[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100586015":3},{"organization":4,"outcomesModule":7,"designInfo":72,"detailedDescription":79,"studyPopulation":75,"armGroups":80,"interventions":87,"overallOfficials":95,"centralContacts":100,"locations":106,"responsibleParty":124,"collaborators":75,"id":126,"slug":75,"hasResults":127,"nctId":128,"briefTitle":129,"officialTitle":130,"acronym":75,"eligibilityCriteria":131,"healthyVolunteers":127,"sex":132,"minAge":133,"maxAge":134,"enrollmentInfo":135,"targetDuration":75,"studyType":138,"phases":139,"briefSummary":142,"conditions":143,"keywords":145,"overallStatus":109,"whyStopped":75,"lastUpdateSubmitDate":148,"lastUpdatePostDateStruct":149,"startDateStruct":152,"completionDateStruct":154,"leadSponsor":156,"locationsCount":157},{"fullName":5,"class":6},"Haihe Biopharma Co., Ltd.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":16,"otherOutcomes":65},[9,13],{"measure":10,"description":11,"timeFrame":12},"Phase Ib: To determine the RP2D of HH2853 in PTCL patients","Determine RP2D of HH2853","28-day treatment cycles",{"measure":14,"description":15,"timeFrame":12},"Phase II: To evaluate the efficacy of HH2853 of R\u002FR PTCL patients who have received at least one prior systemic combination chemotherapy and at least one new drug","ORR will be based on the blinded independent review committee (BIRC). Assessment of oncologic response will be performed according to the 2014 edition of the Lugano Criteria for Efficacy \\[Lugano\\]",[17,20,22,24,26,29,31,33,35,37,39,42,44,46,47,48,49,51,53,56,58,59,61,62,63],{"measure":18,"description":19,"timeFrame":12},"Phase Ib: 1. Preliminary efficacy of HH2853 in R\u002FR PTCL patients;","Investigator assessed: complete response rate (CRR)",{"measure":18,"description":21,"timeFrame":12},"Duration of response (DoR)",{"measure":18,"description":23,"timeFrame":12},"Disease control rate (DCR)",{"measure":18,"description":25,"timeFrame":12},"Time to response (TTR)",{"measure":27,"description":28,"timeFrame":12},"Phase Ib: 2.To characterize the pharmacokinetic profile of HH2853","Area under the concentration-time curve (AUC)",{"measure":27,"description":30,"timeFrame":12},"Maximum plasma concentration (Cmax)",{"measure":27,"description":32,"timeFrame":12},"Trough concentration (Cmin)",{"measure":27,"description":34,"timeFrame":12},"Time to maximum plasma concentration (Tmax)",{"measure":27,"description":36,"timeFrame":12},"Apparent clearance (CL\u002FF)",{"measure":27,"description":38,"timeFrame":12},"Terminal half-life (t1\u002F2)",{"measure":40,"description":41,"timeFrame":12},"Phase II: 1.To further assess the other efficacy of HH2853 of R\u002FR PTCL patients who have received at least one prior systemic combination chemotherapy and at least one new drug (such as Chidamide, Pralatrexate and Brentuximab vedotin, et al.) therapy","ORR assessed by investigator",{"measure":40,"description":43,"timeFrame":12},"Complete response rate (CRR)",{"measure":40,"description":45,"timeFrame":12},"Progression-free survival (PFS)",{"measure":40,"description":21,"timeFrame":12},{"measure":40,"description":23,"timeFrame":12},{"measure":40,"description":25,"timeFrame":12},{"measure":40,"description":50,"timeFrame":12},"Overall survival (OS) by BIRC",{"measure":40,"description":52,"timeFrame":12},"Overall survival (OS) by investigator",{"measure":54,"description":55,"timeFrame":12},"Phase II: 2. To evaluate the safety and tolerability of HH2853","Duration and severity of adverse events (AEs)",{"measure":57,"description":28,"timeFrame":12},"Phase II: 3. To characterize the population pharmacokinetic profile of