OncoMatch/Clinical Trials/NCT06995677
Efficacy and Safety of TYRA-300 in Participants With FGFR3 Altered Low Grade, Intermediate Risk Non-Muscle Invasive Bladder Cancer
Official title: 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)
Is NCT06995677 recruiting? Yes, currently enrolling (Oct 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 70 mg — Phase 2 Study of TYRA-300 in FGFR3 Altered Low Grade, Intermediate Risk NMIBC
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Urothelial Carcinoma
Biomarker criteria
Required: FGFR3 activating mutation
Documented activating FGFR3 alteration (mutation or fusion)
Required: FGFR3 fusion
Documented activating FGFR3 alteration (mutation or fusion)
Disease stage
Required: Stage TA LOW GRADE, T1 LOW GRADE
Excluded: Stage MUSCLE INVASIVE BLADDER CANCER, LYMPH NODE POSITIVE BLADDER CANCER, METASTATIC BLADDER CANCER
Grade: low-grade
Ta low grade; T1 low grade; low-grade NMIBC
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: FGFR inhibitor
Current or history of receiving a prior FGFR inhibitor
Cannot have received: systemic cancer therapy (cytotoxic, immunotherapy, targeted)
Currently receiving systemic cancer therapy (cytotoxic, immunotherapy, targeted)
Cannot have received: pelvic external beam radiotherapy for bladder cancer
Current or prior history of pelvic external beam radiotherapy for bladder cancer
Lab requirements
Blood counts
ANC ≥ 1,500/mm3; Platelet count ≥ 75,000/mm3; Hemoglobin ≥ 10.0 g/dL
Kidney function
estimated glomerular filtration rate >30 mL/min (MDRD or CKD-EPI formula)
Liver function
Total bilirubin ≤ ULN; ALT ≤ ULN; AST ≤ ULN
Adequate bone marrow, liver, and renal function as defined as: 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: estimated glomerular filtration rate >30 mL/min (MDRD or CKD-EPI formula).
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
- Eisenhower Medical Associates · Rancho Mirage, California
- Om Research LLC · San Diego, California
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 FGFR inhibitor, systemic cancer therapy (cytotoxic, immunotherapy, targeted), pelvic external beam radiotherapy for bladder cancer 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.
What disease stage is eligible?
Stage TA LOW GRADE or T1 LOW GRADE is required.
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 qualifyRelated pages