[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100592470":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":30,"centralContacts":42,"locations":51,"responsibleParty":291,"collaborators":30,"id":293,"slug":294,"hasResults":295,"nctId":296,"briefTitle":297,"officialTitle":298,"acronym":30,"eligibilityCriteria":299,"healthyVolunteers":295,"sex":300,"minAge":301,"maxAge":30,"enrollmentInfo":302,"targetDuration":30,"studyType":305,"phases":306,"briefSummary":309,"conditions":310,"keywords":313,"overallStatus":54,"whyStopped":30,"lastUpdateSubmitDate":344,"lastUpdatePostDateStruct":345,"startDateStruct":348,"completionDateStruct":350,"leadSponsor":352,"locationsCount":353},{"fullName":5,"class":6},"Ensem Therapeutics","INDUSTRY",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Part A Dose Escalation Monotherapy (Advanced Solid Tumors with PIK3CA mutation)","EXPERIMENTAL","Part A is a dose escalation monotherapy of ETX-636 in advanced solid tumors with PIK3CA mutation",[13],"Drug: ETX-636 dose escalation",{"label":15,"type":10,"description":16,"interventionNames":17},"Part B Dose Escalation Combination Therapy (HR+\u002FHER2- locally advanced or metastatic breast cancer)","Part B is a dose escalation combination therapy in HR+\u002FHER2- locally advanced or metastatic breast cancer. The study treatment will be ETX-636, a pan-mutant-selective PI3Kα inhibitor, in combination with fulvestrant (Faslodex) at a fixed dose of 500 mg IM.",[18],"Drug: ETX-636 dose escalation in combination with fulvestrant",{"label":20,"type":10,"description":21,"interventionNames":22},"Part C Dose Expansion Combination Therapy (HR+\u002FHER2- locally advanced or metastatic breast cancer)","Part B is a dose expansion combination therapy in HR+\u002FHER2- locally advanced or metastatic breast cancer. The study treatment will be ETX-636, a pan-mutant-selective PI3Kα inhibitor, in combination with fulvestrant (Faslodex) at a fixed dose of 500 mg IM.",[23],"Drug: ETX-636 dose expansion in combination with fulvestrant",[25,31,37],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"DRUG","ETX-636 dose escalation","ETX-636 is a pan-mutant-selective PI3Kα Inhibitor and degrader in the form of an oral tablet that will be taken once per day in 28-day cycles, to evaluate escalating dose levels.",[9],null,{"type":26,"name":32,"description":33,"armGroupLabels":34,"otherNames":35},"ETX-636 dose escalation in combination with fulvestrant","ETX-636 is a pan-mutant-selective PI3Kα Inhibitor and degrader in the form of an oral tablet. ETX-636 will be taken in combination with fulvestrant in 28-day cycles, to evaluate escalating dose levels. EXT-636 is an oral tablet that will be taken once per day. Fulvestrant will be administered as an injection 2 weeks apart in the first 28 days, followed by monthly injections.",[15],[36],"Faslodex",{"type":26,"name":38,"description":39,"armGroupLabels":40,"otherNames":41},"ETX-636 dose expansion in combination with fulvestrant","ETX-636 is a pan-mutant-selective PI3Kα Inhibitor and degrader in the form of an oral tablet. ETX-636 will be taken in combination with fulvestrant in 28-day cycles, to expand selected dose levels. EXT-636 is an oral tablet that will be taken once per day. Fulvestrant will be administered as an injection 2 weeks apart in the first 28 days, followed by monthly injections.",[20],[36],[43,48],{"name":44,"role":45,"phone":46,"phoneExt":30,"email":47},"Janaki Parameswaran, MD","CONTACT","1-617-383-4993","janaki.parameswaran@Ensemtx.com",{"name":49,"role":45,"phone":46,"phoneExt":30,"email":50},"Melinda