[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100564176":3},{"organization":4,"armGroups":7,"interventions":35,"overallOfficials":40,"centralContacts":61,"locations":67,"responsibleParty":427,"collaborators":40,"id":429,"slug":40,"hasResults":430,"nctId":431,"briefTitle":432,"officialTitle":433,"acronym":40,"eligibilityCriteria":434,"healthyVolunteers":430,"sex":435,"minAge":436,"maxAge":40,"enrollmentInfo":437,"targetDuration":40,"studyType":440,"phases":441,"briefSummary":443,"conditions":444,"keywords":456,"overallStatus":70,"whyStopped":40,"lastUpdateSubmitDate":473,"lastUpdatePostDateStruct":474,"startDateStruct":477,"completionDateStruct":479,"leadSponsor":481,"locationsCount":482},{"fullName":5,"class":6},"TheRas, Inc., d\u002Fb\u002Fa BBOT (BridgeBio Oncology Therapeutics)","INDUSTRY",[8,14,19,25,29],{"label":9,"type":10,"description":11,"interventionNames":12},"BBO-10203","EXPERIMENTAL","Participants enrolled in this cohort will receive BBO-10203 tablets orally (different dose levels will be evaluated) once daily as monotherapy. This cohort will enroll patients with HER2-positive advanced breast cancer, HR-positive HER2-negative advanced breast cancer, advanced colorectal cancer, and advanced lung cancer.",[13],"Drug: BBO-10203",{"label":15,"type":10,"description":16,"interventionNames":17},"BBO-10203 + Trastuzumab","Participants enrolled in this cohort will receive BBO-10203 tablets orally in combination with trastuzumab. This cohort will enroll patients with HER2-positive advanced breast cancer.",[13,18],"Drug: Trastuzumab",{"label":20,"type":10,"description":21,"interventionNames":22},"BBO-10203 + Fulvestrant","Participants enrolled in this cohort will receive BBO-10203 tablets orally in combination with fulvestrant. This cohort will enroll patients with HR-positive, HER2-negative advanced breast cancer.",[13,23,24],"Drug: Fulvestrant","Drug: Ribociclib",{"label":26,"type":10,"description":27,"interventionNames":28},"BBO10203 + Fulvestrant + Ribociclib","Participants enrolled in this cohort will receive BBO-10203 tablets orally in combination with fulvestrant and ribociclib as determined in the dose escalation. This cohort will enroll patients with HR-positive, HER2-negative advanced breast cancer.",[13,23,24],{"label":30,"type":10,"description":31,"interventionNames":32},"BBO10203 + FOLFOX + Bevacizumab","Participants enrolled in this cohort will receive BBO-10203 tablets orally in combination with FOLFOX and bevacizumab. This cohort will enroll patients with KRAS-mutant advanced colorectal cancer.",[13,33,34],"Drug: FOLFOX","Drug: Bevacizumab",[36,41,45,49,53,57],{"type":37,"name":9,"description":38,"armGroupLabels":39,"otherNames":40},"DRUG","Participants will receive assigned dose of BBO-10203 orally once daily",[9,20,15,30,26],null,{"type":37,"name":42,"description":43,"armGroupLabels":44,"otherNames":40},"Trastuzumab","Participants will receive trastuzumab as infusion or subcutaneous injection every 21 days",[15],{"type":37,"name":46,"description":47,"armGroupLabels":48,"otherNames":40},"Fulvestrant","Patients will receive Fulvestrant as an intramuscular injection every 28 days (additional dose on C1D15)",[20,26],{"type":37,"name":50,"description":51,"armGroupLabels":52,"otherNames":40},"Ribociclib","Patients will receive Ribociclib orally once a day (21 days on treatment, 7 days off)",[20,26],{"type":37,"name":54,"description":55,"armGroupLabels":56,"otherNames":40},"FOLFOX","Patients will receive FOLFOX as infusion every 14 days",[30],{"type":37,"name":58,"description":59,"armGroupLabels":60,"otherNames":40},"Bevacizumab","Patients will receive bevacizumab as infusion every 28 