Phase 2 TYRA-300 for FGFR3-Altered Bladder Cancer
This study is looking at how well and how safely an oral tablet called TYRA-300 works for people with a specific type of bladder cancer. This is low-grade, intermediate-risk non-muscle invasive bladder cancer (NMIBC) that has changes in the FGFR3 gene. You might take a 50mg or 60mg dose of TYRA-300 daily, or a dose that will be decided later. The main goal is to see how effective TYRA-300 is after 3 months. To join, you must be at least 18 years old and have this specific type of bladder cancer confirmed by a doctor. The current recruitment status is unclear.
- Study design
- This is a Phase 2, open-label study, meaning you and your doctors will know which dose of TYRA-300 you are receiving. It plans to enroll about 90 participants.
- What's involved
- You would take an oral tablet of TYRA-300 daily. You would also need to be able to understand and sign an informed consent form.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary effectiveness of the treatment will be assessed at 3 months.
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NCT06995677
Efficacy and Safety of TYRA-300 in Participants With FGFR3 Altered Low Grade, Intermediate Risk Non-Muscle Invasive Bladder Cancer
Recruiting
PHASE2Ages 18+InterventionalTreatmentTyra Biosciences, Inc
~90 participants
Updated 2026-08-06 on ClinicalTrials.gov
What's tested:TYRA-300 60mgTYRA-300 50mgTYRA-300 Dose TBD
At a glance
Recruiting sites
46 of 47 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
To assess the efficacy of TYRA-300 in LG IR-NMIBC participants
Measured over at 3 months
Conditions
Where it's being run
47 sites across 20 statesSpain7
New York5
Texas4
Italy4
California3
South Carolina3
Illinois2
Indiana2
Study leadership
- Doug Warner, MD · STUDY_CHAIR · Tyra Biosciences, Inc
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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:
Participants must have intermediate risk NMIBC, defined as having any of the following characteristics (AUA Guidelines, 2024)
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:
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
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
What this trial measures
- To assess the efficacy of TYRA-300 in LG IR-NMIBC participantsat 3 months
Complete response (CR) rate