HH2853",{"measure":57,"description":30,"timeFrame":12},{"measure":57,"description":60,"timeFrame":12},"Steady-state trough concentration (Cmin)",{"measure":57,"description":34,"timeFrame":12},{"measure":57,"description":36,"timeFrame":12},{"measure":57,"description":64,"timeFrame":12},"Half life (t1\u002F2)",[66,69],{"measure":67,"description":68,"timeFrame":12},"Phase Ib and II: 1. To explore biomarkers related to response and effect of HH2853","mutation status of EZH2",{"measure":70,"description":71,"timeFrame":12},"Phase Ib and II: 2. To explore the correlation between HH2853 exposure with safety, efficacy and pharmacokinetic parameters","Correlation between exposure (Cmax or AUC) and safety\u002Fefficacy\u002Fpharmacodynamic biomarkers (trimethylation of histone H3 at lysine 27 \\[H3K27me3\\])",{"allocation":73,"interventionModel":74,"interventionModelDescription":75,"primaryPurpose":76,"observationalModel":75,"timePerspective":75,"maskingInfo":77},"NA","SINGLE_GROUP",null,"TREATMENT",{"masking":78,"maskingDescription":75,"whoMasked":75},"NONE","This study includes Phase Ib and Phase II. In the Phase Ib, patients with R\u002FR NHL (dose escalation) or R\u002FR PTCL (dose expansion) who have received at least 1 line of prior systematic treatment and meet the inclusion\u002Fexclusion criteria in the protocol will be enrolled. Safety run-in study (Japan only): The objective of the safety run-in study in Japan is to evaluate the safety, tolerability, and PK profile of HH2853 in Japanese patients. The primary objective of the Phase Ib study is to determine the RP2D of HH2853 in PTCL patients. The secondary objectives are to evaluate the safety, preliminary efficacy and characterize the pharmacokinetic profile of HH2853 in R\u002FR PTCL patients. A \"3+3\" design will be used in the dose escalation part with a starting dose of 400 mg BID. Based on the safety, efficacy and PK\u002FPD data and HH2853-G101 data, 1-2 dose levels could be expanded, 10-15 R\u002FR PTCL patients for each dose level. Approximately 21-48 patients will be enrolled in total.\n\nIn the Phase II (multi-national): patients with R\u002FR PTCL who have received at least one prior systemic combination chemotherapy and at least one new drug therapy and meet the inclusion\u002Fexclusion criteria in the protocol will be enrolled. The Phase II study will be started once the RP2D is determined. The Phase II study is a single-arm study and will be enrolled in approximately 66 efficacy-evaluable R\u002FR PTCL patients who had received at least one prior systemic combination chemotherapy and at least one new drug therapy. The primary objective of the Phase II study is to evaluate the efficacy of HH2853 of R\u002FR PTCL patients who have received at least one prior systemic combination chemotherapy and at least one new drug therapy (ORR, BIRC evaluation); The secondary objectives will be continued to further evaluate the efficacy, safety, tolerability and PK characteristics of HH2853 of R\u002FR PTCL patients who have received at least 1 line of prior systemic therapy.",[81],{"label":82,"type":83,"description":84,"interventionNames":85},"Dose escalation and expansion study of HH2853","EXPERIMENTAL","To determine the RP2D of HH2853 in PTCL patients.",[86],"Drug: HH2853 Tablets",[88],{"type":89,"name":90,"description":91,"armGroupLabels":92,"otherNames":93},"DRUG","HH2853 Tablets","25mg, 100mg and 200 mg BID oral administration",[82],[94],"HH2853",[96],{"name":97,"affiliation":98,"role":99},"Tongyu Li, MD","Sichuan Cancer Hospital and Research Institute","PRINCIPAL_INVESTIGATOR",[101],{"name":102,"role":103,"phone":104,"phoneExt":75,"email":105},"Haiying