days",[30],[62],{"name":63,"role":64,"phone":65,"phoneExt":40,"email":66},"BBOT (BridgeBio Oncology Therapeutics)","CONTACT","650-405-8440","Breaker-101ct.gov@bridgebiooncology.com",[68,81,90,99,108,118,128,138,144,154,163,172,178,188,198,204,213,222,232,242,253,263,274,280,289,298,309,319,329,338,347,357,368,377,386,392,397,406,412,418],{"facility":69,"status":70,"city":71,"state":72,"zip":73,"country":74,"cosmosGeoPoint":75,"geoPoint":80,"contacts":40},"City of Hope Comprehensive Cancer Center","RECRUITING","Duarte","California","91010","United States",{"type":76,"coordinates":77},"Point",[78,79],-117.97729,34.13945,{"lat":79,"lon":78},{"facility":82,"status":70,"city":83,"state":72,"zip":84,"country":74,"cosmosGeoPoint":85,"geoPoint":89,"contacts":40},"University of California Los Angeles","Los Angeles","90095",{"type":76,"coordinates":86},[87,88],-118.24368,34.05223,{"lat":88,"lon":87},{"facility":91,"status":70,"city":92,"state":72,"zip":93,"country":74,"cosmosGeoPoint":94,"geoPoint":98,"contacts":40},"University of California San Diego Moores Cancer Center","San Diego","92093",{"type":76,"coordinates":95},[96,97],-117.16472,32.71571,{"lat":97,"lon":96},{"facility":100,"status":70,"city":101,"state":72,"zip":102,"country":74,"cosmosGeoPoint":103,"geoPoint":107,"contacts":40},"UCSF Helen Diller Family Comprehensive Cancer Center","San Francisco","94158",{"type":76,"coordinates":104},[105,106],-122.41942,37.77493,{"lat":106,"lon":105},{"facility":109,"status":70,"city":110,"state":111,"zip":112,"country":74,"cosmosGeoPoint":113,"geoPoint":117,"contacts":40},"Moffitt Cancer Center","Tampa","Florida","33612",{"type":76,"coordinates":114},[115,116],-82.45843,27.94752,{"lat":116,"lon":115},{"facility":119,"status":70,"city":120,"state":121,"zip":122,"country":74,"cosmosGeoPoint":123,"geoPoint":127,"contacts":40},"Indiana University Simon Comprehensive Cancer Center","Indianapolis","Indiana","46202",{"type":76,"coordinates":124},[125,126],-86.15804,39.76838,{"lat":126,"lon":125},{"facility":129,"status":70,"city":130,"state":131,"zip":132,"country":74,"cosmosGeoPoint":133,"geoPoint":137,"contacts":40},"Massachusetts General Hospital","Boston","Massachusetts","02114",{"type":76,"coordinates":134},[135,136],-71.05977,42.35843,{"lat":136,"lon":135},{"facility":139,"status":70,"city":130,"state":131,"zip":140,"country":74,"cosmosGeoPoint":141,"geoPoint":143,"contacts":40},"Dana-Farber Cancer Insitute","02215",{"type":76,"coordinates":142},[135,136],{"lat":136,"lon":135},{"facility":145,"status":70,"city":146,"state":147,"zip":148,"country":74,"cosmosGeoPoint":149,"geoPoint":153,"contacts":40},"St. Lukes Hospital of Kansas City","Kansas City","Missouri","64111",{"type":76,"coordinates":150},[151,152],-94.57857,39.09973,{"lat":152,"lon":151},{"facility":155,"status":70,"city":156,"state":147,"zip":157,"country":74,"cosmosGeoPoint":158,"geoPoint":162,"contacts":40},"Washington University School of Medicine","St Louis","63110",{"type":76,"coordinates":159},[160,161],-90.19789,38.62727,{"lat":161,"lon":160},{"facility":164,"status":70,"city":165,"state":165,"zip":166,"country":74,"cosmosGeoPoint":167,"geoPoint":171,"contacts":40},"Columbia University Irving Medical Center","New York","10032",{"type":76,"coordinates":168},[169,170],-74.00597,40.71427,{"lat":170,"lon":169},{"facility":173,"status":70,"city":165,"state":165,"zip":174,"country":74,"cosmosGeoPoint":175,"geoPoint":177,"contacts":40},"Memorial Sloan Kettering Cancer Center","10065",{"type":76,"coordinates":176},[169,170],{"lat":170,"lon":169},{"facility":179,"status":70,"city":180,"state":181,"zip":182,"country":74,"cosmosGeoPoint":183,"geoPoint":187,"contacts":40},"SCRI Oncology