[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100635903":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":35,"locations":41,"responsibleParty":111,"collaborators":26,"id":113,"slug":114,"hasResults":115,"nctId":116,"briefTitle":117,"officialTitle":118,"acronym":26,"eligibilityCriteria":119,"healthyVolunteers":115,"sex":120,"minAge":121,"maxAge":26,"enrollmentInfo":122,"targetDuration":26,"studyType":125,"phases":126,"briefSummary":129,"conditions":130,"keywords":132,"overallStatus":44,"whyStopped":26,"lastUpdateSubmitDate":163,"lastUpdatePostDateStruct":164,"startDateStruct":167,"completionDateStruct":169,"leadSponsor":171,"locationsCount":172},{"fullName":5,"class":6},"Faeth Therapeutics","INDUSTRY",[8,16],{"label":9,"type":10,"description":11,"interventionNames":12},"Cohort A1 - Sapanisertib and serabelisib (PIKTOR) with fulvestrant","EXPERIMENTAL","Subjects will receive doses of sapanisertib and serabelisib (PIKTOR) administered orally and fulvestrant administered intramuscularly.",[13,14,15],"Drug: Serabelisib","Drug: Sapanisertib","Drug: Fulvestrant",{"label":17,"type":10,"description":18,"interventionNames":19},"Cohort A2 - Sapanisertib and serabelisib (PIKTOR) with fulvestrant","Subjects will receive doses of sapanisertib and serabelisib (PIKTOR) at a higher dose than Cohort A1 administered orally and fulvestrant administered intramuscularly.",[13,14,15],[21,27,31],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Serabelisib","Serabelisib is a selective, small molecule inhibitor of PI3Kα.",[9,17],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Sapanisertib","Sapanisertib is a small molecule inhibitor of the mammalian mTOR serine\u002Fthreonine kinase.",[9,17],{"type":22,"name":32,"description":33,"armGroupLabels":34,"otherNames":26},"Fulvestrant","Fulvestrant is a first-in-class SERD.",[9,17],[36],{"name":37,"role":38,"phone":39,"phoneExt":26,"email":40},"Medical Monitor","CONTACT","(708) 406-9282","clinicaltrials@faeththerapeutics.com",[42,56,66,76,86,96,105],{"facility":43,"status":44,"city":45,"state":46,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":26},"START Los Angeles","RECRUITING","Los Angeles","California","90025","United States","US",{"type":51,"coordinates":52},"Point",[53,54],-118.24368,34.05223,{"lat":54,"lon":53},{"facility":57,"status":44,"city":58,"state":59,"zip":60,"country":48,"countryCode":49,"cosmosGeoPoint":61,"geoPoint":65,"contacts":26},"Rocky Mountain Cancer Centers","Lone Tree","Colorado","80124",{"type":51,"coordinates":62},[63,64],-104.8863,39.55171,{"lat":64,"lon":63},{"facility":67,"status":44,"city":68,"state":69,"zip":70,"country":48,"countryCode":49,"cosmosGeoPoint":71,"geoPoint":75,"contacts":26},"Oncology Associates of Oregon","Springfield","Oregon","97477",{"type":51,"coordinates":72},[73,74],-123.02203,44.04624,{"lat":74,"lon":73},{"facility":77,"status":44,"city":78,"state":79,"zip":80,"country":48,"countryCode":49,"cosmosGeoPoint":81,"geoPoint":85,"contacts":26},"SCRI Oncology Partners","Nashville","Tennessee","37203",{"type":51,"coordinates":82},[83,84],-86.78444,36.16589,{"lat":84,"lon":83},{"facility":87,"status":44,"city":88,"state":89,"zip":90,"country":48,"countryCode":49,"cosmosGeoPoint":91,"geoPoint":95,"contacts":26},"Texas Oncology - Central\u002FSouth","Austin","Texas","78731",{"type":51,"coordinates":92},[93,94],-97.74306,30.26715,{"lat":94,"lon":93},{"facility":97,"status":44,"city":98,"state":89,"zip":99,"country":48,"countryCode":49,"cosmosGeoPoint":100,"geoPoint":104,"contacts":26},"START San Antonio","San Antonio","78229",{"type":51,"coordinates":101},[102,103],-98.49363,29.42412,{"lat":103,"lon":102},{"facility":106,"status":44,"city":98,"state":89,"zip":107,"country":48,"countryCode":49,"cosmosGeoPoint":108,"geoPoint":110,"contacts":26},"Texas Oncology - San Aantonio","78240",{"type":51,"coordinates":109},[102,103],{"lat":103,"lon":102},{"type":112,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100635903","phase-1-sapanisertib-and-serabelisib-piktor-in-various-combinations-in-patients-with-hrher2--advancedmetastatic-breast-cancer-100635903",false,"NCT07558733","Sapanisertib and Serabelisib (PIKTOR) in Various Combinations in Patients With HR+\u002FHER2- Advanced\u002FMetastatic Breast Cancer","Open-Label Umbrella Study to Evaluate Safety and Efficacy of Sapanisertib and Serabelisib (PIKTOR) in Various Combinations in Patients With HR+\u002FHER2- Advanced or Metastatic Breast Cancer","Inclusion Criteria:\n\n* Histologically confirmed diagnosis of HR+\u002FHER2- breast cancer.\n* Documented evidence of advanced or recurrent disease that is not amenable to surgery\u002Fradiation for curative intent.\n* Participant has received at least one prior systemic therapy.\n* At least 1 measurable or evaluable target lesion according to RECIST v1.1\n* Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1 at Screening.\n* Non-pregnant, non-lactating females who are postmenopausal, surgically sterile or who agree to use effective contraceptive methods.\n\nExclusion Criteria:\n\n* Participants with triple-negative breast cancer.\n* Participants with central nervous system metastases are not eligible, unless they have completed local therapy and have discontinued the use of corticosteroids for this indication for at least 4 weeks before starting treatment in this study.\n* Active malignancy (except for breast cancer, definitively treated in-situ carcinomas \\[e.g., breast, cervix, bladder\\], or basal or squamous cell carcinoma of the skin) within the past 24 months prior to treatment. Fully resected localized malignancies are eligible.\n* Gastric feeding tube (gastrostomy tube), gastrointestinal malabsorption, gastrointestinal anastomosis, bowel obstruction, or any other condition that might affect the absorption of study treatment.\n* Significant cardiovascular impairment.\n* Active, uncontrolled infection.\n* Concurrent participation in another therapeutic clinical trial.\n* Prior radiation therapy within 21 days prior to start of study treatment.\n* Participants who have received a prior PI3K, AKT, mTORC1\u002F2, or dual PI3K\u002FmTOR inhibitor.\n* Strong CYP3A4 inhibitors, strong CYP1A2 inhibitors or CYP1A2 inducers, or clinically significant CYP3A4 inducers within 7 days before the first dose of study intervention, or participants who require treatment with strong CYP3A4 inhibitors or inducers during the study.\n* Prolongation of QTc interval to \\>480 ms.\n* Type 1 or Type 2 diabetes mellitus on insulin.","ALL","18 Years",{"count":123,"type":124},32,"ESTIMATED","INTERVENTIONAL",[127,128],"PHASE1","PHASE2","The study is a Phase 1b\u002F2, multi-center, open-label, dose escalation trial evaluating the safety and preliminary efficacy of sapanisertib and serabelisib (PIKTOR) with fulvestrant and\u002For other anticancer therapies in participants with HR+\u002FHER2- advanced\u002Fmetastatic breast cancer.",[131],"HR+ HER2- Breast Cancer",[23,28,32,133,134,135,136,137,138,139,140,141,142,143,144,145,146,147,148,149,150,151,152,153,154,155,156,157,158,159,160,161,162],"Palbociclib","PI3K","mTOR","Dual PI3K\u002FmTOR inhibition","Genetic Mutation","Faslodex","SERDs","Select Estrogen Receptor Degraders","CDK","CDK46","CDK4-6","HER2-","HER2 negative","HR+","HR positive","Hormone Receptor Positive","Advanced Breast Cancer","Metastatic Breast Cancer","Recurrent Breast Cancer","Breast Cancer","Cancer of the breast","Carcinoma of the breast","Neoplasms, Breast","Metabolism","Synthetic Lethality","Metabolism Programming","PIK3CA","Oral Medications","Antineoplastic agents","AKT","2026-06-30",{"date":165,"type":166},"2026-07-02","ACTUAL",{"date":168,"type":166},"2026-04-22",{"date":170,"type":124},"2033-05",{"name":5,"class":6},7]