[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100438777":3},{"organization":4,"armGroups":7,"interventions":34,"overallOfficials":41,"centralContacts":46,"locations":54,"responsibleParty":100,"collaborators":40,"id":102,"slug":103,"hasResults":104,"nctId":105,"briefTitle":106,"officialTitle":107,"acronym":40,"eligibilityCriteria":108,"healthyVolunteers":104,"sex":109,"minAge":110,"maxAge":111,"enrollmentInfo":112,"targetDuration":40,"studyType":115,"phases":116,"briefSummary":118,"conditions":119,"keywords":40,"overallStatus":57,"whyStopped":40,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":122,"startDateStruct":125,"completionDateStruct":127,"leadSponsor":129,"locationsCount":130},{"fullName":5,"class":6},"Guangzhou Lupeng Pharmaceutical Company LTD.","INDUSTRY",[8,14,18,22,26,30],{"label":9,"type":10,"description":11,"interventionNames":12},"Phase I Dose Escalation","EXPERIMENTAL","Dose Escalation and determination of MTD; multiple dose levels of LP-168 to be evaluated",[13],"Drug: LP-168 tablet",{"label":15,"type":10,"description":16,"interventionNames":17},"Phase I Dose Expansion A","CLL\u002FSLL patients treated with prior regimens.",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"Phase I Dose Expansion B","CLL\u002FSLL patients with no prior therapy.",[13],{"label":23,"type":10,"description":24,"interventionNames":25},"Phase I Dose Expansion C","MCL patients treated with prior regimens.",[13],{"label":27,"type":10,"description":28,"interventionNames":29},"Phase I Dose Expansion D","WM patients treated with prior regimens.",[13],{"label":31,"type":10,"description":32,"interventionNames":33},"Phase I Dose Expansion E","MZL patients treated with prior regimens.",[13],[35],{"type":36,"name":37,"description":38,"armGroupLabels":39,"otherNames":40},"DRUG","LP-168 tablet","Subjects to take LP-168 orally with 240mL water, without food, Once daily or twice daily",[9,15,19,23,27,31],null,[42],{"name":43,"affiliation":44,"role":45},"Jun Zhu","Peking University Cancer Hospital & Institute","STUDY_CHAIR",[47,52],{"name":48,"role":49,"phone":50,"phoneExt":40,"email":51},"Jun Zhu, MD, PhD","CONTACT","+86-010-88196596","zj@bjcancer.org",{"name":53,"role":49,"phone":40,"phoneExt":40,"email":40},"Yuqin Song, MD, PhD",[55,74,85],{"facility":56,"status":57,"city":58,"state":59,"zip":60,"country":61,"countryCode":62,"cosmosGeoPoint":63,"geoPoint":68,"contacts":69},"Peking University Third Hospital","RECRUITING","Beijing","Beijing Municipality","100089","China","CN",{"type":64,"coordinates":65},"Point",[66,67],116.39723,39.9075,{"lat":67,"lon":66},[70],{"name":71,"role":49,"phone":72,"phoneExt":40,"email":73},"Hongmei Jing, M.D.","+861082265531","hongmei_jing@163.com",{"facility":75,"status":57,"city":58,"state":59,"zip":76,"country":61,"countryCode":62,"cosmosGeoPoint":77,"geoPoint":79,"contacts":80},"Beijing Cancer Hospital","100142",{"type":64,"coordinates":78},[66,67],{"lat":67,"lon":66},[81],{"name":82,"role":49,"phone":83,"phoneExt":40,"email":84},"Yuqin Song","+861088196596","SongYQ_VIP@163.com",{"facility":86,"status":57,"city":87,"state":88,"zip":89,"country":61,"countryCode":62,"cosmosGeoPoint":90,"geoPoint":94,"contacts":95},"Sun Yat-sen University Cancer Center","Guangzhou","Guangdong","510060",{"type":64,"coordinates":91},[92,93],113.25,23.11667,{"lat":93,"lon":92},[96],{"name":97,"role":49,"phone":98,"phoneExt":40,"email":99},"Qingqing Cai, M.D.","+862087342823","caiqq@sysucc.org.cn",{"type":101,"investigatorFullName":40,"investigatorTitle":40,"investigatorAffiliation":40,"oldNameTitle":40,"oldOrganization":40},"SPONSOR","100438777","phase-1-a-study-of-lp-168-in-participants-with-relapse-or-refractory-b-cell-lymphoma-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":113,"type":114},200,"ESTIMATED","INTERVENTIONAL",[117],"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.",[120],"B-cell Lymphoma","2025-09-18",{"date":123,"type":124},"2025-09-23","ACTUAL",{"date":126,"type":124},"2021-07-06",{"date":128,"type":114},"2027-06-30",{"name":5,"class":6},3]