Actively Recruiting
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)
Led by Tyra Biosciences, Inc · Updated on 2026-05-20
90
Participants Needed
40
Research Sites
30 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the efficacy and safety of TYRA-300 in adults with low-grade, intermediate-risk non-muscle invasive bladder cancer (NMIBC) that has specific FGFR3 gene alterations. This Phase 2 multicenter study focuses on patients who have residual visible tumors and meet certain risk criteria, aiming to better understand treatment effects in this particular group. Participants receive self-administered oral tablets of TYRA-300 daily at doses of 50mg, 60mg, or a dose to be determined. The study is randomized and open-label, with three experimental dose cohorts. Treatment continues while monitoring for tumor response and safety over time. During the study, participants will undergo assessments including bladder mapping, tumor evaluations, and laboratory tests to monitor organ function and treatment effects. Researchers will measure tumor response at 3 months, duration of response, time to recurrence, recurrence-free survival, progression-free survival, and safety outcomes up to 2 years. Participants will be followed and monitored regularly throughout the study period.
CONDITIONS
Brief 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 age 18 years and older who can give informed consent and comply with study procedures
- Able to understand and provide written informed consent
- Histologically confirmed low-grade non-muscle invasive bladder cancer (Ta or T1) within 6 weeks prior to randomization
- Residual visible tumor between 3 mm and 12 mm as a marker lesion
- Intermediate risk NMIBC as defined by recurrence within 1 year, solitary tumor larger than 3 cm, multifocal tumor, or T1 low grade
- Documented activating FGFR3 mutation or fusion
- Underwent bladder mapping and identification of visible marker lesion(s) within 6 weeks prior to randomization
- No evidence of urothelial carcinoma of upper urinary tract or prostatic urethra within 6 months
- No prior BCG administration within 1 year before consent
- No intravesical chemotherapy within 8 weeks prior to first treatment day
- ECOG performance status 0-1
- Pathology consistent with at least 80% urothelial carcinoma if mixed histology
- Adequate bone marrow, liver, and renal function as specified
- Ability to swallow tablets
- Willingness to use effective contraception during and after treatment as required
- HIV positive participants must have undetectable viral load and stable antiretroviral therapy
- Participants with chronic hepatitis B or C must meet specific viral load and treatment criteria
You will not qualify if you...
- Presence of tumor in ureter or prostatic urethra
- History or current muscle invasive bladder cancer
- History or current lymph node positive or metastatic bladder cancer
- Pure squamous cell carcinoma, adenocarcinoma, or undifferentiated carcinoma of bladder
- Currently receiving systemic cancer therapy or prohibited therapies
- Prior pelvic radiotherapy
- Prior FGFR inhibitor treatment
- Systemic immunotherapy within 6 months prior to randomization
- Treatment with investigational agents within 30 days or 5 half-lives prior to randomization
- Prior intravesical agent treatment within 8 weeks before first treatment day
- Ongoing toxicity from previous therapy
- Major surgery within 4 weeks prior to first treatment day
- Conditions impairing compliance or increasing risk, such as uncontrolled diabetes
- Pregnant or breastfeeding females, or males planning to father a child during or shortly after treatment
- Impaired wound healing capacity
- Serum phosphate above normal limits
- Eye conditions increasing risk of toxicity or current retinal disorders
- Uncontrolled cardiovascular disease
- Gastrointestinal disorders affecting oral drug absorption
- Known active HIV or hepatitis B or C infection
- Second primary malignancy within 3 years excluding certain skin and surveillance cancers
- Allergy to TYRA-300 or its components
- Use of strong CYP3A4 inhibitors or inducers
- History of prolonged QT syndrome or QTcF interval over 470 ms
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 24 months
Participants receive daily oral doses of TYRA-300 as monotherapy for their bladder cancer.
Visits occur regularly during treatment to assess safety and response
Duration - Up to 24 months after treatment
Participants are monitored for recurrence, progression, and long-term safety after treatment ends.
