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Valdecilla","Santander","39008",{"type":58,"coordinates":461},[462,463],-3.80493,43.46589,{"lat":463,"lon":462},{"type":466,"investigatorFullName":29,"investigatorTitle":29,"investigatorAffiliation":29,"oldNameTitle":29,"oldOrganization":29},"SPONSOR","100592611","phase-2-efficacy-and-safety-of-tyra-300-in-participants-with-fgfr3-altered-low-grade-intermediate-risk-non-muscle-invasive-bladder-cancer-100592611",false,"NCT06995677","Efficacy and Safety of TYRA-300 in Participants With 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)","SURF302","Inclusion Criteria:\n\n* Participants age 18 and over of informed consent and willing and able to comply with all requires study procedures\n* Able to understand and given written informed consent\n* Participants with histologically confirmed low-grade NMIBC within 6 weeks prior to randomization with prior diagnostic biopsy\u002FTURBT to confirm stage and grade and with at least 3 mm and no more than 12 mm total (1\u002F2 a resectoscope loop to 2 loops, refer to Section 8.1.5) residual visible tumor as a marker lesion(s) left behind:\n\n  1. Ta low grade\n  2. T1 low grade\n* Participants must have intermediate risk NMIBC, defined as having any of the following characteristics (AUA Guidelines, 2024)\n\n  1. Recurrence within 1 year, LG Ta\n  2. Solitary LG Ta \\>3cm\n  3. LG Ta, multifocal\n  4. LG T1\n* Documented activating FGFR3 mutation or fusion (Appendix 4)\n* Have undergone bladder mapping and identification of visible marker lesion(s) within 6 weeks prior to randomization (refer to Inclusion Criterion #3)\n* No evidence of urothelial carcinoma of the upper urinary tract (confirmed by imaging) or prostatic urethra within 6 months of randomization\n* No prior BCG administration within 1 year of date of consent.\n* No intravesical chemotherapy within 8 weeks prior to C1D1.\n* ECOG 0-1\n* Pathology consistent with pure urothelial carcinoma; if mixed histology, ensure that at least 80% of the sample is urothelial\n* Adequate bone marrow, liver, and renal function:\n\n  b. Bone marrow function: i. Absolute neutrophil count (ANC) \\> or = 1,500\u002Fmm3 ii. Platelet count \\> or = 75,000\u002Fmm3 iii. \u002Fhemoglobin \\> or = 10.0 g\u002FdL e. Liver function: i.Total bilirubin \\\u003C or = ULN ii. Alanine aminotransferase (ALT) \\\u003C or = ULN iii. Aspartate aminotransferase (AST) \\\u003C or = ULN f. Renal function: i. estimated glomerular filtration rate \\>60 mL\u002Fmin calculated using the modification of diet in renal disease equation or CKD-EPI formula ii. Serum Phosphate level \\\u003C or = ULN prior to starting treatment g. Coagulation i. International normalized ratio (INR) \\\u003C or = 1.5 x ULN\n* Ability to swallow tablets\n* 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.\n* 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.\n* Potential participants with chronic hepatitis B virus (HBV) infection with active disease should be on a suppressive antiviral therapy prior to C1D1.\n* 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.\n* Potential participants with a history of HCV infection and on current treatment must have a HCV viral load below the limit of quantification\n\nExclusion Criteria:\n\n* Presence of tumor in ureter or prostatic urethra:\n* Current or previous history of muscle invasive bladder cancer\n* Current or previous history of lymph node positive and\u002For metastatic bladder cancer\n* Evidence of pure squamous cell carcinoma, pure adenocarcinoma or pure undifferentiated carcinoma of the bladder\n* Currently receiving systemic cancer therapy (cytotoxic, immunotherapy, targeted)\n* Currently receiving treatment with a prohibited therapy (refer to Section 6.7.1)\n* Current or prior history of pelvic external beam radiotherapy\n* Current or history of receiving a prior FGFR inhibitor\n* Systemic immunotherapy within 6 months prior to randomization\n* 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.\n* Prior treatment with an intravesical agent within 8 weeks prior to C1D1\n* Current ongoing toxicity from previous therapy\n* Had major surgery within 4 weeks prior to C1D1\n* Any reason that in the view of the investigator, would substantially impair the ability of the participant to comply with study procedures and\u002For risk to the participant (i.e., uncontrolled diabetes)\n* 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\n* Has impaired wound healing capacity\n* Serum phosphate levels above the upper limit of normal during screening\n* Any ocular condition likely to increase the risk of eye toxicity\n* Current evidence of central serous retinopathy or retinal pigmented epithelial detachment of any grade at time of baseline examination.\n* History of or current uncontrolled cardiovascular disease\n* Gastrointestinal disorders that will affect oral administration or absorption of TYRA-300\n* Known history of HIV infection, or active hepatitis B or C\n* 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) .\n* Known allergy to TYRA-300 or any excipients of the formulated product\n* Participants taking strong inhibitors and\u002For inducers of CYP3A4 enzyme\n* History of prolonged QT syndrome or baseline heart rate-corrected QT interval using Fridericia formula (QTcF) interval \\>470 ms","ALL","18 Years",{"count":478,"type":479},90,"ESTIMATED","INTERVENTIONAL",[482],"PHASE2","Phase 2 Study of TYRA-300 in FGFR3 Altered Low Grade, Intermediate Risk NMIBC",[485,486,487,488,489,490],"Low-grade NMIBC","FGFR Gene Amplification","FGFR Gene Alterations","FGFR3 Gene Alteration","FGFR3 Gene Mutation","FGFR3 Gene Fusions",[492,493,494,495,496],"FGFR3 gene alterations","FGFR3 gene mutations","FGFR3 gene fusions","FGFR3","Non-Muscle Invasive Bladder Cancer","2026-06-26",{"date":499,"type":500},"2026-06-29","ACTUAL",{"date":502,"type":500},"2025-06-27",{"date":504,"type":479},"2028-09",{"name":5,"class":6},45]