[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Tarapeutics Science Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":105},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,41,64,88],{"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":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100642650","phase-3-tr115-vs-investigators-choice-in-relapsedrefractory-peripheral-tnk-cell-lymphoma-100642650",false,"NCT07639879","TR115 VS Investigator's Choice in Relapsed\u002FRefractory Peripheral T\u002FNK Cell Lymphoma","A Randomized, Controlled, Open-label, Multicenter Phase III Trial to Evaluate the Efficacy and Safety of TR115 in Patients With Relapsed and\u002For Refractory Peripheral T\u002FNK-Cell Lymphoma","Inclusion Criteria:\n\n* Histologically confirmed peripheral T-cell lymphoma (PTCL), including PTCL-NOS, AITL, ALCL, or NKTCL\n* Received at least one prior systemic therapy and prior exposure to at least one novel agent (e.g., chidamide, pralatrexate, brentuximab vedotin, etc.) or refractory\u002Fintolerant to such therapies\n* Age ≥18 years\n* ECOG performance status 0-1\n* At least one measurable lesion per Lugano 2014 criteria (lymph node ≥1.5 cm in longest diameter or extranodal lesion ≥1.0 cm)\n* Adequate organ function, defined as: ANC ≥1.5 × 10⁹\u002FL, Platelets ≥100 × 10⁹\u002FL, Hemoglobin ≥100 g\u002FL, Total bilirubin ≤1.5 × ULN, ALT\u002FAST ≤2.5 × ULN (≤5 × ULN if liver involvement), Creatinine clearance ≥50 mL\u002Fmin (Cockcroft-Gault), LVEF ≥50%, QTcF \\\u003C450 ms (male), \\\u003C470 ms (female)\n* Willingness to provide archival or fresh tumor tissue\n* Life expectancy ≥3 months\n\nExclusion Criteria:\n\n* Prior treatment with EZH2 or EZH1\u002F2 inhibitors resulting in disease progression (intolerance permitted)\n* Known central nervous system involvement of lymphoma\n* Active uncontrolled infection requiring systemic therapy\n* Significant or uncontrolled cardiovascular disease\n* Prior allogeneic stem cell transplantation or autologous stem cell transplantation within 90 days prior to first dose\n* Pregnancy or lactation, or unwillingness to use effective contraception\n* Other malignancies within 5 years, except adequately treated basal cell carcinoma, squamous cell carcinoma, carcinoma in situ, or thyroid carcinoma\n* Patients planned to receive mitoxantrone liposomal therapy with prior cumulative doxorubicin exposure ≥350 mg\u002Fm² (or equivalent anthracycline exposure)","ALL","18 Years",{"count":19,"type":20},180,"ESTIMATED","INTERVENTIONAL",[23],"PHASE3","This is a randomized, open-label, multicenter Phase III study evaluating the efficacy and safety of TR115, an EZH2 inhibitor, versus investigator's choice (chidamide, golidocitinib, mitoxantrone liposome, or gemcitabine) in patients with relapsed and\u002For refractory peripheral T\u002FNK-cell lymphoma. Approximately 180 patients will be randomized in a 1:1 ratio. The primary endpoint is progression-free survival (PFS) assessed by an Independent Review Committee (IRC). The key secondary endpoint is overall survival (OS). The study is being conducted at approximately 40 to 60 centers across China.",[26,27],"PTCL","NK T-Cell Lymphoma","NOT_YET_RECRUITING","2026-06-06",{"date":31,"type":32},"2026-06-10","ACTUAL",{"date":34,"type":20},"2026-07-30",{"date":36,"type":20},"2030-07-30",{"name":38,"class":39},"Tarapeutics Science Inc.","INDUSTRY",1,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":48,"targetDuration":4,"studyType":21,"phases":50,"briefSummary":52,"conditions":53,"keywords":4,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":56,"lastUpdatePostDateStruct":57,"startDateStruct":59,"completionDateStruct":61,"leadSponsor":63,"locationsCount":40},"100457783","phase-2-a-study-of-hyml-122-and-cytarabine-in-patients-with-flt3-positive-relapsed-or-refractory-acute-myeloid-leukemia-aml-100457783","NCT05241093","A Study of HYML-122 and Cytarabine in Patients With FLT3 Positive Relapsed or Refractory Acute Myeloid Leukemia (AML)","A Single-arm, Open, Multicenter, Phase II Study to Investigator the Efficacy and Safety of HYML-122 and Cytarabine in Patients With FLT3 Positive Relapsed or Refractory Acute Myeloid Leukemia (AML)","Inclusion Criteria:\n\n* Fully understand the procedures of the clinical study and participate voluntarily with signed and dated written informed consent form, comply with the requirements of the study protocol.\n* Males and\u002For females at least 18 years old when signing the informed consent form.\n* Histologically confirmed AML (defined using WHO criteria 2016) with one of the following: Refractory to at least 1 cycle of induction chemotherapy. Relapsed after achieving remission with a prior therapy.