[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100586467":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":29,"centralContacts":33,"locations":39,"responsibleParty":179,"collaborators":28,"id":181,"slug":28,"hasResults":182,"nctId":183,"briefTitle":184,"officialTitle":185,"acronym":186,"eligibilityCriteria":187,"healthyVolunteers":182,"sex":188,"minAge":189,"maxAge":28,"enrollmentInfo":190,"targetDuration":28,"studyType":193,"phases":194,"briefSummary":196,"conditions":197,"keywords":212,"overallStatus":42,"whyStopped":28,"lastUpdateSubmitDate":226,"lastUpdatePostDateStruct":227,"startDateStruct":230,"completionDateStruct":232,"leadSponsor":234,"locationsCount":235},{"fullName":5,"class":6},"Tyra Biosciences, Inc","INDUSTRY",[8,14,18],{"label":9,"type":10,"description":11,"interventionNames":12},"Part A - Dose Escalation","EXPERIMENTAL","Dose escalation of TYRA-430 as monotherapy at various dose levels.",[13],"Drug: TYRA-430",{"label":15,"type":10,"description":16,"interventionNames":17},"Part B - Cohort 1 Dose Expansion","Dose expansion group for TYRA-430 monotherapy in advanced HCC at a dose(s) determined in Part A.",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"Part B - Cohort 2 Dose Expansion","Dose expansion group for TYRA-430 monotherapy in advanced solid tumors at a dose(s) determined in Part A.",[13],[23],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"DRUG","TYRA-430","Oral TYRA-430 given daily.",[9,15,19],null,[30],{"name":31,"affiliation":5,"role":32},"Doug Warner, MD","STUDY_CHAIR",[34],{"name":35,"role":36,"phone":37,"phoneExt":28,"email":38},"Grace Indyk","CONTACT","858-356-2323","TyraClinicalTrials@tyra.bio",[40,53,62,71,81,91,101,111,120,130,141,150,155,160,165,174],{"facility":41,"status":42,"city":43,"state":44,"zip":45,"country":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":28},"USC Norris Comprehensive Cancer Center","RECRUITING","Los Angeles","California","90033","United States",{"type":48,"coordinates":49},"Point",[50,51],-118.24368,34.05223,{"lat":51,"lon":50},{"facility":54,"status":42,"city":55,"state":44,"zip":56,"country":46,"cosmosGeoPoint":57,"geoPoint":61,"contacts":28},"UCSF Medical Center at Mount Zion","San Francisco","94158",{"type":48,"coordinates":58},[59,60],-122.41942,37.77493,{"lat":60,"lon":59},{"facility":63,"status":42,"city":64,"state":44,"zip":65,"country":46,"cosmosGeoPoint":66,"geoPoint":70,"contacts":28},"Stanford Cancer Institute","Stanford","94305",{"type":48,"coordinates":67},[68,69],-122.16608,37.42411,{"lat":69,"lon":68},{"facility":72,"status":42,"city":73,"state":74,"zip":75,"country":46,"cosmosGeoPoint":76,"geoPoint":80,"contacts":28},"The University of Kansas Medical Center","Westwood","Kansas","66205",{"type":48,"coordinates":77},[78,79],-94.6169,39.04056,{"lat":79,"lon":78},{"facility":82,"status":42,"city":83,"state":84,"zip":85,"country":46,"cosmosGeoPoint":86,"geoPoint":90,"contacts":28},"John Hopkins University","Baltimore","Maryland","21205",{"type":48,"coordinates":87},[88,89],-76.61219,39.29038,{"lat":89,"lon":88},{"facility":92,"status":42,"city":93,"state":94,"zip":95,"country":46,"cosmosGeoPoint":96,"geoPoint":100,"contacts":28},"Mass General Cancer Center","Boston","Massachusetts","02114",{"type":48,"coordinates":97},[98,99],-71.05977,42.35843,{"lat":99,"lon":98},{"facility":102,"status":42,"city":103,"state":104,"zip":105,"country":46,"cosmosGeoPoint":106,"geoPoint":110,"contacts":28},"Karmanos Cancer