[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"NiKang Therapeutics, Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":116},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,60],{"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,{"id":61,"slug":62,"hasResults":11,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":4,"eligibilityCriteria":66,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":67,"targetDuration":4,"studyType":21,"phases":69,"briefSummary":70,"conditions":71,"keywords":100,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":115},"100561192","phase-1-a-study-with-nkt3964-for-adults-with-advancedmetastatic-solid-tumors-100561192","NCT06586957","A Study With NKT3964 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 CDK2 Degrader NKT3964 in Adults With Advanced\u002FMetastatic Solid Tumors","Inclusion Criteria:\n\n\\- Must have a pathologically confirmed advanced and unresectable or metastatic solid tumor listed below with documented disease progression on last standard treatment. Part 1 only: subjects must be refractory to, or intolerant of existing therapy(ies) known to provide clinical benefit for their condition.\n\nDose Escalation:\n\n1. Ovarian cancer\n2. Endometrial cancer (only endometrioid subtype will require CCNE1 amplification)\n3. Gastric, gastroesophageal junction (GEJ) or esophageal adenocarcinoma with CCNE1 amplification\n4. Small cell lung cancer (SCLC)\n5. Triple-negative breast cancer (TNBC; HER2, estrogen receptor and progesterone receptor negative)\n6. HR+ (includes estrogen-receptor or progesterone-receptor) and HER2- breast cancer (must have progressed following treatment with a CDK4\u002F6 inhibitor, and is not suitable for endocrine therapy \\[ET\\])\n7. Other solid tumors with CCNE1 amplification\n\nDose Expansion:\n\nPart 2A: HR+ and HER2- breast cancer that is locally advanced and unresectable (Stage III) or metastatic (Stage IV); previously treated with ≥1 line of standard of care (SOC) including CDK4\u002F6 inhibitor plus ET and not suitable for further ET. Subjects must have progressed after receiving therapy for ≥3 months in the metastatic setting or for ≥6 months in the adjuvant setting. Subjects must have received ≤2 lines of systemic cytotoxic therapy (chemotherapy or cytotoxic antibody drug conjugate \\[ADC\\]) in the metastatic setting..\n\nPart 2B: Advanced platinum-based-chemotherapy resistant or refractory epithelial ovarian\u002Ffallopian\u002Fprimary peritoneal carcinoma or clear cell ovarian cancer (defined as recurrence ≤6 months after completing platinum-based regimen) with progression on at least one platinum containing therapy and previously treated with ≤4 prior lines of systemic therapy administered for advanced\u002Fmetastatic disease and with CCNE1 amplification.\n\nPart 2C: Advanced unresectable or metastatic gastric, GEJ or esophageal adenocarcinoma with progression on at least one systemic therapy and previously treated with ≤3 prior lines of systemic therapy administered for advanced\u002Fmetastatic disease, with CCNE1 amplification as determined by NGS by local liquid or tissue test.\n\nPart 2D: Advanced endometrial adenocarcinoma or uterine papillary serous carcinoma previously treated with ≤4 prior lines of systemic therapy administered for advanced\u002Fmetastatic disease with CCNE1 amplification.\n\nPart 2E: Advanced\u002Frecurrent uterine carcinosarcoma previously treated with 1 prior platinum-based chemotherapy regimen and ≤3 prior lines of systemic therapy. Prior bevacizumab or PARP inhibitors are allowed and must be at least 3 weeks prior to the start of study drug.\n\n* Have adequate organ function\n* Subjects with female reproductive organs must be surgically sterile, post-menopausal, or must be willing to use highly effective method(s) of contraception\n* Ability to swallow oral medications.\n* Consent to provide archived tumor tissues and paired tumor biopsy at pretreatment\n\nExclusion Criteria:\n\n* Locally advanced solid tumor that is a candidate for curative treatment through radical surgery and\u002For radiotherapy, or chemotherapy.\n* History of another malignancy with exceptions\n* History of lymphohistiocytic or lymphoid hyperplasia; hemophagocytic lymphohistiocytosis.\n* Failed to recover from effects of prior anticancer treatment therapy to baseline or Grade ≤ 1 severity (per CTCAE)\n* Clinically significant cardiovascular event within 6 months prior to start of NKT3964 treatment\n* Known active CNS metastases and\u002For carcinomatous meningitis\n* Active interstitial lung disease currently requiring treatment\n* History of uveitis, retinopathy or other clinically significant retinal disease\n* Active or chronic corneal disorders, other active ocular conditions requiring ongoing therapy, or any clinically significant corneal disease\n* Active wound healing from major surgery within 1 month or minor surgery within 10 days before the first dose of NKT3964.\n* Known human immunodeficiency virus (HIV), active hepatitis B or C infection\n* Prior investigative treatment with a selective or nonselective CDK2 inhibitor or degrader\n* Childs-Pugh class B or C cirrhosis or any other clinically significant liver disorder\n* Palliative radiation therapy within 14 days or other radiation therapy within 4 weeks prior to C1D1",{"count":68,"type":20},150,[23],"The goal of the Dose Escalation phase of the study is to evaluate the safety, tolerability, pharmacokinetics (PK) and preliminary anti-tumor activity to determine the preliminary recommended dose for expansion (RDE) of NKT3964 in adults with advanced or metastatic solid tumors. The goal of the Expansion phase of the study is to evaluate the preliminary anti-tumor activity of NKT3964 at the RDE based on objective response rate (ORR) and determine the preliminary recommended Phase 2 dose (RP2D).",[72,73,74,75,76,77,78,79,80,81,82,83,84,85,86,87,88,89,90,91,92,93,94,95,96,97,98,99],"Solid Tumor","Advanced Solid Tumor","Solid Tumor, Adult","Metastatic Tumor","Ovarian Cancer","Ovarian Neoplasms","Ovarian Carcinoma","Metastatic Ovarian Carcinoma","Endometrial Neoplasms","Endometrial Diseases","Metastatic Endometrial Cancer","Triple Negative Breast Cancer","Metastatic Endometrial Carcinoma","Advanced Endometrial Carcinoma","Advanced Ovarian Carcinoma","Gastric Cancer","Advanced Gastric Carcinoma","Metastatic Gastric Cancer","Metastatic Gastric Carcinoma","Small Cell Lung Cancer","Small Cell Lung Carcinoma","Triple Negative Breast Neoplasms","Platinum-resistant Ovarian Cancer","Platinum-refractory Ovarian Carcinoma","CCNE1 Amplification","Hormone Receptor Negative Breast Carcinoma","Human Epidermal Growth Factor 2 Negative Carcinoma of Breast","Progesterone-receptor-positive Breast Cancer",[101,102,103,104,105,106],"CDK 2 Inhibitor","CDK 4 Inhibitor","CDK 6 Inhibitor","CDK2 Degrader","Protein Degrader","PROTAC","2026-04-16",{"date":109,"type":51},"2026-04-21",{"date":111,"type":51},"2024-09-19",{"date":113,"type":20},"2029-05",{"name":57,"class":58},19,""]