Periodic visits for safety and efficacy assessments
Trial Site Locations
Total: 40 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
Urology of Indiana
Greenwood, Indiana, United States, 46143
Actively Recruiting
8
First Urology
Jeffersonville, Indiana, United States, 47130
Actively Recruiting
9
University of Kansas Medical Center (KUMC)
Kansas City, Kansas, United States, 66160
Actively Recruiting
10
Johns Hopkins University
Baltimore, Maryland, United States, 21205
Actively Recruiting
11
Greater Boston Urology
Plymouth, Massachusetts, United States, 02360
Actively Recruiting
12
Atlantic Health System
Morristown, New Jersey, United States, 07960
Actively Recruiting
13
New Jersey Urology, LLC (Summit Health - Washington Township)
Voorhees Township, New Jersey, United States, 08043
Actively Recruiting
14
Memorial Sloan Kettering Cancer Center - Sidney Kimmel Center for Prostate and Urologic Cancers
New York, New York, United States, 10065
Actively Recruiting
15
Associated Medical Professionals of NY
Syracuse, New York, United States, 13210
Actively Recruiting
16
The Bronx Veterans Medical Research Foundation, Inc.
The Bronx, New York, United States, 10468
Actively Recruiting
17
Duke Cancer Institute
Durham, North Carolina, United States, 27705
Actively Recruiting
18
Associate Urologist of North Carolina
Raleigh, North Carolina, United States, 27612
Actively Recruiting
19
Oregon Urology Institute
Springfield, Ohio, United States, 97477
Actively Recruiting
20
MidLantic Urology
Bala-Cynwyd, Pennsylvania, United States, 19004
Actively Recruiting
21
Keystone Urology Specialists
Lancaster, Pennsylvania, United States, 17604
Actively Recruiting
22
Carolina Urologic Research Center
Myrtle Beach, South Carolina, United States, 29572
Actively Recruiting
23
Lowcounty Urology Clinics, P.A.
North Charleston, South Carolina, United States, 29406
Actively Recruiting
24
Conrad Pearson-Memphis
Germantown, Tennessee, United States, 38138
Actively Recruiting
25
Urology Associates PC
Nashville, Tennessee, United States, 37209
Actively Recruiting
26
Urology Austin
Austin, Texas, United States, 78759
Actively Recruiting
27
Baylor College of Medicine
Houston, Texas, United States, 77030
Actively Recruiting
28
Urology San Antonio
San Antonio, Texas, United States, 78229
Actively Recruiting
29
Epworth Freemasons-Victoria Parade
Richmond, Victoria, Australia, 3121
Actively Recruiting
30
Istituti Fisioterapici Ospitalieri (IFO)
Rome, Italy, Italy
Actively Recruiting
31
Istituto Europeo di Oncologia
Milan, Italy, 20141
Actively Recruiting
32
Azienda Ospedaliero Universitaria Pisana - Ospedale Santa Chiara
Pisa, Italy, 56126
Actively Recruiting
33
ASL Napoli 2 Nord - Ospedale Santa Maria delle Grazie
Pozzuoli, Italy, 80078
Actively Recruiting
34
Centro Médico Teknon
Barcelona, Spain, Spain, 08003
Actively Recruiting
35
Hospital Clínico San Carlos
Madrid, Spain, Spain, 28040
Active, Not Recruiting
36
Hospital Universitario 12 de Oc
Madrid, Spain, Spain, 28041
Actively Recruiting
37
Hospital Quirón Barcelona
Barcelona, Spain, 08908
Actively Recruiting
38
MD Anderson Cancer Center - Madrid
Madrid, Spain, 28003
Actively Recruiting
39
Hospital Universitario Ramón y Cajal
Madrid, Spain, 28034
Actively Recruiting
40
Hospital Universitario Marqués de Valdecilla
Santander, Spain, 39008
Actively Recruiting
Research Team
G
Grace Indyk
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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