Snyder","melinda.snyder-ext@Ensemtx.com",[52,74,90,107,124,135,152,167,183,200,217,234,248,262,276],{"facility":53,"status":54,"city":55,"state":56,"zip":57,"country":58,"countryCode":59,"cosmosGeoPoint":60,"geoPoint":65,"contacts":66},"Hoag Memorial Hospital Presbyterian","RECRUITING","Newport Beach","California","92663","United States","US",{"type":61,"coordinates":62},"Point",[63,64],-117.92895,33.61891,{"lat":64,"lon":63},[67,71],{"name":68,"role":45,"phone":69,"phoneExt":30,"email":70},"Angela J Fuller","949-764-4891","aj.fuller@hoag.org",{"name":72,"role":73,"phone":30,"phoneExt":30,"email":30},"Monica Mita, MD","PRINCIPAL_INVESTIGATOR",{"facility":75,"status":54,"city":76,"state":56,"zip":77,"country":58,"countryCode":59,"cosmosGeoPoint":78,"geoPoint":82,"contacts":83},"UCSF Helen Diller Family Comprehensive Cancer Center","San Francisco","94158",{"type":61,"coordinates":79},[80,81],-122.41942,37.77493,{"lat":81,"lon":80},[84,88],{"name":85,"role":45,"phone":86,"phoneExt":30,"email":87},"Phu Lam","415-818-7994","Phu.Lam@ucsf.edu",{"name":89,"role":73,"phone":30,"phoneExt":30,"email":30},"Varun Monga, MD",{"facility":91,"status":54,"city":92,"state":93,"zip":94,"country":58,"countryCode":59,"cosmosGeoPoint":95,"geoPoint":99,"contacts":100},"Yale University, Yale Cancer Center","New Haven","Connecticut","06520",{"type":61,"coordinates":96},[97,98],-72.92816,41.30815,{"lat":98,"lon":97},[101,105],{"name":102,"role":45,"phone":103,"phoneExt":30,"email":104},"Carl Brown","203-785-4095","carl.brown@yale.edu",{"name":106,"role":73,"phone":30,"phoneExt":30,"email":30},"Adriana Kahn, MD",{"facility":108,"status":54,"city":109,"state":110,"zip":111,"country":58,"countryCode":59,"cosmosGeoPoint":112,"geoPoint":116,"contacts":117},"Beth Israel Deaconess Medical Center","Boston","Massachusetts","02215",{"type":61,"coordinates":113},[114,115],-71.05977,42.35843,{"lat":115,"lon":114},[118,122],{"name":119,"role":45,"phone":120,"phoneExt":30,"email":121},"Susan Gotthardt","617-975-7452","sgotthar@bidmc.harvard.edu",{"name":123,"role":73,"phone":30,"phoneExt":30,"email":30},"Gerburg Wulf, MD",{"facility":125,"status":54,"city":109,"state":110,"zip":111,"country":58,"countryCode":59,"cosmosGeoPoint":126,"geoPoint":128,"contacts":129},"Dana-Farber Cancer Institute",{"type":61,"coordinates":127},[114,115],{"lat":115,"lon":114},[130,133],{"name":131,"role":45,"phone":132,"phoneExt":30,"email":30},"CT.GOV Contact","877-338-7425",{"name":134,"role":73,"phone":30,"phoneExt":30,"email":30},"Sarah Simmons, MD",{"facility":136,"status":54,"city":137,"state":138,"zip":139,"country":58,"countryCode":59,"cosmosGeoPoint":140,"geoPoint":144,"contacts":145},"Carolina BioOncology Institute","Huntersville","North Carolina","28078",{"type":61,"coordinates":141},[142,143],-80.84285,35.41069,{"lat":143,"lon":142},[146,150],{"name":147,"role":45,"phone":148,"phoneExt":30,"email":149},"Hannah Wall","980-441-1148","hwall@carolinabiooncology.org",{"name":151,"role":73,"phone":30,"phoneExt":30,"email":30},"Neel Gandhi, MD",{"facility":153,"status":54,"city":154,"state":155,"zip":156,"country":58,"countryCode":59,"cosmosGeoPoint":157,"geoPoint":161,"contacts":162},"The University of Texas MD Anderson Cancer Center","Houston","Texas","77030",{"type":61,"coordinates":158},[159,160],-95.36327,29.76328,{"lat":160,"lon":159},[163,166],{"name":164,"role":45,"phone":165,"phoneExt":30,"email":30},"Jordi Rodon