[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"JenKem Technology Co., Ltd.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":88},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,43,65],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100561824","phase-2-jk-1201i-combined-with-adjuvant-temozolomide-in-patients-with-newly-diagnosed-glioblastoma-multiforme-gbm-100561824",false,"NCT06595186","JK-1201I Combined with Adjuvant Temozolomide in Patients with Newly Diagnosed Glioblastoma Multiforme (GBM)","A Multicenter, Single Arm, Open-label, Dose-escalation Phase 2 Study of JK-1201I Combined with Adjuvant Temozolomide in Patients with Newly Diagnosed Glioblastoma Multiforme (GBM) After Surgery and Concomitant Radio-chemotherapy","Inclusion\n\nParticipants must meet all the following criteria to be eligible for randomization into the study:\n\n1. Male or female aged ≥18 years and ≤75 years.\n2. Patients newly diagnosed with glioblastoma either by imaging or pathology testing, Gross total resection equal to or greater than 80%.\n3. Patients must finish concurrent chemo-radiotherapy (CCRT) no sooner than 4 weeks and no later than 6 weeks.\n4. Stable dose or reduced dose of corticosteroid for more than 2 weeks.\n5. Karnofsky score ≥ 70.\n6. Life expectancy \\> 12 weeks.\n7. Adequate biological function.\n8. Men or women should be using adequate contraceptive measures during the study and for 6 months following the last dose of investigational product.\n9. Sign and date the informed consent form prior to the start of any study-specific qualification procedures.\n10. MGMT unmethylation (only for Dose Expansion Cohort).\n\nExclusion\n\nParticipants who meet any of the following criteria will be disqualified from entering the study:\n\n1. Patients who received anti-tumor therapy except for concurrent chemo-radiotherapy (CCRT).\n2. Patient diagnosed with brain stem and spinal cord tumor as the primary tumor.\n3. Hypersensitivity to any ingredient of JK-1201I.\n4. Severe, uncontrolled or active cardiovascular diseases within the past 6 months.\n5. Inability to take medication by oral or presence of clinically significant gastrointestinal abnormalities that may affect absorption of investigational product.\n6. Uncontrolled seizures.\n7. Patient receiving prohibited medications and that cannot be discontinued at least 2 weeks prior to the start of treatment.\n8. Severe or uncontrolled high blood pressure.\n9. Unresolved toxicity from prior anti-tumor therapy.\n10. Women who are pregnant or Breast-feeding. 11 Positive human immunodeficiency virus antibody, active hepatitis B virus infection, or active hepatitis C virus infection.\n\n12\\. Have participated in another clinical trial within 4 weeks prior to informed consent form.\n\n13\\. History of mental disorders. 14. Other conditions that the investigator considers unsuitable to participate in this clinical trial.","ALL","18 Years","75 Years",{"count":20,"type":21},25,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","This study was designed to evaluate the safety, tolerability, efficacy and pharmacokinetics of JK-1201I combined with adjuvant temozolomide in patients with newly diagnosed glioblastoma multiforme after surgery and concomitant radio-chemotherapy.",[27],"Glioblastoma Multiforme (GBM)",[29],"glioblastoma multiforme","RECRUITING","2024-09-11",{"date":33,"type":34},"2024-09-19","ACTUAL",{"date":36,"type":34},"2022-10-31",{"date":38,"type":21},"2026-12-16",{"name":40,"class":41},"JenKem Technology Co., Ltd.","INDUSTRY",1,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":50,"minAge":17,"maxAge":4,"enrollmentInfo":51,"targetDuration":4,"studyType":22,"phases":52,"briefSummary":53,"conditions":54,"keywords":4,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":59,"startDateStruct":60,"completionDateStruct":62,"leadSponsor":64,"locationsCount":4},"100561185","phase-2-jk-1201i-in-triple-negative-breast-cancer-patients-with-brain-metastases-100561185","NCT06586866","JK-1201I in Triple Negative Breast Cancer Patients with Brain Metastases","A Multicenter, Single-Arm, Phase 2 Study to Evaluate the Safety, Efficacy and Pharmacokinetics of JK-1201I in Triple Negative Breast Cancer Patients with Brain Metastases","Inclusion\n\nParticipants must meet all the following criteria to be eligible for randomization into the study:\n\n1. Sign and date the informed consent form prior to the start of any study-specific qualification procedures.\n2. Female aged ≥18 years.\n3. Has ECOG PS of ≤1.\n4. Life expectancy ≥ 3months.\n5. Histological or cytological confirmation of triple-negative breast cancer (TNBC).\n6. At least one prior chemotherapy regimen with anthracyclines and taxanes for advanced disease.\n7. Has at least 1 measurable brain metastatic lesion according to RANO-BM.\n8. Adequate biological function.\n9. Men or women should be using adequate contraceptive measures during the study and for 6 months following the last dose of investigational product.\n\nExclusion\n\nParticipants who meet any of the following criteria will be disqualified from entering the study:\n\n1. Patients who have received prior anti-cancer treatment within 4 weeks.