[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Hangzhou GluBio Pharmaceutical Co., Ltd.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":65},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,45],{"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":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100545172","phase-1-a-study-of-glb-001-in-patients-with-myeloid-malignancies-100545172",false,"NCT06378437","A Study of GLB-001 in Patients With Myeloid Malignancies","A Phase 1, Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of GLB-001 in Patients With Myeloid Malignancies","Inclusion Criteria:\n\n* Study participants must understand and voluntarily sign a written informed consent form (ICF) prior to any study-related assessments\u002Fprocedures being performed.\n* Study participants is ≥18 years of age at the time of signing the ICF.\n* Study participants with confirmed diagnosis of relapsed or refractory or intolerant myeloid malignancies including PV, ET, primary myelofibrosis (PMF), MDS and AML according to 2022 World Health Organization (WHO) criteria classification, and post-polycythemia vera myelofibrosis (post-PV MF) and post-essential thrombocythemia myelofibrosis (post-ET MF) according to the 2013 IWG-MRT criteria.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0,1 or 2.\n* Life expectancy \\> 3 months.\n* Good performance of major organs, including hematology, liver and kidney function, and coagulation. etc.\n* Study participants are willing and able to adhere to the study visit schedule and other protocol requirements.\n\nExclusion Criteria:\n\n* Study participants with acute promyelocytic leukemia (APL).\n* Receipt of following anticancer medications\u002Ftherapies prior to the first dose of GLB-001: (1) study participants with PV or ET who received treatment with hydroxyurea within 2 days prior to the first dose, or any other treatment for PV or ET within 7 days prior to first dose of GLB-001, (2) study participants with MF who received any type of treatment for MF within 14 days prior to the first dose, such as chemotherapy, immunotherapy, radiotherapy and erythropoietin, androgens, thrombopoietin or granulocyte colony-stimulating factor, (3) study participants with LR-MDS who received any type of treatment for MDS within 14 days prior to the first dose, (4) study participants with HR-MDS or AML who received chimeric antigen receptor T cell therapy (CAR-T) or other biologic therapy within 28 days prior to the first dose of GLB-001, or received any other anticancer therapies within 14 days prior to the first dose of GLB-001.\n* Receipt of any other investigational drug study within 28 days or 5 half-lives of that study drug before the first dose of GLB-001.\n* Study participants with unresolved clinically significant non-hematologic toxicities that were ≥ Grade 1 or failed to recover to baseline levels following prior anticancer therapies (with the exception of alopecia or skin hyperpigmentation).\n* Study participants who are scheduled to receive other anticancer therapies or other investigational drugs during the study period.\n* Study participants with active acute or chronic graft versus host disease (GVHD) requiring systemic immunosuppressive therapy.\n* Receipt of autologous stem cell transplantation (ASCT) within the last 3 months prior to the first dose of GLB-001, or allogeneic hematopoietic stem cell transplantation (allo-HSCT) within the last 6 months prior to the first dose of GLB-001.\n* Study participants with known active involvement in central nervous system (CNS).\n* Study participants with peripheral neuropathy ≥ Grade 2 (Graded according to CTCAE version 5.0).\n* Study participants have a history of known malignancy other than the inclusion diagnosis for the past 5 years, with the exception of curatively resected cancer in situ, including cervical carcinoma in situ, basal cell carcinoma of the skin, or prostate cancer in situ, etc.\n* QT interval interval \\> 450 milliseconds (ms) using electrocardiographic (ECG) at screening.\n* Study participants have impaired cardiac function or clinically significant cardiac disease at current or within last 6 months.\n* Study participants with known active infection of hepatitis B virus (HBV) or hepatitis C virus C (HCV).\n* Study participants with known human immunodeficiency virus (HIV) infection.\n* Study participants with known life-threatening or clinical significant uncontrolled active systemic infections unrelated to malignant hematologic diseases.\n* Study participants with a state condition that may alter affects the absorption, distribution, metabolism and excretion of GLB-001 after judgment of the investigator.\n* Medications or supplements that are known to be strong and moderate inhibitors or inducers of cytochrome P-450 isozyme 3A (CYP3A) and\u002For P-glycoprotein (P-gp), or strong inhibitors or inducers of CYP450 isozyme 2C8 (CYP2C8) within 7 days or 5 half-lives prior to the first dose of GLB-001, whichever is shorter prior to the first dose of GLB-001.\n* Study participants who have undergone major surgery within 28 days prior to the first dose of the GLB-001, or unability to recover from effects of surgery.\n* Pregnant or lactating women.\n* Study participants who have cognitive impairment due to any psychiatric or neurological condition, including epilepsy and dementia, may limit their understanding, performance, and study compliance with the ICF.\n* Study participants, in the opinion of the Investigator, who are unsuitable to participate in the study.","ALL","18 Years",{"count":19,"type":20},108,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","Study GLB-001-02 is a phase 1, open-label clinical study to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and preliminary efficacy of GLB-001 in study participants with relapsed or refractory or intolerant myeloid malignancies including polycythemia vera (PV), essential thrombocythemia (ET), myelofibrosis (MF), lower-risk myelodysplastic syndrome (LR-MDS), higher-risk myelodysplastic syndromes (HR-MDS), and acute myeloid leukemia (AML). This study consists of 3 parts, dose escalation (Phase 1a), dose exploration (Phase 1b) and dose expansion (Phase 1c). Dose escalation (Phase 1a) and dose exploration (Phase 1b) will evaluate the safety, tolerability, PK, PD and preliminary efficacy of GLB-001, administered orally, in study participants with PV\u002FET, or study participants with MF\u002FLR-MDS\u002FHR-MDS\u002FAML, respectively. Dose expansion (Phase 1c) will be followed to determine the relationships among dose, exposure, toxicity, tolerability and clinical activity, to identify minimally active dose, and to select the recommended dose(s) for phase 2 study. Approximately 108 study participants may be enrolled in the study.",[26,27,28,29,30,31],"Polycythemia Vera","Essential Thrombocythemia","Myelofibrosis","Myelodysplastic Syndromes","Acute Myeloid Leukemia","Myeloid Malignancy","RECRUITING","2025-08-17",{"date":35,"type":36},"2025-08-19","ACTUAL",{"date":38,"type":36},"2024-05-24",{"date":40,"type":20},"2027-12-31",{"name":42,"class":43},"Hangzhou GluBio Pharmaceutical Co., Ltd.","INDUSTRY",14,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":21,"phases":54,"briefSummary":55,"conditions":56,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":58,"startDateStruct":59,"completionDateStruct":61,"leadSponsor":63,"locationsCount":64},"100532941","phase-1-a-study-of-glb-002-in-patients-with-relapsed-or-refractory-non-hodgkin-lymphomas-100532941","NCT06219356","A Study of GLB-002 in Patients With Relapsed or Refractory Non-Hodgkin Lymphomas","A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of GLB-002 in Patients With Relapsed or Refractory Non-Hodgkin Lymphomas (R\u002FR NHL)","Inclusion Criteria:\n\n* Participants must understand and voluntarily sign a written informed consent form (ICF) prior to any study-related assessments\u002Fprocedures being performed.\n* Participants is ≥18 years of age at the time of signing the ICF.\n* Participants with histopathologically or immunohistochemically confirmed NHL according to 2016 World Health Organization (WHO) haematolymphoid tumors criteria classification (CLL\u002FSLL diagnosis according to 2018 IWCLL) who have failed standard of care therapy or lack an effective treatment regimen.\n* Participants in Phase Ib screening period with measurable lesion, but no measurable nodal lesion limit for participants in Phase Ia.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0,1 or 2.\n* Life expectancy \\> 3 months.\n* Good performance of major organs, including hematology, liver and kidney function, and coagulation. etc.\n* Participants are willing and able to adhere to the study visit schedule and other protocol requirements.\n\nExclusion Criteria:\n\n* Receipt of anticancer medications\u002Ftherapies such as chemotherapy, targeted therapy, immunotherapy, biologic therapy, or herbal agent ≤ 28 days or 5 half-lives, whichever is shorter, prior to the first dose of GLB-002; or chimeric antigen receptor T cell therapy (CAR-T) within 3 months prior to the first dose of GLB-002.\n* Currently enrolled in any other investigational drug study or participation within the last 28 days or 5 half-lives, whichever is shorter, prior to the first dose of GLB-002 (exception of participants who participated in only one investigational drug study with overall survival follow-up).\n* Participants with unresolved clinically significant toxicities of \\> Grade 1 AE or not be recovered to baseline value from prior anticancer therapies with exception of alopecia or hyperpigmentation of the skin.\n* Participants who are scheduled to receive other anticancer therapies or other investigational drugs during the study period.\n* Participants with active acute or chronic graft versus host disease (GVHD) requiring systemic immunosuppressive therapy, or participants requiring treatment with systemic corticosteroids (\\>10 mg\u002Fday prednisone or equivalent) or other immunosuppressive drugs within the last 7 days prior to the first dose of GLB-002 or during the study period.\n* Receipt of Autologous Stem Cell Transplantation (ASCT) within the last 3 months, or allogeneic hematopoietic stem cell transplantation (allo-HSCT) within the last 6 months prior to the first dose of GLB-002.\n* Participants with known active leukemic involvement in central nervous system (CNS).\n* Participants with peripheral neuropathy ≥ Grade 2 (Graded according to CTCAE version 5.0).\n* History of, or current active cancer other malignancy for the past 5 years, with the exception of curatively resected cancer in situ, including cervical carcinoma in situ, basal cell carcinoma of the skin, or prostate cancer in situ, etc\n* QT interval interval \\>470 milliseconds (ms) using electrocardiographic (ECG) at Screening.\n* Participants has impaired cardiac function or clinically significant cardiac disease at current or within last 6 months.\n* Participants with known active infection of hepatitis B virus (HBV) or hepatitis C virus C (HCV).\n* Participants with known human immunodeficiency virus (HIV) infection.\n* Participants with known life-threatening or clinical significant uncontrolled active systemic infections unrelated to malignant hematologic diseases\n* Participants with a condition that may affects the absorption, distribution, metabolism and excretion of GLB-002.\n* Medications or supplements that are known to be strong and moderate inhibitors or inducers of cytochrome P-450 isozyme (CYP)3A4\u002F5 and\u002For P-glycoprotein (P-gp) within 7 days or 5 half-lives prior to the first dose of GLB-002, whichever is shorter.\n* Participants who have undergone major surgery within 28 days prior to the first dose of the GLB-002.\n* Pregnant or lactating women.\n* Participants who have cognitive impairment due to any psychiatric or neurological condition, including epilepsy and dementia, may limit their understanding, performance, and study compliance with the ICF.\n* Participants,in the opinion of the Investigator, who are unsuitable to participate in the study.",{"count":53,"type":20},110,[23],"Study GLB-002-01 is a first-in-human (FIH), phase 1, open-label, dose escalation and expansion clinical study, the purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and preliminary efficacy of GLB-002 monotherapy in participants with relapsed or refractory Non-Hodgkin lymphomas (R\u002FR NHL).",[57],"Non-Hodgkin Lymphoma",{"date":35,"type":36},{"date":60,"type":36},"2024-01-11",{"date":62,"type":20},"2027-02-28",{"name":42,"class":43},13,""]