Partners","Nashville","Tennessee","37203",{"type":76,"coordinates":184},[185,186],-86.78444,36.16589,{"lat":186,"lon":185},{"facility":189,"status":70,"city":190,"state":191,"zip":192,"country":74,"cosmosGeoPoint":193,"geoPoint":197,"contacts":40},"SCRI at Mary Crowley","Dallas","Texas","75230",{"type":76,"coordinates":194},[195,196],-96.80667,32.78306,{"lat":196,"lon":195},{"facility":199,"status":70,"city":190,"state":191,"zip":200,"country":74,"cosmosGeoPoint":201,"geoPoint":203,"contacts":40},"University of Texas Southwestern Medical Center","75390",{"type":76,"coordinates":202},[195,196],{"lat":196,"lon":195},{"facility":205,"status":70,"city":206,"state":191,"zip":207,"country":74,"cosmosGeoPoint":208,"geoPoint":212,"contacts":40},"The University of Texas MD Anderson Cancer Center","Houston","77030",{"type":76,"coordinates":209},[210,211],-95.36327,29.76328,{"lat":211,"lon":210},{"facility":214,"status":70,"city":215,"state":191,"zip":216,"country":74,"cosmosGeoPoint":217,"geoPoint":221,"contacts":40},"University of Texas San Antonio (UTSA)","San Antonio","78229",{"type":76,"coordinates":218},[219,220],-98.49363,29.42412,{"lat":220,"lon":219},{"facility":223,"status":70,"city":224,"state":225,"zip":226,"country":74,"cosmosGeoPoint":227,"geoPoint":231,"contacts":40},"Fred Hutchinson Cancer Center","Seattle","Washington","98109",{"type":76,"coordinates":228},[229,230],-122.33207,47.60621,{"lat":230,"lon":229},{"facility":233,"status":70,"city":234,"state":235,"zip":236,"country":74,"cosmosGeoPoint":237,"geoPoint":241,"contacts":40},"Wisconsin Institute for Medical Research","Madison","Wisconsin","53792",{"type":76,"coordinates":238},[239,240],-89.40123,43.07305,{"lat":240,"lon":239},{"facility":243,"status":70,"city":244,"state":245,"zip":246,"country":247,"cosmosGeoPoint":248,"geoPoint":252,"contacts":40},"Scientia Clinical Research","Randwick","New South Wales","2031","Australia",{"type":76,"coordinates":249},[250,251],151.24895,-33.91439,{"lat":251,"lon":250},{"facility":254,"status":70,"city":255,"state":256,"zip":257,"country":247,"cosmosGeoPoint":258,"geoPoint":262,"contacts":40},"Peter MacCallum Cancer Centre","Melbourne","Victoria","3000",{"type":76,"coordinates":259},[260,261],144.96332,-37.814,{"lat":261,"lon":260},{"facility":264,"status":70,"city":265,"state":266,"zip":267,"country":268,"cosmosGeoPoint":269,"geoPoint":273,"contacts":40},"FUTTURA Oncologia","Porto Alegre","Rio Grande do Sul","90470","Brazil",{"type":76,"coordinates":270},[271,272],-51.23019,-30.03283,{"lat":272,"lon":271},{"facility":275,"status":70,"city":265,"state":266,"zip":276,"country":268,"cosmosGeoPoint":277,"geoPoint":279,"contacts":40},"Hospital São Lucas da PUCRS","90610",{"type":76,"coordinates":278},[271,272],{"lat":272,"lon":271},{"facility":281,"status":70,"city":282,"state":282,"zip":283,"country":268,"cosmosGeoPoint":284,"geoPoint":288,"contacts":40},"Clinica de Pesquisas e Centro de Estudos Em Oncologia Ginecologica e Mamaria Ltda","São Paulo","01317",{"type":76,"coordinates":285},[286,287],-46.63611,-23.5475,{"lat":287,"lon":286},{"facility":290,"status":70,"city":291,"state":282,"zip":292,"country":268,"cosmosGeoPoint":293,"geoPoint":297,"contacts":40},"IEPE - Unimed Sorocaba","Sorocaba","18056",{"type":76,"coordinates":294},[295,296],-47.45806,-23.50167,{"lat":296,"lon":295},{"facility":299,"status":70,"city":300,"state":301,"zip":302,"country":303,"cosmosGeoPoint":304,"geoPoint":308,"contacts":40},"Institut régional du Cancer de Montpellier - Val d'Aurelle","Montpellier","Occitanie","34298","France",{"type":76,"coordinates":305},[306,307],3.87635,43.61093,{"lat":307,"lon":306},{"facility":310,"status":70,"city":311,"state":312,"zip":313,"country":303,"cosmosGeoPoint":314,"geoPoint":318,"contacts":40},"Institut