\n2. . Patients must not have previously received JK-1201I or any other form of irinotecan, SN38.\n3. Hypersensitivity to any ingredient of JK-1201I and Topotecan.\n4. Current use or any use in the last two weeks of strong CYP3A-enzyme inducers \u002F in the last two weeks of strong CYP3A-enzyme inhibitors and \u002F or strong UGT1A inhibitors.\n5. Unresolved toxicity from prior anti-tumor therapy, defined as not having resolved to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 grade 1 with exceptions defined in the protocol.\n6. History of other malignancies within last 5 years.\n7. History of immunodeficiency disease, or positive human immunodeficiency virus antibody.\n8. Severe infections within 4 weeks before the first use of the study drug.\n9. Active hepatitis B virus infection, or active hepatitis C virus infection.\n10. Patients who received surgery within last 4 weeks before the initiation of study treatment.\n11. Patients with brain stem, meningeal or spinal cord metastasis.\n12. Severe symptoms by tumor aggressive important organ.\n13. Uncontrolled hydrothorax and ascites.\n14. Uncontrolled concomitant systemic disorder as defined in the protocol.\n15. Serious cardiac condition or uncontrolled high blood pressure.\n16. History of mental illness, drug abuse, alcoholism.\n17. Pregnant or breast-feeding.\n18. Other conditions that the investigator considers unsuitable to participate in this clinical trial.","FEMALE",{"count":20,"type":21},[24],"This study was designed to evaluate the safety, efficacy and pharmacokinetics of JK-1201I in triple negative breast cancer patients with brain metastases.",[55,56],"Triple Negative Breast Cancer (TNBC)","Brain Metastasases","NOT_YET_RECRUITING","2024-09-04",{"date":33,"type":34},{"date":61,"type":21},"2024-09-26",{"date":63,"type":21},"2026-10-26",{"name":40,"class":41},{"id":66,"slug":67,"hasResults":11,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":4,"eligibilityCriteria":71,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":72,"enrollmentInfo":73,"targetDuration":4,"studyType":22,"phases":75,"briefSummary":77,"conditions":78,"keywords":4,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":4},"100560763","phase-3-jk-1201i-compared-with-topotecan-in-patients-with-relapsed-extensive-stage-small-cell-lung-cancer-100560763","NCT06581380","JK-1201I Compared with Topotecan in Patients with Relapsed Extensive Stage Small Cell Lung Cancer","A Multicenter, Randomized, Positive-Controlled, Open-label, Phase 3 Study of JK-1201I Compared with Topotecan in Patients with Relapsed Extensive Stage Small Cell Lung Cancer After Platinum-based First-line Chemotherapy","Inclusion Criteria:\n\nParticipants must meet all the following criteria to be eligible for randomization into the study:\n\n1. Sign and date the informed consent form prior to the start of any study-specific qualification procedures.\n2. Male or female aged ≥18 years and ≤70 years.\n3. Histologically or cytologically documented SCLC.\n4. Has received prior therapy with only one prior platinum-based line as systemic therapy for ES SCLC and Disease progression on or after first-line platinum-based regimens (≤ 6 months).\n5. Has at least 1 measurable lesion according to RECIST v1.1.\n6. Has ECOG PS of ≤1.\n\nExclusion Criteria:\n\nParticipants who meet any of the following criteria will be disqualified from entering the study:\n\n1. Hypersensitivity to any ingredient of JK-1201I and Topotecan.\n2. Has received prior treatment with DNA topoisomerase I inhibitor agents.\n3. Has received prior therapy with ≥2 line as systemic therapy for extensive-stage SCLC.\n4. Chemotherapy-free interval within 4 weeks before the first use of the study drug. Radiotherapy with a limited field of radiation for palliation within 2 weeks before the first use of the study drug. Used biotherapy drugs within 2 weeks before the first use of the study drug.\n5. Severe gastrointestinal illnesses as defined in the protocol within 6 months before the first use of the study drug.\n6. Local symptoms of tumors requiring radiotherapy or surgical treatment as defined in the protocol.\n7. Untreated or symptomatic brain metastases with exceptions defined in the protocol.\n8. Severe pulmonary illnesses within 6 months before the first use of the study drug.\n9. Uncontrolled hydrothorax and ascites.\n10. Unresolved toxicity from prior anti-tumor therapy, defined as not having resolved to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 grade 1 with exceptions defined in the protocol.\n11. Severe infections within 4 weeks before the first use of the study drug.","70 Years",{"count":74,"type":21},394,[76],"PHASE3","This study was designed to compare the efficacy and safety of JK-1201I with Topotecan in patients with relapsed extensive stage small cell lung cancer (ES SCLC).",[79],"Small Cell Lung Cancer","2024-08-29",{"date":82,"type":34},"2024-09-03",{"date":84,"type":21},"2024-09-16",{"date":86,"type":21},"2028-04-16",{"name":40,"class":41},""]