OncoMatch/Clinical Trials/NCT06995677
Efficacy and Safety of TYRA-300 in Participants With FGFR3 Altered Low Grade, Intermediate Risk Non-Muscle Invasive Bladder Cancer
Is NCT06995677 recruiting? Yes, currently enrolling (Jun 2026). This Phase 2 trial studies multiple treatments including TYRA-300 60mg and TYRA-300 50mg for low-grade nmibc.
Treatment: TYRA-300 60mg · TYRA-300 50mg · TYRA-300 Dose TBD — Phase 2 Study of TYRA-300 in FGFR3 Altered Low Grade, Intermediate Risk NMIBC
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Biomarker criteria
Required: FGFR3 activating mutation
Required: FGFR3 fusion
Disease stage
Grade: low
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: BCG
Exception: BCG within 1 year of date of consent
No prior BCG administration within 1 year of date of consent.
Cannot have received: intravesical chemotherapy
Exception: within 8 weeks prior to C1D1
No intravesical chemotherapy within 8 weeks prior to C1D1.
Cannot have received: FGFR inhibitor
Current or history of receiving a prior FGFR inhibitor
Cannot have received: systemic immunotherapy
Exception: within 6 months prior to randomization
Systemic immunotherapy within 6 months prior to randomization
Cannot have received: systemic cancer therapy
Currently receiving systemic cancer therapy (cytotoxic, immunotherapy, targeted)
Cannot have received: pelvic external beam radiotherapy
Current or prior history of pelvic external beam radiotherapy
Cannot have received: investigational agent
Exception: within 30 days or 5 half-lives from randomization, whichever is shorter
Treatment with an investigational agent within 30 days or 5 half-lives from randomization, whichever is shorter
Cannot have received: intravesical agent
Exception: within 8 weeks prior to C1D1
Prior treatment with an intravesical agent within 8 weeks prior to C1D1
Lab requirements
Blood counts
ANC ≥ 1,500/mm3; Platelet count ≥ 75,000/mm3; Hemoglobin ≥ 10.0 g/dL
Kidney function
eGFR >60 mL/min (MDRD or CKD-EPI); Serum Phosphate ≤ ULN prior to starting treatment
Liver function
Total bilirubin ≤ ULN; ALT ≤ ULN; AST ≤ ULN
Adequate bone marrow, liver, and renal function: Bone marrow function: ANC ≥ 1,500/mm3; Platelet count ≥ 75,000/mm3; Hemoglobin ≥ 10.0 g/dL; Liver function: Total bilirubin ≤ ULN; ALT ≤ ULN; AST ≤ ULN; Renal function: eGFR >60 mL/min (MDRD or CKD-EPI); Serum Phosphate ≤ ULN prior to starting treatment
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Urology Centers of Alabama · Homewood, Alabama
- Arkansas Urology · Little Rock, Arkansas
- Tri Valley Urology - Murrieta · Murrieta, California
- Om Research LLC · San Diego, California
- Associated Urological Specialists · Chicago Ridge, Illinois
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT06995677 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior BCG, intravesical chemotherapy, FGFR inhibitor disqualifies patients from enrollment.
Does this trial require FGFR3?
Yes, FGFR3 activating mutation is a required biomarker for enrollment.
Does this trial require FGFR3?
Yes, FGFR3 fusion is a required biomarker for enrollment.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify