[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"ccne1-amplified-advanced-solid-tumors\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:ccne1-amplified-advanced-solid-tumors":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"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":24,"conditions":25,"keywords":30,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":48,"lastUpdatePostDateStruct":49,"startDateStruct":52,"completionDateStruct":54,"leadSponsor":56,"locationsCount":59},"100595203","phase-1-a-study-with-nkt5097-for-adults-with-advancedmetastatic-solid-tumors-100595203",false,"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)","ALL","18 Years",{"count":19,"type":20},361,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","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",[26,27,28,29],"HR+ Breast Cancer","Triple Negative Breast Cancer (TNBC)","CCNE1 Amplified Advanced Solid Tumors","HR+ HER2- Breast Cancer",[31,32,33,34,35,36,37,38,39,40,41,42,43,44,45,46],"CCNE1","cyclin E1","triple negative breast cancer","TNBC","estrogen receptor positive","HER2-","breast cancer","post CDK4\u002F6i","HER2 expression","Fulvestrant","Letrozole","endocrine therapy","refractory","endocrine resistant","endocrine sensitivity","metastatic","RECRUITING","2026-06-25",{"date":50,"type":51},"2026-06-26","ACTUAL",{"date":53,"type":51},"2025-03-25",{"date":55,"type":20},"2027-12-31",{"name":57,"class":58},"NiKang Therapeutics, Inc.","INDUSTRY",18]