\n* Subject is positive for FLT3 mutation in bone marrow or blood after completion of the subject's last interventional treatment.\n* Eastern cooperative oncology group performance status (ECOG) ≤2 at screening.\n* Life expectancy of at least 3 months.\n* Women of childbearing potential have a negative pregnancy test at baseline and are willing to employ an effective method of contraception for the entire duration of study treatment and 6 months after the last dose.\n\nExclusion Criteria:\n\n* Known or suspected allergies to any of the investigational drug composition (HYML-122, lactose, hydroxypropyl cellulose, hyposubstituted hydroxypropyl cellulose, silicon dioxide, magnesium stearate, titanium dioxide and polyethylene glycol).\n* Medical history and surgical history excluded according to the protocol.\n* Any previous medical treatment history exclude from the protocol.\n* Abnormal laboratory results exclude from the protocol.\n* Combination of treatments and\u002For drugs required during the study period and cannot be discontinued that excluded from the protocol.\n* Alcohol abuse within 6 months prior to screening, defined as long-term drinking history, generally more than 5 years, equivalent to alcohol quantity ≥40g\u002Fd for men, ≥20g\u002Fd for women, or heavy drinking history within 2 weeks, equivalent to alcohol quantity ≥80g\u002Fd. alcohol volume (g) conversion formula=alcohol consumption (mL)\\*alcohol content (%)\\*0.8.\n* Abortion less than 30 days prior to screening, pregnant and lactating women (currently breast-feeding or less than one year after delivery although not breast-feeding), women of childbearing potential who are not guaranteed effective contraception during the study, planning pregnancy or donating eggs or sperm within 6 months after the last dose.\n* History of drug abuse or drug addicts.\n* Subjects may not be able to complete the study duo to poor compliance or other reasons, or unsuitable for the study by the investigator's judgment.",{"count":49,"type":20},18,[51],"PHASE2","This is a single-arm, open, multicenter, phase 2 study to evaluate the efficacy, safety and pharmacokinetics of HYLM-122 in combination with cytarabine in Chinese subjects with FLT3 positive relapsed or refractory acute myeloid leukemia.",[54],"Relapsed or Refractory Acute Myeloid Leukemia (AML)","RECRUITING","2025-04-09",{"date":58,"type":32},"2025-04-10",{"date":60,"type":32},"2022-03-29",{"date":62,"type":20},"2026-06-30",{"name":38,"class":39},{"id":65,"slug":66,"hasResults":11,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":4,"eligibilityCriteria":70,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":71,"enrollmentInfo":72,"targetDuration":4,"studyType":21,"phases":74,"briefSummary":76,"conditions":77,"keywords":4,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":87},"100489148","phase-1-tr64-in-patients-with-advanced-solid-tumors-100489148","NCT05649345","TR64 in Patients With Advanced Solid Tumors","A Single-arm, Open-Label, Dose Escalation , Phase I Study to Evaluate the Safety, Tolerability and Pharmacokinetics of TR64 in Patients With Advanced Solid Tumors","Inclusion Criteria:\n\n* Fully understand the procedures of the clinical study and participate voluntarily with signed and dated written informed consent form, comply with the requirements of the study protocol.\n* Males and\u002For females at least 18 years old when signing the informed consent form.\n* Histologically or cytologically confirmed patients with advanced malignant solid tumors, eligible patients must have failed standard treatment, no standard treatment, or not suitable for standard treatment at this stage as determined by the investigator.\n* Measurable disease with at least one lesion amenable to response assessment per RECIST 1.1.\n* Eastern cooperative oncology group performance status (ECOG) ≤2 at screening.\n* Life expectancy of at least 3 months.\n* Acceptable organ function: Absolute neutrophil count(ANC)≥1.5×109\u002FL; Platelet count(PLT)≥90×109\u002FL; Hemoglobin(Hb)≥90 g\u002FL; Total bilirubin(TBIL)≤1.5×Upper limit of normal value(ULN); Alanine aminotransferase(ALT)≤2.5×ULN; Aspartate aminotransferase(AST)≤2.5×ULN; Creatinine clearance ≥50ml\u002Fmin.\n* Fertile male and female must agree to use medically approved contraceptives during the study and within 90 days after the last dose of the study.\n\nExclusion Criteria:\n\n* Known or suspected allergies to any of the investigational drug composition.\n* Medical history and surgical history excluded according to the protocol.\n* Any previous medical treatment history exclude from the protocol.\n* Abnormal laboratory results exclude from the protocol.\n* pregnant and lactating women (currently breast-feeding or less than six months after delivery although not breast-feeding).\n* Subjects may not be able to complete the study duo to poor compliance or other reasons, or unsuitable for the study by the investigator's judgment.","75 Years",{"count":73,"type":20},19,[75],"PHASE1","This is a open-label, dose escalation, accelerated titration combined 3+3 design, phase I study, to evaluate the safety and tolerability, and to determine the RP2D of TR64 when administered qd in patients with advanced solid tumors. Up to 6 cohorts of 1-6 or 3-6 patients each will be treated in the study.",[78],"Advanced Solid Tumor","2024-05-13",{"date":81,"type":32},"2024-05-14",{"date":83,"type":32},"2023-01-12",{"date":85,"type":20},"2026-12-30",{"name":38,"class":39},2,{"id":89,"slug":90,"hasResults":11,"nctId":91,"briefTitle":92,"officialTitle":93,"acronym":4,"eligibilityCriteria":94,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":95,"targetDuration":4,"studyType":21,"phases":97,"briefSummary":98,"conditions":99,"keywords":4,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":100,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":104,"locationsCount":40},"100457784","phase-2-a-study-of-hyml-122-in-patients-with-flt3-positive-relapsed-or-refractory-acute-myeloid-leukemia-aml-100457784","NCT05241106","A Study of HYML-122 in Patients With FLT3 Positive Relapsed or Refractory Acute Myeloid Leukemia (AML)","a Single-arm, Open, Multicenter, Phase II Study to Investigator the Efficacy and Safety of HYML-122 in Patients With FLT3 Positive Relapsed or Refractory Acute Myeloid Leukemia (AML)","Inclusion Criteria:\n\n* Fully understand the procedures of the clinical study and participate voluntarily with signed and dated written informed consent form, comply with the requirements of the study protocol.\n* Males and\u002For females at least 18 years old when signing the informed consent form.\n* Histologically confirmed AML (defined using WHO criteria 2016) with one of the following:\n\nRefractory to at least 1 cycle of induction chemotherapy. Relapsed after achieving remission with a prior therapy.\n\n* Subject is positive for FLT3 mutation in bone marrow or blood after completion of the subject's last interventional treatment.\n* Eastern cooperative oncology group performance status (ECOG) ≤2 at screening.\n* Life expectancy of at least 3 months.\n* Women of childbearing potential have a negative pregnancy test at baseline and are willing to employ an effective method of contraception for the entire duration of study treatment and 6 months after the last dose.\n\nExclusion Criteria:\n\n* Known or suspected allergies to any of the investigational drug composition (HYML-122, lactose, hydroxypropyl cellulose, hyposubstituted hydroxypropyl cellulose, silicon dioxide, magnesium stearate, titanium dioxide and polyethylene glycol).\n* Medical history and surgical history excluded according to the protocol.\n* Any previous medical treatment history exclude from the protocol.\n* Abnormal laboratory results exclude from the protocol.\n* Combination of treatments and\u002For drugs required during the study period and cannot be discontinued that excluded from the protocol.\n* Alcohol abuse within 6 months prior to screening, defined as long-term drinking history, generally more than 5 years, equivalent to alcohol quantity ≥40g\u002Fd for men, ≥20g\u002Fd for women, or heavy drinking history within 2 weeks, equivalent to alcohol quantity ≥80g\u002Fd. alcohol volume (g) conversion formula=alcohol consumption (mL)\\*alcohol content (%)\\*0.8.\n* Abortion less than 30 days prior to screening, pregnant and lactating women (currently breast-feeding or less than one year after delivery although not breast-feeding), women of childbearing potential who are not guaranteed effective contraception during the study, planning pregnancy or donating eggs or sperm within 6 months after the last dose.\n* History of drug abuse or drug addicts.\n* Subjects may not be able to complete the study duo to poor compliance or other reasons, or unsuitable for the study by the investigator's judgment.",{"count":96,"type":20},15,[51],"this is a single-arm, open, multicenter, phase 2 study to evaluate the efficacy, safety and pharmacokinetics of HYLM-122 monotherapy in Chinese subjects with FLT3 positive relapsed or refractory acute myeloid leukemia.",[54],{"date":81,"type":32},{"date":102,"type":32},"2021-09-29",{"date":62,"type":20},{"name":38,"class":39},""]