illinois, United States, 60532

Urology of Indiana

Recruiting

Greenwood, Indiana, United States, 46143

First Urology

Recruiting

Jeffersonville, Indiana, United States, 47130

University of Kansas Medical Center (KUMC)

Recruiting

Kansas City, Kansas, United States, 66160

Johns Hopkins University

Recruiting

Baltimore, Maryland, United States, 21205

Greater Boston Urology

Recruiting

Plymouth, Massachusetts, United States, 02360

Specialty Clinical Research of St. Louis

Recruiting

St Louis, Missouri, United States, 63141

Atlantic Health System

Recruiting

Morristown, New Jersey, United States, 07960

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

Recruiting

Voorhees Township, New Jersey, United States, 08043

NYU Langone Health

Recruiting

New York, New York, United States, 10016

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

Recruiting

New York, New York, United States, 10065

Associated Medical Professionals of NY

Recruiting

Syracuse, New York, United States, 13210

State University of New York (SUNY) Upstate Medical University

Recruiting

Syracuse, New York, United States, 13210

The Bronx Veterans Medical Research Foundation, Inc.

Recruiting

The Bronx, New York, United States, 10468

Duke Cancer Institute

Recruiting

Durham, North Carolina, United States, 27705

Associate Urologist of North Carolina

Recruiting

Raleigh, North Carolina, United States, 27612

The James at Brain and Spine Hospital (OSU)

Recruiting

Columbus, Ohio, United States, 43210

Oregon Urology Institute

Recruiting

Springfield, Ohio, United States, 97477

MidLantic Urology

Recruiting

Bala-Cynwyd, Pennsylvania, United States, 19004

Keystone Urology Specialists

Recruiting

Lancaster, Pennsylvania, United States, 17604

Medical University of South Carolina

Recruiting

Charleston, South Carolina, United States, 29425

Carolina Urologic Research Center

Recruiting

Myrtle Beach, South Carolina, United States, 29572

Lowcounty Urology Clinics, P.A.

Recruiting

North Charleston, South Carolina, United States, 29406

Conrad Pearson-Memphis

Recruiting

Germantown, Tennessee, United States, 38138

Urology Associates PC

Recruiting

Nashville, Tennessee, United States, 37209

Urology Austin

Recruiting

Austin, Texas, United States, 78759

Urology Clinics of North Texas

Recruiting

Dallas, Texas, United States, 75231

Baylor College of Medicine

Recruiting

Houston, Texas, United States, 77030

Urology San Antonio

Recruiting

San Antonio, Texas, United States, 78229

More Information

Sponsor

Tyra Biosciences, Inc

Last update posted

Aug 6, 2026

Last verified

Feb, 2026

Keywords

  • FGFR3 gene alterations
  • FGFR3 gene mutations
  • FGFR3 gene fusions
  • FGFR3
  • Non-Muscle Invasive Bladder Cancer

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Tyra Biosciences, Inc on 2026-08-06.