[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"hr-her2--breast-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:hr-her2--breast-cancer":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,75],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":74},"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":19,"type":20},32,"ESTIMATED","INTERVENTIONAL",[23,24],"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.",[27],"HR+ HER2- Breast Cancer",[29,30,31,32,33,34,35,36,37,38,39,40,41,42,43,44,45,46,47,48,49,50,51,52,53,54,55,56,57,58,59,60,61],"Serabelisib","Sapanisertib","Fulvestrant","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","RECRUITING","2026-06-30",{"date":65,"type":66},"2026-07-02","ACTUAL",{"date":68,"type":66},"2026-04-22",{"date":70,"type":20},"2033-05",{"name":72,"class":73},"Faeth Therapeutics","INDUSTRY",7,{"id":76,"slug":77,"hasResults":11,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":4,"eligibilityCriteria":81,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":82,"targetDuration":4,"studyType":21,"phases":84,"briefSummary":85,"conditions":86,"keywords":90,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":114},"100595203","phase-1-a-study-with-nkt5097-for-adults-with-advancedmetastatic-solid-tumors-100595203","NCT07029399","A Study With NKT5097 for Adults With Advanced\u002FMetastatic Solid Tumors","A Phase 1, First-in-Human, Open-Label Study to Evaluate the Safety, Tolerability, PK, and Preliminary Anti-tumor Activity of the Novel Oral Selective CDK2\u002FCDK4 Dual Degrader NKT5097 in Adults With Advanced\u002FMetastatic Solid Tumors","Inclusion Criteria:\n\n* Able to provide written informed consent\n* Advanced unresectable or metastatic solid tumor (Part 1, 2 \\& 3 only)\n* Advanced unresectable or metastatic HR+\u002FHER2- breast cancer (Part 4 \\& 5 only)\n* Refractory to or unable to tolerate existing therapies (Part 1, 2 \\& 4 only)\n* Measurable or evaluable disease (Part 1, 2, \\& 4 only).\n* Measurable disease (Part 3 \\& 5 only)\n* Eighteen years of age or older\n* ECOG status of 0 or 1\n* Adequate organ function\n* Patients with female reproductive organs must be surgically sterile, post- menopausal or willing to use effective contraception per protocol\n* Patients who are capable of insemination must be willing to use highly effective contraception and to refrain from sperm donation during treatment and for 28 days after the last dose\n* Able to swallow oral meds\n* Willing to provide tumor tissue\n\nExclusion Criteria:\n\n* Advanced solid tumor that is a candidate for curative treatment\n* History of another malignancy except for the following: adequately treated local basal cell or squamous carcinoma of the skin, in situ cervical cancer, adequately treated papillary noninvasive bladder cancer, other adequately treated Stage I or Stage II cancers currently in complete remission\n* Not recovered from the effects of prior anticancer therapy\n* Clinically significant cardiovascular event, including myocardial infarction, arterial thromboembolism, or cerebrovascular thromboembolism, within 6 months\n* Known active CNS metastases and\u002For carcinomatous meningitis\n* Active interstitial lung disease requiring treatment\n* History of uveitis, retinopathy, or other clinically significant retinal disease\n* Major surgery within 30 days of administration of first dose\n* Active uncontrolled infectious disease\n* Significant liver disease (Child Pugh class B or C)\n* Should not have received any prior selective investigational inhibitors or degraders (Part 5 only)",{"count":83,"type":20},361,[23],"The goal of this open-label dose escalation and expansion study is to evaluate the safety and tolerability of NKT5097 in adults with advanced\u002Fmetastatic tumors (emphasis on breast cancer and solid tumors with CCNE1 amplification). Main questions to answer include:\n\n* What is the recommended dose for expansion and\u002For Phase 2, for both monotherapy and in combination with ET\n* What medical issues\u002Fsymptoms do participants experience when taking NKT5097 as monotherapy as well as in combination with ET",[87,88,89,27],"HR+ Breast Cancer","Triple Negative Breast Cancer (TNBC)","CCNE1 Amplified Advanced Solid Tumors",[91,92,93,94,95,43,96,97,98,31,99,100,101,102,103,104],"CCNE1","cyclin E1","triple negative breast cancer","TNBC","estrogen receptor positive","breast cancer","post CDK4\u002F6i","HER2 expression","Letrozole","endocrine therapy","refractory","endocrine resistant","endocrine sensitivity","metastatic","2026-06-25",{"date":107,"type":66},"2026-06-26",{"date":109,"type":66},"2025-03-25",{"date":111,"type":20},"2027-12-31",{"name":113,"class":73},"NiKang Therapeutics, Inc.",18]