RecruitingLow-grade NMIBCFGFR Gene AmplificationFGFR Gene Alterations

Efficacy and Safety of TYRA-300 in Participants With FGFR3 Altered Low Grade, Intermediate Risk Non-Muscle Invasive Bladder Cancer

Eligible age

18+ yrs

Accepts

All genders

Locations

16 states

Healthy volunteers

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Phase 2 Study of TYRA-300 in FGFR3 Altered Low Grade, Intermediate Risk NMIBC

Sponsor: Tyra Biosciences, Inc

✓ 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

✕ 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