[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100438777":3},{"organization":4,"outcomesModule":7,"designInfo":38,"detailedDescription":45,"studyPopulation":37,"armGroups":46,"interventions":72,"overallOfficials":78,"centralContacts":83,"locations":91,"responsibleParty":137,"collaborators":37,"id":139,"slug":37,"hasResults":140,"nctId":141,"briefTitle":142,"officialTitle":143,"acronym":37,"eligibilityCriteria":144,"healthyVolunteers":140,"sex":145,"minAge":146,"maxAge":147,"enrollmentInfo":148,"targetDuration":37,"studyType":151,"phases":152,"briefSummary":154,"conditions":155,"keywords":37,"overallStatus":94,"whyStopped":37,"lastUpdateSubmitDate":157,"lastUpdatePostDateStruct":158,"startDateStruct":161,"completionDateStruct":163,"leadSponsor":165,"locationsCount":166},{"fullName":5,"class":6},"Guangzhou Lupeng Pharmaceutical Company LTD.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":18,"otherOutcomes":37},[9,13,16],{"measure":10,"description":11,"timeFrame":12},"Maximum Tolerated Dose (MTD)","Phase 1a","Up to 24 Months",{"measure":14,"description":15,"timeFrame":12},"Recommended dose for Phase2 (RP2D)","Phase Ia\u002FIb",{"measure":17,"description":15,"timeFrame":12},"To evaluate the safety of LP-168 by assessing incidence and severity of treatment-emergent adverse events as determined by CTCAE v5.0",[19,22,25,28,31,33,35],{"measure":20,"description":21,"timeFrame":12},"Overall Response Rate","To assess the preliminary anti-tumor activity of LP-168 based on overall response rate (ORR) as assessed by investigator and IRC.",{"measure":23,"description":24,"timeFrame":12},"Progression Free Survival","To assess the preliminary anti-tumor activity of LP-168 based on Progression free survival (PFS) as assessed by the Investigator and IRC",{"measure":26,"description":27,"timeFrame":12},"Duration of Response","To assess the preliminary anti-tumor activity of LP-168 based on Duration of response (DOR) as assessed by the Investigator and IRC.",{"measure":29,"description":15,"timeFrame":30},"Pharmacokinetics (PK) As Assessed By Maximum Observed Plasma Concentration (Cmax) Of LP-168","Up to 48 hours post dose",{"measure":32,"description":15,"timeFrame":30},"PK As Assessed By Area Under The Plasma Concentration Time Curve From Time 0 To The Time Of The Last Quantifiable Concentration (AUC0-t) Of LP-168",{"measure":34,"description":15,"timeFrame":30},"PK As Assessed By Time To Maximum Observed Plasma Concentration (Tmax) Of LP-168",{"measure":36,"description":15,"timeFrame":30},"PK As Assessed By Terminal Half-life (t1\u002F2) Of LP-168",null,{"allocation":39,"interventionModel":40,"interventionModelDescription":41,"primaryPurpose":42,"observationalModel":37,"timePerspective":37,"maskingInfo":43},"NON_RANDOMIZED","PARALLEL","Dose Escalation and determination of MTD; multiple dose levels of LP-168 to be evaluated","TREATMENT",{"masking":44,"maskingDescription":37,"whoMasked":37},"NONE","This study includes 2 parts: phase 1a (LP-168 monotherapy dose escalation) and phase 1b (LP-168 dose expansion). In phase 1a, patients will be enrolled using an 3+3 design. The starting dose of LP-168 in oral tablet form is 100 mg\u002Fday (e.g., 100 mg once daily \\[QD\\]). Once the MTD and\u002For RP2D is identified in phase 1a dose escalation, enrollment will continue to phase 1b dose expansion. Cycle length will be 28 days.",[47,52,56,60,64,68],{"label":48,"type":49,"description":41,"interventionNames":50},"Phase I Dose Escalation","EXPERIMENTAL",[51],"Drug: LP-168 tablet",{"label":53,"type":49,"description":54,"interventionNames":55},"Phase I Dose Expansion A","CLL\u002FSLL patients treated with prior regimens.",[51],{"label":57,"type":49,"description":58,"interventionNames":59},"Phase I Dose Expansion B","CLL\u002FSLL patients with no prior therapy.",[51],{"label":61,"type":49,"description":62,"interventionNames":63},"Phase I Dose Expansion C","MCL patients treated with prior regimens.",[51],{"label":65,"type":49,"description":66,"interventionNames":67},"Phase I Dose Expansion D","WM patients treated with prior regimens.",[51],{"label":69,"type":49,"description":70,"interventionNames":71},"Phase I Dose Expansion E","MZL patients treated with prior regimens.",[51],[73],{"type":74,"name":75,"description":76,"armGroupLabels":77,"otherNames":37},"DRUG","LP-168 tablet","Subjects to take LP-168 orally with 240mL water, without food, Once daily or twice daily",[48,53,57,61,65,69],[79],{"name":80,"affiliation":81,"role":82},"Jun Zhu","Peking University Cancer Hospital & Institute","STUDY_CHAIR",[84,89],{"name":85,"role":86,"phone":87,"phoneExt":37,"email":88},"Jun Zhu, MD, PhD","CONTACT","+86-010-88196596","zj@bjcancer.org",{"name":90,"role":86,"phone":37,"phoneExt":37,"email":37},"Yuqin