Ahnert, MD, PhD","713-792-5603",{"name":164,"role":73,"phone":30,"phoneExt":30,"email":30},{"facility":168,"status":54,"city":169,"state":155,"zip":170,"country":58,"countryCode":59,"cosmosGeoPoint":171,"geoPoint":175,"contacts":176},"START","San Antonio","78229",{"type":61,"coordinates":172},[173,174],-98.49363,29.42412,{"lat":174,"lon":173},[177,181],{"name":178,"role":45,"phone":179,"phoneExt":30,"email":180},"Isabel Jimenenz, RN, MSN","210-593-5265","isabel.jimenez@startresearch.com",{"name":182,"role":73,"phone":30,"phoneExt":30,"email":30},"Amita Patnaik, MD, FRPC",{"facility":184,"status":54,"city":185,"state":186,"zip":187,"country":58,"countryCode":59,"cosmosGeoPoint":188,"geoPoint":192,"contacts":193},"NEXT","Fairfax","Virginia","22031",{"type":61,"coordinates":189},[190,191],-77.30637,38.84622,{"lat":191,"lon":190},[194,198],{"name":195,"role":45,"phone":196,"phoneExt":30,"email":197},"Maybelle De La Rosa","703-783-4518","mdelarosa@nextoncology.com",{"name":199,"role":73,"phone":30,"phoneExt":30,"email":30},"Alex Spira, MD, PhD, FACP",{"facility":201,"status":54,"city":202,"state":203,"zip":204,"country":58,"countryCode":59,"cosmosGeoPoint":205,"geoPoint":209,"contacts":210},"Fred Hutchinson Cancer Center","Seattle","Washington","98109",{"type":61,"coordinates":206},[207,208],-122.33207,47.60621,{"lat":208,"lon":207},[211,215],{"name":212,"role":45,"phone":213,"phoneExt":30,"email":214},"Kaysey Hermens","206-667-5715","khermens@fredhutch.org",{"name":216,"role":73,"phone":30,"phoneExt":30,"email":30},"Jennifer M Specht, MD",{"facility":218,"status":54,"city":219,"state":30,"zip":30,"country":220,"countryCode":221,"cosmosGeoPoint":222,"geoPoint":226,"contacts":227},"Beijing Luhe Hospital,Capital Medical University","Beijing","China","CN",{"type":61,"coordinates":223},[224,225],116.39723,39.9075,{"lat":225,"lon":224},[228,232],{"name":229,"role":45,"phone":230,"phoneExt":30,"email":231},"Dong Yan","010-60569362","yd15yt88@163.com",{"name":233,"role":73,"phone":30,"phoneExt":30,"email":30},"Dong Yan, MD",{"facility":235,"status":54,"city":236,"state":30,"zip":30,"country":220,"countryCode":221,"cosmosGeoPoint":237,"geoPoint":241,"contacts":242},"Fujian Cancer Hospital","Fuzhou",{"type":61,"coordinates":238},[239,240],119.30611,26.06139,{"lat":240,"lon":239},[243,247],{"name":244,"role":45,"phone":245,"phoneExt":30,"email":246},"Fan Wu, MD","0591-62002091","104247733@qq.com",{"name":244,"role":73,"phone":30,"phoneExt":30,"email":30},{"facility":249,"status":54,"city":250,"state":30,"zip":30,"country":220,"countryCode":221,"cosmosGeoPoint":251,"geoPoint":255,"contacts":256},"Sun Yat-sen University Cancer Center","Guangzhou",{"type":61,"coordinates":252},[253,254],113.25,23.11667,{"lat":254,"lon":253},[257,261],{"name":258,"role":45,"phone":259,"phoneExt":30,"email":260},"Shusen Wang, MD","020-87343009","wangshs@sysucc.org.cn",{"name":258,"role":73,"phone":30,"phoneExt":30,"email":30},{"facility":263,"status":54,"city":264,"state":30,"zip":30,"country":220,"countryCode":221,"cosmosGeoPoint":265,"geoPoint":269,"contacts":270},"Shandong Cancer Hospital&Institute","Shandong",{"type":61,"coordinates":266},[267,268],120.48412,40.28464,{"lat":268,"lon":267},[271,275],{"name":272,"role":45,"phone":273,"phoneExt":30,"email":274},"Huihui Li, MD","0531-67626929","rxnklihh@163.com",{"name":272,"role":73,"phone":30,"phoneExt":30,"email":30},{"facility":277,"status":54,"city":278,"state":30,"zip":30,"country":220,"countryCode":221,"cosmosGeoPoint":279,"geoPoint":283,"contacts":284},"Fudan University Shanghai Cancer