Actively Recruiting
Efficacy and Safety of TYRA-300 in Participants With FGFR3 Altered Low Grade, Intermediate Risk Non-Muscle Invasive Bladder Cancer
Led by Tyra Biosciences, Inc · Updated on 2026-05-14
90
Participants Needed
39
Research Sites
166 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Phase 2 Study of TYRA-300 in FGFR3 Altered Low Grade, Intermediate Risk NMIBC
CONDITIONS
Official Title
Efficacy and Safety of TYRA-300 in Participants With FGFR3 Altered Low Grade, Intermediate Risk Non-Muscle Invasive Bladder Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants aged 18 years or older who can give informed consent and comply with study procedures
- Written informed consent given
- Histologically confirmed low-grade NMIBC within 6 weeks prior to randomization with residual visible tumor measuring between 3 mm and 12 mm
- Tumor stage Ta low grade or T1 low grade
- Intermediate risk NMIBC as defined by AUA Guidelines 2024, including recurrence within 1 year, solitary LG Ta >3cm, multifocal LG Ta, or LG T1
- Documented activating FGFR3 mutation or fusion
- Bladder mapping and identification of visible marker lesion(s) within 6 weeks prior to randomization
- No evidence of urothelial carcinoma of the upper urinary tract or prostatic urethra within 6 months prior to randomization
- No Bacillus Calmette-Guérin (BCG) administration within 1 year prior to consent
- No intravesical chemotherapy within 8 weeks prior to Cycle 1 Day 1
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- Pathology consistent with at least 80% urothelial carcinoma if mixed histology
- Adequate bone marrow, liver, and renal function meeting specified laboratory thresholds
- Ability to swallow tablets
- Willingness to use effective contraception during treatment and for 3 months (males) or 6 months (females) after last dose
- HIV positive participants must have undetectable viral load and be on stable antiretroviral therapy for at least 3 months prior to treatment
- Participants with chronic hepatitis B must be on suppressive antiviral therapy
- Participants with hepatitis C history must have completed curative treatment and have undetectable viral load or be on current treatment with undetectable viral load
You will not qualify if you...
- Tumor present in ureter or prostatic urethra
- History of muscle invasive bladder cancer
- History of lymph node positive or metastatic bladder cancer
- Presence of pure squamous cell carcinoma, pure adenocarcinoma, or pure undifferentiated carcinoma of the bladder
- Currently receiving systemic cancer therapy or prohibited treatments
- History of pelvic external beam radiotherapy
- Previous treatment with an FGFR inhibitor
- Systemic immunotherapy within 6 months prior to randomization
- Treatment with investigational agent within 30 days or 5 half-lives prior to randomization
- Intravesical agent treatment within 8 weeks prior to Cycle 1 Day 1
- Ongoing toxicity from previous therapy
- Major surgery within 4 weeks prior to Cycle 1 Day 1
- Any condition impairing ability to comply with study or posing risk (e.g., uncontrolled diabetes)
- Pregnant or breastfeeding females, or males planning to father a child during or shortly after study
- Impaired wound healing capacity
- Elevated serum phosphate levels during screening
- Ocular conditions increasing risk of eye toxicity or current retinal disorders
- Uncontrolled cardiovascular disease
- Gastrointestinal disorders affecting oral drug absorption
- Known HIV infection or active hepatitis B or C
- History of second primary malignancy within 3 years except certain skin and cured cancers
- Allergy to TYRA-300 or its ingredients
- Use of strong CYP3A4 enzyme inhibitors or inducers
- History of prolonged QT syndrome or QTcF interval >470 ms at baseline