Institute","Detroit","Michigan","48201",{"type":48,"coordinates":107},[108,109],-83.04575,42.33143,{"lat":109,"lon":108},{"facility":112,"status":42,"city":113,"state":113,"zip":114,"country":46,"cosmosGeoPoint":115,"geoPoint":119,"contacts":28},"Columbia University Irving Medical Center","New York","10043",{"type":48,"coordinates":116},[117,118],-74.00597,40.71427,{"lat":118,"lon":117},{"facility":121,"status":42,"city":122,"state":123,"zip":124,"country":46,"cosmosGeoPoint":125,"geoPoint":129,"contacts":28},"Sarah Cannon Research Institute Oncology Partners","Nashville","Tennessee","37203",{"type":48,"coordinates":126},[127,128],-86.78444,36.16589,{"lat":128,"lon":127},{"facility":131,"status":42,"city":132,"state":133,"zip":134,"country":135,"cosmosGeoPoint":136,"geoPoint":140,"contacts":28},"University Health Network Princess Margaret Cancer Center","Toronto","Ontario","M5G 2C4","Canada",{"type":48,"coordinates":137},[138,139],-79.39864,43.70643,{"lat":139,"lon":138},{"facility":142,"status":42,"city":143,"state":28,"zip":28,"country":144,"cosmosGeoPoint":145,"geoPoint":149,"contacts":28},"Asan Medical Center","Seoul","South Korea",{"type":48,"coordinates":146},[147,148],126.9784,37.566,{"lat":148,"lon":147},{"facility":151,"status":42,"city":143,"state":28,"zip":28,"country":144,"cosmosGeoPoint":152,"geoPoint":154,"contacts":28},"Samsung Medical Center",{"type":48,"coordinates":153},[147,148],{"lat":148,"lon":147},{"facility":156,"status":42,"city":143,"state":28,"zip":28,"country":144,"cosmosGeoPoint":157,"geoPoint":159,"contacts":28},"Seoul National University Hospital",{"type":48,"coordinates":158},[147,148],{"lat":148,"lon":147},{"facility":161,"status":42,"city":143,"state":28,"zip":28,"country":144,"cosmosGeoPoint":162,"geoPoint":164,"contacts":28},"Severance Hospital, Yonsei University Health System",{"type":48,"coordinates":163},[147,148],{"lat":148,"lon":147},{"facility":166,"status":42,"city":167,"state":28,"zip":28,"country":168,"cosmosGeoPoint":169,"geoPoint":173,"contacts":28},"National Taiwan University Hospital","Taipei","Taiwan",{"type":48,"coordinates":170},[171,172],121.52639,25.05306,{"lat":172,"lon":171},{"facility":175,"status":42,"city":167,"state":28,"zip":28,"country":168,"cosmosGeoPoint":176,"geoPoint":178,"contacts":28},"Taipei Veterans General Hospital",{"type":48,"coordinates":177},[171,172],{"lat":172,"lon":171},{"type":180,"investigatorFullName":28,"investigatorTitle":28,"investigatorAffiliation":28,"oldNameTitle":28,"oldOrganization":28},"SPONSOR","100586467",false,"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.","ALL","18 Years",{"count":191,"type":192},100,"ESTIMATED","INTERVENTIONAL",[195],"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.",[198,199,200,201,202,203,204,205,206,207,208,209,210,211],"Metastatic Hepatocellular Carcinoma","Solid Tumors","Solid Tumor, Adult","FGFR Gene Amplification","FGFR Gene Alterations","FGFR3 Gene Alteration","FGFR3 Gene Mutation","Advanced Solid Tumors","FGFR4 Gene Mutation","FGFR4 Gene Fusions","FGF19 Gene Amplification","FGF19 Gene Overexpression","FGFR3 Gene Fusions","Locally Advanced Unresectable Hepatocellular Carcinoma",[213,214,215,216,217,218,219,220,221,222,223,224,225],"Hepatocellular Carcinoma","metastatic cancer","solid tumors","FGF19 gene amplifications","FGFR4 gene alterations","FGFR3 gene alterations","FGF19 gene alterations","FGFR4 gene mutations","FGFR4 gene fusions","FGFR3 gene mutations","FGFR3 gene fusions","FGF19 gene overexpression","locally advanced unresectable cancer","2025-11-18",{"date":228,"type":229},"2025-11-20","ACTUAL",{"date":231,"type":229},"2025-04-24",{"date":233,"type":192},"2028-09",{"name":5,"class":6},16]