Curie - René-Huguenin Hospital","Saint-Cloud","Paris","92210",{"type":76,"coordinates":315},[316,317],2.20289,48.84598,{"lat":317,"lon":316},{"facility":320,"status":70,"city":321,"state":322,"zip":323,"country":303,"cosmosGeoPoint":324,"geoPoint":328,"contacts":40},"lnstitut de Cancérologie de l'Ouest - Site Saint-Herblain","Saint-Herblain","Pays de la Loire Region","44805",{"type":76,"coordinates":325},[326,327],-1.651,47.21154,{"lat":327,"lon":326},{"facility":330,"status":70,"city":331,"state":40,"zip":332,"country":303,"cosmosGeoPoint":333,"geoPoint":337,"contacts":40},"Institut Bergonie","Bordeaux","33000",{"type":76,"coordinates":334},[335,336],-0.58046,44.84124,{"lat":336,"lon":335},{"facility":339,"status":70,"city":340,"state":40,"zip":341,"country":303,"cosmosGeoPoint":342,"geoPoint":346,"contacts":40},"Centre Léon Bérard","Lyon","69008",{"type":76,"coordinates":343},[344,345],4.84789,45.74906,{"lat":345,"lon":344},{"facility":348,"status":70,"city":349,"state":350,"zip":351,"country":303,"cosmosGeoPoint":352,"geoPoint":356,"contacts":40},"Institut Gustave Roussy","Villejuif","Île-de-France Region","94805",{"type":76,"coordinates":353},[354,355],2.35992,48.7939,{"lat":355,"lon":354},{"facility":358,"status":70,"city":359,"state":360,"zip":361,"country":362,"cosmosGeoPoint":363,"geoPoint":367,"contacts":40},"Hospital Universitario Vall d'Hebron","Barcelona","Catalonia","08035","Spain",{"type":76,"coordinates":364},[365,366],2.15899,41.38879,{"lat":366,"lon":365},{"facility":369,"status":70,"city":370,"state":370,"zip":371,"country":362,"cosmosGeoPoint":372,"geoPoint":376,"contacts":40},"Hospital Beata Maria Ana","Madrid","28007",{"type":76,"coordinates":373},[374,375],-3.70256,40.4165,{"lat":375,"lon":374},{"facility":378,"status":70,"city":379,"state":370,"zip":380,"country":362,"cosmosGeoPoint":381,"geoPoint":385,"contacts":40},"Hospital Quiron Madrid - NEXT Oncology","Pozuelo de Alarcón","28223",{"type":76,"coordinates":382},[383,384],-3.81338,40.43293,{"lat":384,"lon":383},{"facility":387,"status":70,"city":359,"state":40,"zip":388,"country":362,"cosmosGeoPoint":389,"geoPoint":391,"contacts":40},"IOB Institute of Oncology - Hospital Quironsalud Barcelona","08023",{"type":76,"coordinates":390},[365,366],{"lat":366,"lon":365},{"facility":393,"status":70,"city":359,"state":40,"zip":388,"country":362,"cosmosGeoPoint":394,"geoPoint":396,"contacts":40},"START Barcelona - HM Nou Delfos Hospital",{"type":76,"coordinates":395},[365,366],{"lat":366,"lon":365},{"facility":398,"status":70,"city":399,"state":40,"zip":400,"country":362,"cosmosGeoPoint":401,"geoPoint":405,"contacts":40},"Hospital Universitari Arnau de Vilanova","Lleida","25198",{"type":76,"coordinates":402},[403,404],0.62218,41.61674,{"lat":404,"lon":403},{"facility":407,"status":70,"city":370,"state":40,"zip":408,"country":362,"cosmosGeoPoint":409,"geoPoint":411,"contacts":40},"Hospital Universitario Fundación Jiménez Díaz","28040",{"type":76,"coordinates":410},[374,375],{"lat":375,"lon":374},{"facility":413,"status":70,"city":370,"state":40,"zip":414,"country":362,"cosmosGeoPoint":415,"geoPoint":417,"contacts":40},"Hospital Universitario 12 de Octubre","28041",{"type":76,"coordinates":416},[374,375],{"lat":375,"lon":374},{"facility":419,"status":70,"city":420,"state":40,"zip":421,"country":362,"cosmosGeoPoint":422,"geoPoint":426,"contacts":40},"Hospital Universitari i Politècnic La Fe","Valencia","46026",{"type":76,"coordinates":423},[424,425],-0.37966,39.47391,{"lat":425,"lon":424},{"type":428,"investigatorFullName":40,"investigatorTitle":40,"investigatorAffiliation":40,"oldNameTitle":40,"oldOrganization":40},"SPONSOR","100564176",false,"NCT06625775","Open-Label