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 39 locations
1
Urology Centers of Alabama
Homewood, Alabama, United States, 35209
Actively Recruiting
2
Arkansas Urology
Little Rock, Arkansas, United States, 72211
Actively Recruiting
3
Tri Valley Urology - Murrieta
Murrieta, California, United States, 92562
Actively Recruiting
4
Om Research LLC
San Diego, California, United States, 92123
Actively Recruiting
5
Associated Urological Specialists
Chicago Ridge, Illinois, United States, 60415
Actively Recruiting
6
Duly Health and Care
Lisle, Illinois, United States, 60532
Actively Recruiting
7
First Urology
Jeffersonville, Indiana, United States, 47130
Actively Recruiting
8
University of Kansas Medical Center (KUMC)
Kansas City, Kansas, United States, 66160
Actively Recruiting
9
Johns Hopkins University
Baltimore, Maryland, United States, 21205
Actively Recruiting
10
Greater Boston Urology
Plymouth, Massachusetts, United States, 02360
Actively Recruiting
11
Atlantic Health System
Morristown, New Jersey, United States, 07960
Actively Recruiting
12
New Jersey Urology, LLC (Summit Health - Washington Township)
Voorhees Township, New Jersey, United States, 08043
Actively Recruiting
13
Memorial Sloan Kettering Cancer Center - Sidney Kimmel Center for Prostate and Urologic Cancers
New York, New York, United States, 10065
Actively Recruiting
14
Associated Medical Professionals of NY
Syracuse, New York, United States, 13210
Actively Recruiting
15
The Bronx Veterans Medical Research Foundation, Inc.
The Bronx, New York, United States, 10468
Actively Recruiting
16
Duke Cancer Institute
Durham, North Carolina, United States, 27705
Actively Recruiting
17
Associate Urologist of North Carolina
Raleigh, North Carolina, United States, 27612
Actively Recruiting
18
Oregon Urology Institute
Springfield, Ohio, United States, 97477
Actively Recruiting
19
MidLantic Urology
Bala-Cynwyd, Pennsylvania, United States, 19004
Actively Recruiting
20
Keystone Urology Specialists
Lancaster, Pennsylvania, United States, 17604
Actively Recruiting
21
Carolina Urologic Research Center
Myrtle Beach, South Carolina, United States, 29572
Actively Recruiting
22
Lowcounty Urology Clinics, P.A.
North Charleston, South Carolina, United States, 29406
Actively Recruiting
23
Conrad Pearson-Memphis
Germantown, Tennessee, United States, 38138
Actively Recruiting
24
Urology Associates PC
Nashville, Tennessee, United States, 37209
Actively Recruiting
25
Urology Austin
Austin, Texas, United States, 78759
Actively Recruiting
26
Baylor College of Medicine
Houston, Texas, United States, 77030
Actively Recruiting
27
Urology San Antonio
San Antonio, Texas, United States, 78229
Actively Recruiting
28
Epworth Freemasons-Victoria Parade
Richmond, Victoria, Australia, 3121
Actively Recruiting
29
Istituti Fisioterapici Ospitalieri (IFO)
Rome, Italy, Italy
Actively Recruiting
30
Istituto Europeo di Oncologia
Milan, Italy, 20141
Actively Recruiting
31
Azienda Ospedaliero Universitaria Pisana - Ospedale Santa Chiara
Pisa, Italy, 56126
Actively Recruiting
32
ASL Napoli 2 Nord - Ospedale Santa Maria delle Grazie
Pozzuoli, Italy, 80078
Actively Recruiting
33
Centro Médico Teknon
Barcelona, Spain, Spain, 08003
Actively Recruiting
34
Hospital Clínico San Carlos
Madrid, Spain, Spain, 28040
Active, Not Recruiting
35
Hospital Universitario 12 de Oc
Madrid, Spain, Spain, 28041
Actively Recruiting
36
Hospital Quirón Barcelona
Barcelona, Spain, 08908
Actively Recruiting
37
MD Anderson Cancer Center - Madrid
Madrid, Spain, 28003
Actively Recruiting
38
Hospital Universitario Ramón y Cajal
Madrid, Spain, 28034
Actively Recruiting
39
Hospital Universitario Marqués de Valdecilla
Santander, Spain, 39008
Actively Recruiting
Research Team
G
Grace Indyk
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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