[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"fgfr3-gene-alteration\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:fgfr3-gene-alteration":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,52],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":33,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":40,"lastUpdatePostDateStruct":41,"startDateStruct":44,"completionDateStruct":46,"leadSponsor":48,"locationsCount":51},"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":20,"type":21},90,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","Phase 2 Study of TYRA-300 in FGFR3 Altered Low Grade, Intermediate Risk NMIBC",[27,28,29,30,31,32],"Low-grade NMIBC","FGFR Gene Amplification","FGFR Gene Alterations","FGFR3 Gene Alteration","FGFR3 Gene Mutation","FGFR3 Gene Fusions",[34,35,36,37,38],"FGFR3 gene alterations","FGFR3 gene mutations","FGFR3 gene fusions","FGFR3","Non-Muscle Invasive Bladder Cancer","RECRUITING","2026-06-26",{"date":42,"type":43},"2026-06-29","ACTUAL",{"date":45,"type":43},"2025-06-27",{"date":47,"type":21},"2028-09",{"name":49,"class":50},"Tyra Biosciences, Inc","INDUSTRY",45,{"id":53,"slug":54,"hasResults":11,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":58,"eligibilityCriteria":59,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":60,"targetDuration":4,"studyType":22,"phases":62,"briefSummary":64,"conditions":65,"keywords":75,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":92,"locationsCount":93},"100586467","phase-1-safety-and-preliminary-anti-tumor-activity-of-tyra-430-in-advanced-hepatocellular-carcinoma-and-other-solid-tumors-with-activating-fgffgfr-pathway-aberrations-100586467","NCT06915753","Safety and Preliminary Anti-Tumor Activity of TYRA-430 in Advanced Hepatocellular Carcinoma and Other Solid Tumors With Activating FGF\u002FFGFR Pathway Aberrations","A Multicenter, Open-label, First-in-Human Study of TYRA-430 in Advanced Hepatocellular Carcinoma and Other Solid Tumors With Activating FGF\u002FFGFR Pathway Aberrations","SURF431","Key Inclusion Criteria:\n\nAll Patients:\n\n* Age ≥ 18 years\n* Eastern Cooperative Oncology Group (ECOG) performance status of ≤1.\n* Adequate end organ function.\n* Ability to swallow oral formulations.\n* Ability to understand and willingness to sign the ICF.\n\nPart A:\n\n* Histologically confirmed locally advanced unresectable\u002Fmetastatic HCC or histologically confirmed advanced solid tumor with documented FGF\u002FFGFR pathway alterations\n* For participants with histologically confirmed locally advanced or metastatic HCC:\n\n  * Barcelona Clinic Liver Cancer (BCLC) stage B that is not eligible for locoregional therapy, or stage C.\n  * Child-Pugh Score class A\n* Must have previously received SOC appropriate for their tumor type. Any number of prior therapies, including FGFR inhibitors, are permitted.\n* Agree to provide archival tumor tissue no older than 2 years from the time of enrollment, if available. If an archived specimen is not available, a biopsy is not required.\n\nPart B, Cohort 1:\n\n* Histologically confirmed locally advanced\u002Fmetastatic HCC who have previously received standard of care.\n* Barcelona Clinic Liver Cancer (BCLC) stage B that is not eligible for locoregional therapy, or stage C.\n* Child-Pugh Score class A\n* Availability of an archival formalin-fixed paraffin-embedded (FFPE) tumor tissue specimen obtained ≤2 years prior to screening for submission to sponsor-designated central laboratory for FGF19 IHC testing.\n* At least 1 measurable lesion by RECIST v1.1.\n\nPart B, Cohort 2:\n\n* Histologically confirmed advanced solid tumor except FGFR3-altered urothelial carcinoma and primary central nervous system tumors who have previously received standard of care. Note: Participants with confirmed diagnosis of locally advanced or metastatic HCC are not eligible for Cohort 2.\n* Must have an eligible activating gain-of-function alteration in the FGFR3 or FGFR4 gene, or focal amplifications of FGF19\n* Archival tumor tissue biopsy specimen no older than 2 years from the time of enrollment, if available. If a tissue biopsy specimen is not available, a biopsy is not required.\n* At least 1 measurable lesion by RECIST v1.1.\n\nKey Exclusion Criteria:\n\nAll Patients:\n\n* Have disease that is suitable for local therapy administered with curative intent.\n* Have not recovered from reversible toxicity of prior anticancer therapy to \\\u003C Grade 1 or baseline (except toxicities that are not clinically significant or not expected to resolve, including but not limited to, alopecia, fatigue, skin discoloration, or Grade 1 neuropathy).\n* Have received the following anticancer therapy:\n\n  1. Any immunotherapy or other antibody therapy within 28 days prior to the first dose of the study drug.\n  2. A TKI \\\u003C 5 days or 5X the terminal Phase elimination half-lives, whichever is longer, prior to the first dose of TYRA-430.\n  3. Other systemic therapy not listed above \\\u003C 14 days prior to the first dose of the study drug.\n* Participant discontinued a prior anti-FGFR therapy due to significant toxicity, defined as hepatotoxicity ≥ Grade 3 or any Grade 4 toxicity according to CTCAE v5.0.\n* Has a serum phosphorus level \\> upper limit of normal (ULN) during screening that remains \\>ULN despite medical management.\n* History of or current uncontrolled cardiovascular disease.\n* Active, symptomatic, or untreated brain metastases.\n* Have a diagnosis of primary CNS malignancies.\n* Gastrointestinal disorders that will affect oral administration or absorption of TYRA-430.\n* Females who are pregnant, breastfeeding, or planning to become pregnant and males who plan to father a child while enrolled in this study.\n* Any reason that, in the view of investigator, would substantially impair the ability of the participant to comply with study procedures and increase the risk to the participant.\n\nPart B, Cohort 1:\n\n* Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC.\n* Prior treatment with pan-FGFR inhibitors or FGFR4-selective inhibitors.\n\nPart B, Cohort 2:\n\n* Histologically confirmed locally advanced\u002Fmetastatic HCC.\n* Histologically confirmed urothelial cancer.",{"count":61,"type":21},100,[63],"PHASE1","A Phase 1 study to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamic (PD), and preliminary antitumor activity of TYRA-430 in cancers with FGF\u002FFGFR pathway aberrations, including locally advanced\u002Fmetastatic hepatocellular carcinoma and other advanced solid tumors.",[66,67,68,28,29,30,31,69,70,71,72,73,32,74],"Metastatic Hepatocellular Carcinoma","Solid Tumors","Solid Tumor, Adult","Advanced Solid Tumors","FGFR4 Gene Mutation","FGFR4 Gene Fusions","FGF19 Gene Amplification","FGF19 Gene Overexpression","Locally Advanced Unresectable Hepatocellular Carcinoma",[76,77,78,79,80,34,81,82,83,35,36,84,85],"Hepatocellular Carcinoma","metastatic cancer","solid tumors","FGF19 gene amplifications","FGFR4 gene alterations","FGF19 gene alterations","FGFR4 gene mutations","FGFR4 gene fusions","FGF19 gene overexpression","locally advanced unresectable cancer","2025-11-18",{"date":88,"type":43},"2025-11-20",{"date":90,"type":43},"2025-04-24",{"date":47,"type":21},{"name":49,"class":50},16]