[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100528436":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":25,"centralContacts":29,"locations":35,"responsibleParty":92,"collaborators":21,"id":94,"slug":95,"hasResults":96,"nctId":97,"briefTitle":98,"officialTitle":99,"acronym":100,"eligibilityCriteria":101,"healthyVolunteers":96,"sex":102,"minAge":103,"maxAge":21,"enrollmentInfo":104,"targetDuration":21,"studyType":107,"phases":108,"briefSummary":110,"conditions":111,"keywords":116,"overallStatus":38,"whyStopped":21,"lastUpdateSubmitDate":133,"lastUpdatePostDateStruct":134,"startDateStruct":137,"completionDateStruct":139,"leadSponsor":141,"locationsCount":142},{"fullName":5,"class":6},"Tyra Biosciences, Inc","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Phase 1 Part A and Part B","EXPERIMENTAL","TYRA-200 taken once daily by mouth in 28-day cycles",[13,14],"Drug: Phase 1 Part A - dose escalation TYRA-200 taken once daily by mouth in 28-day cycles","Drug: Phase 1 Part B - dose expansion TYRA-200 taken once daily by mouth in 28-day cycles",[16,22],{"type":17,"name":18,"description":19,"armGroupLabels":20,"otherNames":21},"DRUG","Phase 1 Part A - dose escalation TYRA-200 taken once daily by mouth in 28-day cycles","TYRA-200 is an oral, novel potent FGFR 1\u002F2\u002F3 tyrosine kinase inhibitor that targets tumors that contain activating gene alterations of FGFR2.",[9],null,{"type":17,"name":23,"description":19,"armGroupLabels":24,"otherNames":21},"Phase 1 Part B - dose expansion TYRA-200 taken once daily by mouth in 28-day cycles",[9],[26],{"name":27,"affiliation":5,"role":28},"Doug Warner","STUDY_CHAIR",[30],{"name":31,"role":32,"phone":33,"phoneExt":21,"email":34},"Grace Indyk","CONTACT","(619)728-4805","TyraClinicalTrials@tyra.bio",[36,54,68,78],{"facility":37,"status":38,"city":39,"state":40,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"University of California San Francisco (UCSF)","RECRUITING","San Francisco","California","94143","United States","US",{"type":45,"coordinates":46},"Point",[47,48],-122.41942,37.77493,{"lat":48,"lon":47},[51],{"name":52,"role":32,"phone":53,"phoneExt":21,"email":21},"Quincy Harris","415-502-3310",{"facility":55,"status":38,"city":56,"state":57,"zip":58,"country":42,"countryCode":43,"cosmosGeoPoint":59,"geoPoint":63,"contacts":64},"Massachusetts General Hospital","Boston","Massachusetts","02114",{"type":45,"coordinates":60},[61,62],-71.05977,42.35843,{"lat":62,"lon":61},[65],{"name":66,"role":32,"phone":67,"phoneExt":21,"email":21},"Haley Ellis, MD","617-724-4000",{"facility":69,"status":38,"city":70,"state":71,"zip":72,"country":42,"countryCode":43,"cosmosGeoPoint":73,"geoPoint":77,"contacts":21},"The Ohio State University","Columbus","Ohio","43210",{"type":45,"coordinates":74},[75,76],-82.99879,39.96118,{"lat":76,"lon":75},{"facility":79,"status":38,"city":80,"state":81,"zip":82,"country":42,"countryCode":43,"cosmosGeoPoint":83,"geoPoint":87,"contacts":88},"The University of Texas MD Anderson Cancer Center","Houston","Texas","77030",{"type":45,"coordinates":84},[85,86],-95.36327,29.76328,{"lat":86,"lon":85},[89],{"name":90,"role":32,"phone":91,"phoneExt":21,"email":21},"Jodi Rodon Ahnert, MD","713-792-5603",{"type":93,"investigatorFullName":21,"investigatorTitle":21,"investigatorAffiliation":21,"oldNameTitle":21,"oldOrganization":21},"SPONSOR","100528436","phase-1-safety-and-anti-tumor-activity-of-tyra-200-in-advanced-cholangiocarcinoma-with-activating-fgfr2-gene-alterations-100528436",false,"NCT06160752","Safety and Anti-Tumor Activity of TYRA-200 in Advanced Cholangiocarcinoma With Activating FGFR2 Gene Alterations","A Multicenter, Open-label, First-in-Human Study of TYRA-200 in Advanced Intrahepatic Cholangiocarcinoma and Other Solid Tumors With Activating FGFR2 Gene Alterations (SURF-201)","SURF201","Inclusion Criteria:\n\nPhase 1 Part A\n\n* Men and women 18 years of age or older.\n* Eastern Cooperative Oncology Group (ECOG) performance status of ≤1.\n* Any histologically confirmed advanced solid tumor with FGFR\u002FFGF pathway alterations including FGFR gene mutations, fusions, and amplifications, as well as gene amplifications of FGFR ligands, who have exhausted or refused approved standard therapies.\n* Evaluable disease according to RECIST v1.1.\n\nPhase 1 Part B\n\n* Men and women 18 years of age or older.\n* Eastern Cooperative Oncology Group (ECOG) performance status of ≤1.\n* Histologically confirmed locally advanced\u002Fmetastatic intrahepatic cholangiocarcinoma with a previously identified FGFR2 gene mutation or rearrangement.\n* Must have received a prior FGFR inhibitor. Participants may have received more than 1 prior FGFR inhibitor.\n* Presence of an FGFR2 kinase domain mutation that confers resistance to previous\u002Fother FGFR inhibitors; resistance mutations should be identified by a US Food and Drug Administration authorized\u002Fapproved companion diagnostic or a Clinical Laboratory Improvement Amendments (CLIA) validated local test performed in a certified laboratory.\n* At least 1 measurable lesion by RECIST v1.1.\n\nExclusion Criteria:\n\n* 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* Any ocular condition likely to increase the risk of eye toxicity.\n* History of or current uncontrolled cardiovascular disease.\n* Active, symptomatic, or untreated brain metastases.\n* Gastrointestinal disorders that will affect oral administration or absorption of TYRA-200.\n* Females who are pregnant, breastfeeding, or planning to become pregnant and males who plan to father a child while enrolled in this study.","ALL","18 Years",{"count":105,"type":106},40,"ESTIMATED","INTERVENTIONAL",[109],"PHASE1","The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary antitumor activity of TYRA-200 in cancers with FGFR2 activating gene alterations, including unresectable locally advanced\u002Fmetastatic intrahepatic cholangiocarcinoma and other advanced solid tumors.",[112,113,114,115],"Locally Advanced Cholangiocarcinoma","Intrahepatic Cholangiocarcinoma","Solid Tumor","Metastatic Cholangiocarcinoma",[117,118,119,120,121,122,123,124,125,126,127,128,129,130,131,132],"FGFR2 gene activation","FGFR2 gene alterations","FGFR2 gene fusion\u002Frearrangement","FGFR2 gene mutation","FGFR2 gene translocation","FGFR2","Fibroblast growth factor receptor 2 (FGFR2)","Fibroblast growth factor receptor 2 alterations","locally advanced cancer","metastatic cancer","solid tumors","cholangiocarcinoma","intrahepatic cholangiocarcinoma","unresectable cholangiocarcinoma","metastatic cholangiocarcinoma","fibroblast growth factor receptor inhibitor","2024-10-01",{"date":135,"type":136},"2024-10-03","ACTUAL",{"date":138,"type":136},"2023-11-22",{"date":140,"type":106},"2027-09",{"name":5,"class":6},4]