NCT06995677 · Tyra Biosciences, Inc
Efficacy and Safety of TYRA-300 in Participants With FGFR3 Altered Low Grade, Intermediate Risk Non-Muscle Invasive Bladder Cancer
(SURF302)
What this study is about
Phase 2 Study of TYRA-300 in FGFR3 Altered Low Grade, Intermediate Risk NMIBC
View original scientific description
Phase 2 Study of TYRA-300 in FGFR3 Altered Low Grade, Intermediate Risk NMIBC
Interventions
DRUG
TYRA-300 60mg
Self-administered 60mg dose Oral tablet(s) given daily
DRUG
TYRA-300 50mg
Self-administered 50mg dose Oral tablet(s) given daily
DRUG
TYRA-300 Dose TBD
To Be Determined Dose: Self-administered Oral tablet(s) given daily
Primary outcome measures
To assess the efficacy of TYRA-300 in LG IR-NMIBC participants
Time frame: at 3 months
Complete response (CR) rate
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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 #
Where
- Homewood, Alabama
- Little Rock, Arkansas
- Murrieta, California
- Rancho Mirage, California
- San Diego, California
- Chicago Ridge, Illinois
- Lisle, Illinois
- Greenwood, Indiana
- Jeffersonville, Indiana
- Kansas City, Kansas
- Baltimore, Maryland
- Plymouth, Massachusetts
And 20 more locations — see the full list below.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 29, 2026 · Source of record for eligibility and locations