Jia","CONTACT","86-20568888","haiying.jia@haihepharma.com",[107],{"facility":108,"status":109,"city":110,"state":110,"zip":75,"country":111,"countryCode":112,"cosmosGeoPoint":113,"geoPoint":118,"contacts":119},"Sichuan Cancer Hospital","RECRUITING","Chengdu","China","CN",{"type":114,"coordinates":115},"Point",[116,117],104.06667,30.66667,{"lat":117,"lon":116},[120],{"name":121,"role":103,"phone":122,"phoneExt":75,"email":123},"Huangming Hong, MD","86-13570431657","honghm3@mail.sysu.edu.cn",{"type":125,"investigatorFullName":75,"investigatorTitle":75,"investigatorAffiliation":75,"oldNameTitle":75,"oldOrganization":75},"SPONSOR","100586015",false,"NCT06909877","Study to Evaluate Efficacy and Safety of HH2853 in Relapsed\u002FRefractory Peripheral T-cell Lymphoma","An Open-label, Multinational, Multicenter, Single-arm Phase Ⅰb\u002FⅡ Study to Evaluate Efficacy and Safety of Oral HH2853, a Selective EZH1\u002F2 Inhibitor, in Patients With Relapsed\u002FRefractory Peripheral T-cell Lymphoma","Inclusion Criteria:\n\n* main inclusion:\n\n  1. Tumor types and prior antitumor therapy: Phase Ib:Dose Escalation: All enrolled patients must have histologically confirmed diagnosis NHL who have received at least one line of prior systematic treatment (and ≤ 5 lines) and relapses or refractory. Phase Ib dose expansion part: All enrolled patients must have histologically confirmed diagnosis of PTCL, including subtypes: PTCL-NOS, AITL, ALK + ALCL, ALK-ALCL, NKTCL, enteropathy associated T-cell lymphoma (EATL), monomorphic epitheliotropic internal T-cell lymphoma (MEITL), Hepatosplenic T-cell lymphoma (HSTCL), follicular T-cell lymphoma (FTCL), Nodal peripheral T-cell lymphoma with TFH phenotype (Nodal PTCL-TFH) and other invasive T-cell sources NHL at the investigator and sponsor's discretion (except highly invasive). All enrolled patients had relapsed or refractory diseases after receiving 1-line systematic treatment (≤ 3 lines). Phase II: All enrolled patients must have histologically confirmed diagnosis of PTCL, including subtypes: PTCL-NOS, AITL, ALK+ALCL, ALK-ALCL, NKTCL, EATL, MEITL, HSTCL, FTCL, Nodal PTCL-TFH et al. Patients must have histologically confirmed diagnosis of R\u002FR PTCL who have received at least one line of prior systematic combination chemotherapy and at least one new drug therapy (prior antitumor treatment lines ≤4 lines) : relapse and\u002For refractory.\n  2. Availability of qualified tissue samples by patient for pathological diagnosis by the central laboratory.\n  3. The Eastern cooperative oncology group (ECOG) score 0-1.\n  4. Life expectancy ≥ 3 months before starting HH2853 treatment.\n  5. Sufficient bone marrow, liver and renal functions.\n\nExclusion Criteria:\n\n* main criteria:\n\n  1. Previous treatment with EZH2 or EZH1\u002F2 inhibitors.\n  2. Central nervous system invasion.\n  3. Any previous history of bone marrow malignancy, including myelodysplastic syndrome (MDS).\n  4. Received medications that are known potent CYP3A4 inducers\u002Finhibitors within 1 week prior to first dose.","ALL","18 Years","75 Years",{"count":136,"type":137},100,"ESTIMATED","INTERVENTIONAL",[140,141],"PHASE1","PHASE2","This study is a an open-label, multinational, multicenter, single-arm Phase Ⅰb\u002FⅡ Study to Evaluate Efficacy and Safety of Oral HH2853 in Patients with Relapsed\u002FRefractory Peripheral T-cell Lymphoma.",[144],"Relapsed\u002FRefractory Peripheral T-Cell Lymphoma (R\u002FR PTCL)",[146,147],"Relapsed\u002FRefractory","Peripheral T-cell Lymphoma","2026-01-28",{"date":150,"type":151},"2026-01-30","ACTUAL",{"date":153,"type":151},"2022-07-27",{"date":155,"type":137},"2027-07-30",{"name":5,"class":6},1]