Song, MD, PhD",[92,111,122],{"facility":93,"status":94,"city":95,"state":96,"zip":97,"country":98,"countryCode":99,"cosmosGeoPoint":100,"geoPoint":105,"contacts":106},"Peking University Third Hospital","RECRUITING","Beijing","Beijing Municipality","100089","China","CN",{"type":101,"coordinates":102},"Point",[103,104],116.39723,39.9075,{"lat":104,"lon":103},[107],{"name":108,"role":86,"phone":109,"phoneExt":37,"email":110},"Hongmei Jing, M.D.","+861082265531","hongmei_jing@163.com",{"facility":112,"status":94,"city":95,"state":96,"zip":113,"country":98,"countryCode":99,"cosmosGeoPoint":114,"geoPoint":116,"contacts":117},"Beijing Cancer Hospital","100142",{"type":101,"coordinates":115},[103,104],{"lat":104,"lon":103},[118],{"name":119,"role":86,"phone":120,"phoneExt":37,"email":121},"Yuqin Song","+861088196596","SongYQ_VIP@163.com",{"facility":123,"status":94,"city":124,"state":125,"zip":126,"country":98,"countryCode":99,"cosmosGeoPoint":127,"geoPoint":131,"contacts":132},"Sun Yat-sen University Cancer Center","Guangzhou","Guangdong","510060",{"type":101,"coordinates":128},[129,130],113.25,23.11667,{"lat":130,"lon":129},[133],{"name":134,"role":86,"phone":135,"phoneExt":37,"email":136},"Qingqing Cai, M.D.","+862087342823","caiqq@sysucc.org.cn",{"type":138,"investigatorFullName":37,"investigatorTitle":37,"investigatorAffiliation":37,"oldNameTitle":37,"oldOrganization":37},"SPONSOR","100438777",false,"NCT04993690","A Study of LP-168 in Participants With Relapse or Refractory B-Cell Lymphoma","A Phase 1 Open-Label Dose Escalation and Expansion Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of LP-168 in Adult Patients With Relapse or Refractory B-Cell Lymphoma","Key Inclusion Criteria:\n\n* Per 2017 revised WHO lymphoma classification criteria, subject must have either:\n\nDiagnosed with relapsed or refractory DLBCL or FL and require treatment in the opinion of the Investigator and have received 2 lines SOC.\n\nDiagnosed with relapsed or refractory non-Hodgkin's lymphoma associated with B-cell proliferation (such as CLL\\\\ SLL \\\\ MCL \\\\ MZL \\\\ WM, etc.) in need of treatment in the opinion of the Investigator and have received 1 line SOC.\n\n* Adequate hematologic function.\n* Adequate hepatic and renal function.\n* Ability to receive study drug therapy orally and willing to receive examinations.\n* Willingness of men and women of reproductive potential (defined as following menarche and not postmenopausal \\[and 2 years of non-therapy-induced amenorrhea\\] or surgically sterile) to observe conventional and effective birth control.\n\nKey Exclusion Criteria:\n\n* According to the 2017 revised WHO Lymphoma Classification Criteria, patients diagnosed with the following diseases: Burkitt lymphoma or Burkitt-like lymphoma, lymphoblastic lymphoma\u002Fleukemia, and post-transplant lymphoproliferative disease(PTLD).\n* Prior malignancy (other than the disease under study) within the past 3 years, except for curatively treated basal or squamous cell skin cancer, carcinoma in situ of the cervix or breast cancer.\n* Subjects who have received the following treatments within 4 weeks or 5 half-lives before the first dose of LP-168:\n\nAntitumor therapies including myelosuppressive chemotherapy, targeted therapy, biological therapy and\u002For immunotherapy; Any investigational treatment; Patients who have undergone major surgery, severe trauma or radiotherapy.\n\n* Subjects who have received the following treatments within 2 weeks before the first dose of LP-168:\n\nSteroids or traditional herbal medicine for antitumor purposes; Strong and moderate CYP3A inhibitors and inducers; All drugs that may cause QTc interval prolongation or torsional tachycardia.\n\n* Disease states where clinical manifestations may be difficult to control, including HIV, HBV, HCV, syphilis positive or active bacterial and fungal infections; Disease affects the central nervous system with obvious symptoms; Autoimmune hemolytic anemia or Idiopathic thrombocytopenic purpura. Any gastrointestinal conditions that may severely affect the study drug absorption or pharmacokinetic parameters.\n* Subjects who cannot tolerate urine collection, venipuncture, lymph node biopsy, and bone marrow aspiration.","ALL","18 Years","80 Years",{"count":149,"type":150},200,"ESTIMATED","INTERVENTIONAL",[153],"PHASE1","This is an open-label, multi-center Phase 1\u002F2 study of oral LP-168 in patients with CLL\u002FSLL and NHL who have failed or are intolerant to standard of care.",[156],"B-cell Lymphoma","2025-09-18",{"date":159,"type":160},"2025-09-23","ACTUAL",{"date":162,"type":160},"2021-07-06",{"date":164,"type":150},"2027-06-30",{"name":5,"class":6},3]