[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100586467":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":29,"centralContacts":33,"locations":39,"responsibleParty":182,"collaborators":28,"id":184,"slug":185,"hasResults":186,"nctId":187,"briefTitle":188,"officialTitle":189,"acronym":190,"eligibilityCriteria":191,"healthyVolunteers":186,"sex":192,"minAge":193,"maxAge":28,"enrollmentInfo":194,"targetDuration":28,"studyType":197,"phases":198,"briefSummary":200,"conditions":201,"keywords":216,"overallStatus":42,"whyStopped":28,"lastUpdateSubmitDate":230,"lastUpdatePostDateStruct":231,"startDateStruct":234,"completionDateStruct":236,"leadSponsor":238,"locationsCount":239},{"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",[40,54,63,72,82,92,102,112,121,131,143,152,157,162,167,177],{"facility":41,"status":42,"city":43,"state":44,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":28},"USC Norris Comprehensive Cancer Center","RECRUITING","Los Angeles","California","90033","United States","US",{"type":49,"coordinates":50},"Point",[51,52],-118.24368,34.05223,{"lat":52,"lon":51},{"facility":55,"status":42,"city":56,"state":44,"zip":57,"country":46,"countryCode":47,"cosmosGeoPoint":58,"geoPoint":62,"contacts":28},"UCSF Medical Center at Mount Zion","San Francisco","94158",{"type":49,"coordinates":59},[60,61],-122.41942,37.77493,{"lat":61,"lon":60},{"facility":64,"status":42,"city":65,"state":44,"zip":66,"country":46,"countryCode":47,"cosmosGeoPoint":67,"geoPoint":71,"contacts":28},"Stanford Cancer Institute","Stanford","94305",{"type":49,"coordinates":68},[69,70],-122.16608,37.42411,{"lat":70,"lon":69},{"facility":73,"status":42,"city":74,"state":75,"zip":76,"country":46,"countryCode":47,"cosmosGeoPoint":77,"geoPoint":81,"contacts":28},"The University of Kansas Medical 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2C4","Canada","CA",{"type":49,"coordinates":139},[140,141],-79.39864,43.70643,{"lat":141,"lon":140},{"facility":144,"status":42,"city":145,"state":28,"zip":28,"country":146,"countryCode":28,"cosmosGeoPoint":147,"geoPoint":151,"contacts":28},"Asan Medical Center","Seoul","South Korea",{"type":49,"coordinates":148},[149,150],126.9784,37.566,{"lat":150,"lon":149},{"facility":153,"status":42,"city":145,"state":28,"zip":28,"country":146,"countryCode":28,"cosmosGeoPoint":154,"geoPoint":156,"contacts":28},"Samsung Medical Center",{"type":49,"coordinates":155},[149,150],{"lat":150,"lon":149},{"facility":158,"status":42,"city":145,"state":28,"zip":28,"country":146,"countryCode":28,"cosmosGeoPoint":159,"geoPoint":161,"contacts":28},"Seoul National University Hospital",{"type":49,"coordinates":160},[149,150],{"lat":150,"lon":149},{"facility":163,"status":42,"city":145,"state":28,"zip":28,"country":146,"countryCode":28,"cosmosGeoPoint":164,"geoPoint":166,"contacts":28},"Severance Hospital, Yonsei University Health System",{"type":49,"coordinates":165},[149,150],{"lat":150,"lon":149},{"facility":168,"status":42,"city":169,"state":28,"zip":28,"country":170,"countryCode":171,"cosmosGeoPoint":172,"geoPoint":176,"contacts":28},"National Taiwan University Hospital","Taipei","Taiwan","TW",{"type":49,"coordinates":173},[174,175],121.52639,25.05306,{"lat":175,"lon":174},{"facility":178,"status":42,"city":169,"state":28,"zip":28,"country":170,"countryCode":171,"cosmosGeoPoint":179,"geoPoint":181,"contacts":28},"Taipei Veterans General Hospital",{"type":49,"coordinates":180},[174,175],{"lat":175,"lon":174},{"type":183,"investigatorFullName":28,"investigatorTitle":28,"investigatorAffiliation":28,"oldNameTitle":28,"oldOrganization":28},"SPONSOR","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",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":195,"type":196},100,"ESTIMATED","INTERVENTIONAL",[199],"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.",[202,203,204,205,206,207,208,209,210,211,212,213,214,215],"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",[217,218,219,220,221,222,223,224,225,226,227,228,229],"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":232,"type":233},"2025-11-20","ACTUAL",{"date":235,"type":233},"2025-04-24",{"date":237,"type":196},"2028-09",{"name":5,"class":6},16]