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TYRA-300 for FGFR3‑altered low‑grade, intermediate‑risk non‑muscle invasive bladder cancer

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)

Phase 2 Interventional Tyra Biosciences, Inc · NCT06995677

This trial tests whether the oral drug TYRA-300 can help people with low‑grade, intermediate‑risk non‑muscle invasive bladder cancer that has FGFR3 changes.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment90 (estimated)
Ages18 Years and up
SexAll
SponsorTyra Biosciences, Inc Industry-sponsored
Drugs / interventionschemotherapy, immunotherapy
Locations38 sites (Homewood, Alabama and 37 other locations)
Trial IDNCT06995677 on ClinicalTrials.gov

What this trial studies

This is a Phase 2, multicenter, open‑label trial of TYRA‑300 in adults with histologically confirmed low‑grade Ta or T1 non‑muscle invasive bladder cancer harboring activating FGFR3 mutations or fusions. Participants must have a small residual visible marker lesion after biopsy or TURBT and will receive one of several TYRA‑300 dose regimens (including 60 mg and 50 mg arms) to measure response and safety. The study will monitor tumor response at the marker lesion, recurrence rates, and adverse events across treatment cohorts. Results will inform whether TYRA‑300 has sufficient activity and tolerability to pursue larger trials in this population.

Who should consider this trial

Good fit: Adults (18+) with histologically confirmed low‑grade Ta or T1 non‑muscle invasive bladder cancer at intermediate risk who have an activating FGFR3 mutation or fusion and a small residual marker lesion after resection are the intended candidates.

Not a fit: Patients without activating FGFR3 alterations, those with high‑grade or muscle‑invasive disease, or those unable to attend site visits or tolerate the drug are unlikely to benefit from this study.

Why it matters

Potential benefit: If successful, TYRA‑300 could shrink or eliminate marker bladder tumors and reduce recurrence, offering a targeted oral treatment option for patients with FGFR3‑altered low‑grade NMIBC.

How similar studies have performed: Oral FGFR inhibitors have produced responses in FGFR‑altered advanced urothelial carcinoma, but targeted FGFR therapy in non‑muscle invasive disease remains less well studied.

Eligibility criteria

Show full inclusion / exclusion criteria 
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

Where this trial is running

Homewood, Alabama and 37 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Low-grade NMIBCFGFR Gene AmplificationFGFR Gene AlterationsFGFR3 Gene AlterationFGFR3 Gene MutationFGFR3 Gene FusionsFGFR3 gene alterationsFGFR3 gene mutations
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.