Study of BBO-10203 in Subjects With Advanced Solid Tumors","A Phase 1a\u002F1b Open-Label Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of BBO-10203 in Subjects With Advanced Solid Tumors (The BREAKER-101 Study)","Inclusion Criteria:\n\n* Locally advanced and unresectable or metastatic HER2-positive advanced breast cancer (aBC), HR-positive\u002FHER2-negative advanced breast cancer, KRAS mutant advanced colorectal cancer (aCRC), or KRAS mutant advanced non-small cell lung cancer (aNSCLC)\n* Measurable disease by RECIST v1.1 (except for HR-positive HER2-negative aBC where evaluable bone-only disease is permitted)\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1\n* Adequate LVEF assessed by ECHO or MUGA (BBO-10203 + Trastuzumab cohorts only)\n* Stable brain metastases\n* Patients with HER2-positive aBC: Must have had at least 2 prior lines of anti-HER2-directed therapy. Only 1 prior line is acceptable where there is no other regionally available standard of care (SoC)\n* Monotherapy Cohort patients with HR-positive, HER2-negative aBC, KRAS mutant aCRC or aNSCLC: Must have progression on, or disease recurrence after at least one line of SOC treatment or in the opinion of the investigator, would be unlikely to tolerate or derive clinically meaningful benefit from SoC therapy\n* BBO-10203 + Fulvestrant combination cohort patients with HR-positive, HER2-negative aBC: confirmed PIK3CA mutation, must have been treated with a CDK4\u002F6i\n* BBO-10203 + Fulvestrant + ribociclib combination cohort patients with HR-positive, HER2-negative aBC: confirmed PIK3CA mutation, no prior systemic therapy in the aBC setting permitted\n* BBO-10203 + FOLFOX + Bevacizumab combination cohort patients with KRAS mutant aCRC: One prior line of irinotecan-containing therapy for locally advanced or metastatic CRC is allowed but not required\n\nExclusion Criteria:\n\n* Patients with KRAS mutant aCRC who have KRAS G12R mutation, BRAFV600E mutation, HER2amp, or dMMR\u002FMSI-H tumors\n* Patients with KRAS mutant aNSCLC who have KRAS G12R mutation, or tumors with other targetable driver mutations (eg, EGFR, anaplastic lymphoma kinase, ROS1\u002FBRAF\u002FRET\u002FMET\u002FEGFR exon20 insertion\u002FNTRK\u002FHER2)\n* Patients with untreated and\u002For non-stable brain metastases\n\nOther inclusion\u002Fexclusion criteria are specified in the protocol","ALL","18 Years",{"count":438,"type":439},392,"ESTIMATED","INTERVENTIONAL",[442],"PHASE1","First in human study to evaluate the safety, tolerability, and pharmacokinetics (PK) of BBO-10203, a PI3Kα:RAS breaker, alone and in combination with other anti-cancer agents in patients with advanced solid tumors.",[445,446,447,448,449,450,451,452,453,454,455],"Solid Tumor, Adult","Metastatic Breast Cancer","Advanced Breast Cancer","HER2 Mutation-Related Tumors","HER2-positive Metastatic Breast Cancer","KRAS Mutant Metastatic Colorectal Cancer","Metastatic Lung Cancer","Metastatic Colorectal Cancer","Advanced Lung Cancer","HR-positive, HER2-negative Advanced Breast Cancer","HER2-positive Advanced Breast Cancer",[457,458,459,460,461,42,462,463,464,465,466,467,468,469,470,471,472],"BREAKER-101","BridgeBio Oncology Therapeutics","BBOT","Phase1","Phase 1a\u002F1b","Breast","Colorectal","Non-Small Cell Lung Cancer","CRC","NSCLC","Metastatic Cancer","Advanced Cancer","HER2-positive","HR-positive","HR-positive, HER2-negative","HER2-negative","2026-06-18",{"date":475,"type":476},"2026-06-23","ACTUAL",{"date":478,"type":476},"2024-10-29",{"date":480,"type":439},"2028-11",{"name":5,"class":6},40]