Hospital","Shanghai",{"type":61,"coordinates":280},[281,282],121.45806,31.22222,{"lat":282,"lon":281},[285,289],{"name":286,"role":45,"phone":287,"phoneExt":30,"email":288},"Hongxia Wang","021-34778299","whx365@126.com",{"name":290,"role":73,"phone":30,"phoneExt":30,"email":30},"Hongxia Wang, MD",{"type":292,"investigatorFullName":30,"investigatorTitle":30,"investigatorAffiliation":30,"oldNameTitle":30,"oldOrganization":30},"SPONSOR","100592470","phase-1-phase-12-study-of-etx-636-in-participants-with-advanced-solid-tumors-100592470",false,"NCT06993844","Phase 1\u002F2 Study of ETX-636 in Participants With Advanced Solid Tumors","A Phase 1\u002F2, Open-label, First-in-human Study of the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of ETX-636, a Pan-mutant-selective PI3Kα Inhibitor, as Monotherapy and in Combination With Other Anticancer Therapies in Participants With Advanced Solid Tumors","Key Inclusion Criteria:\n\n* Metastatic or locally advanced and unresectable solid tumor that has progressed on or after at least one available therapy.\n* Tumor harboring an activating PIK3CA mutation detected in either tumor tissue or ctDNA.\n* At least 1 measurable lesion or evaluable disease per RECIST v1.1.\n* An ECOG performance status score of 0 or 1.\n* Adequate organ function.\n\nAdditional key inclusion criterion for Parts B and C:\n\n\\- Confirmed metastatic or locally advanced HR+\u002FHER2- breast cancer not amenable to surgical resection with curative intent and must have received at least 1 prior CDK4\u002F6 inhibitor and at least 1 prior anti-estrogen therapy.\n\nKey Exclusion Criteria:\n\n* Has history (within ≤2 years before screening) of a solid tumor or hematological malignancy that is histologically distinct from the cancers being studied.\n* Has symptomatic brain or spinal metastases or a known or suspected history of untreated or uncontrolled central nervous system (CNS) involvement.\n* Has an established diagnosis of diabetes mellitus type 1 or has uncontrolled diabetes mellitus type 2.\n* Has received treatment with any local or systemic anticancer therapy or investigational anticancer agent within 14 days prior to start of treatment.\n* Has toxicities from previous anticancer therapies that have not resolved to baseline levels with the exception of alopecia and peripheral neuropathy.\n* Has had radiotherapy outside the target tumor lesions within 14 days prior to start of treatment.","ALL","18 Years",{"count":303,"type":304},233,"ESTIMATED","INTERVENTIONAL",[307,308],"PHASE1","PHASE2","Phase 1\u002F2, open-label study of ETX-636 in participants with advanced solid tumors",[311,312],"Advanced Solid Tumors","Advanced Breast Cancer",[314,315,316,317,318,319,320,321,322,323,324,325,326,327,328,329,330,331,332,333,334,335,336,337,338,339,340,341,342,343],"cancer","breast cancer","solid tumors","PIK3CA","PI3Kα inhibitor","Breast Neoplasms","Neoplasms by Site","Neoplasms","Breast Diseases","HER2-negative breast cancer","HR-positive breast cancer","Gynecologic cancer","Endometrial cancer","Ovarian cancer","Cervical cancer","Head and neck cancer","Head and neck squamous cell carcinoma","Fulvestrant","Antineoplastic Agents","PI3Kα","PI3K alpha","PI3Kα mutation","Alpelisib","Estrogen Receptor Antagonists","Estrogen Antagonists","Hormone Receptor Antagonists","Hormone Antagonists","Hormones, Hormone Substitutes, and Hormone Antagonists","Physiological Effects of Drugs","PIK3CA mutation","2026-06-21",{"date":346,"type":347},"2026-06-23","ACTUAL",{"date":349,"type":347},"2025-06-10",{"date":351,"type":304},"2027-12-30",{"name":5,"class":6},15]