[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100422047":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":24,"centralContacts":28,"locations":37,"responsibleParty":81,"collaborators":24,"id":83,"slug":84,"hasResults":85,"nctId":86,"briefTitle":87,"officialTitle":88,"acronym":24,"eligibilityCriteria":89,"healthyVolunteers":85,"sex":90,"minAge":91,"maxAge":24,"enrollmentInfo":92,"targetDuration":24,"studyType":95,"phases":96,"briefSummary":98,"conditions":99,"keywords":24,"overallStatus":40,"whyStopped":24,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":111,"completionDateStruct":113,"leadSponsor":115,"locationsCount":116},{"fullName":5,"class":6},"Newave Pharmaceutical Inc","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Dose Escalation Phase","EXPERIMENTAL","Three to six subjects per treatment cohort will be assigned to receive sequentially higher oral doses of LP-168 on a once or twice daily schedule for 28 days, starting at a dose of 100 mg\u002Fday.",[13],"Drug: LP-168",{"label":15,"type":10,"description":16,"interventionNames":17},"Dose Expansion Phase","Additional subjects will be recruited to further explore the safety, tolerability, PK, and efficacy in specific subject subgroups.",[13],[19,25],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"DRUG","LP-168","For the dose escalation phase, LP-168 will be given once or twice daily at the following dose levels:100 mg QD,150 mg QD, 100 mg BID, 300 mg QD, 150 mg BID, 450 mg QD, 225 mg BID, 600 mg QD, 800 mg QD, and 1000 mg QD.",[9],null,{"type":20,"name":21,"description":26,"armGroupLabels":27,"otherNames":24},"For the dose expansion phase, subjects will receive once or twice daily dose of LP-168 at the Recommended Phase 2 Dose (RP2D). The RP2D may be as high as the MTD and will be determined following evaluation of Phase I Dose Escalation results.",[15],[29,34],{"name":30,"role":31,"phone":32,"phoneExt":24,"email":33},"Anna Chen, MD, PhD","CONTACT","(206) 335-3820","yu@newavepharma.com",{"name":35,"role":31,"phone":24,"phoneExt":24,"email":36},"Stephen Anthony, DO","s.anthony@newavepharma.com",[38,52,62,71],{"facility":39,"status":40,"city":41,"state":42,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":24},"Duke Univerisity","RECRUITING","Durham","North Carolina","27708","United States","US",{"type":47,"coordinates":48},"Point",[49,50],-78.89862,35.99403,{"lat":50,"lon":49},{"facility":53,"status":40,"city":54,"state":55,"zip":56,"country":44,"countryCode":45,"cosmosGeoPoint":57,"geoPoint":61,"contacts":24},"University of Cincinnati","Cincinnati","Ohio","45221",{"type":47,"coordinates":58},[59,60],-84.51439,39.12711,{"lat":60,"lon":59},{"facility":63,"status":40,"city":64,"state":55,"zip":65,"country":44,"countryCode":45,"cosmosGeoPoint":66,"geoPoint":70,"contacts":24},"Ohio State University","Columbus","43210",{"type":47,"coordinates":67},[68,69],-82.99879,39.96118,{"lat":69,"lon":68},{"facility":72,"status":40,"city":73,"state":74,"zip":75,"country":44,"countryCode":45,"cosmosGeoPoint":76,"geoPoint":80,"contacts":24},"Huntsman Cancer Institute, University of Utah","Salt Lake City","Utah","84112",{"type":47,"coordinates":77},[78,79],-111.89105,40.76078,{"lat":79,"lon":78},{"type":82,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR","100422047","phase-1-study-of-oral-administration-of-lp-168-in-patients-with-relapsed-or-refractory-b-cell-malignancies-100422047",false,"NCT04775745","Study of Oral Administration of LP-168 in Patients With Relapsed or Refractory B-cell Malignancies.","A Phase I, Multicenter, Open-Label, Dose-escalation Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Clinical Activity of Orally Administered LP-168 in Subjects With Relapsed or Refractory B-cell Malignancies.","Inclusion Criteria:\n\nA subject will be eligible for study participation if he\u002Fshe meets the following criteria:\n\n* Subjects are eligible with B-cell malignancies, WM, FL, MCL, MZL, DLBCL, HCL, CLL, SLL, based upon 2016 updated WHO classification. Those subjects with WM, FL, MCL, DLBCL, or HCL must have received at least 2 prior systemic therapies.\n* Low-grade B-cell lymphomas as follicular Grade 1, 2, or 3A, marginal zone or small lymphocytic lymphoma.\n* Subject must have adequate coagulation, renal, and hepatic function, per local laboratory reference ranges at Screening as follows:\n\n  * Activated partial thromboplastin time (APTT) and prothrombin time (PT) not to exceed 1.5 × ULN\n  * Calculated creatinine clearance (CrCl) ≥ 60 mL\u002Fmin using 24-hour CrCl OR Cockcroft-Gault formula.\n  * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 1.5 ×ULN; Bilirubin ≤ 1.5 × ULN (except subjects with Gilbert's Syndrome, who may have a bilirubin \\> 1.5 × ULN, per discussion between the Investigator and the Medical Monitor).\n* Subjects must have adequate bone marrow independent of growth factor support per local laboratory reference range at screening as follows:\n\n  * Absolute Neutrophil Count (ANC) ≥1000\u002FuL;\n  * An exception is for subjects with an ANC\\\u003C1000\u002FuL and bone marrow heavily infiltrated with underlying disease (approximately 60% or more) may use growth factor to achieve the ANC eligibility criteria per discussion between the Investigator and the Medical Monitor.\n  * Platelet count ≥ 50,000\u002FµL - OR - Platelet count ≥ 20,000\u002F µL if thrombocytopenia is clearly due to CLL disease under study (per Investigator discretion)\n  * Hemoglobin ≥8.0g\u002FdL, and can be achieved by transfusion\n\nExclusion Criteria:\n\nA subject will not be eligible for study participation if he\u002Fshe meets any of the following criteria.\n\n* Subject has received any of the following therapies within 14 days or 5 half-lives (whichever is shorter) prior to the first dose of study drug, or has not recovered to ≤ Grade 1 clinically significant adverse effect(s)\u002Ftoxicity(s) of the previous therapy (other than alopecia):\n\n  * Any anti-cancer therapy including chemotherapy, biologic or immunotherapy, radiotherapy, etc;\n  * Any investigational therapy, including targeted small molecule agents.\n  * For CLL subjects who come off BCR antagonists (BTK inhibitors, PI3K inhibitors, etc.) treatment, allow washout for 2 days as these subjects progress quickly after treatment discontinuation and then remain eligible (steroids may be given during these two days to allow disease control).\n* Subjects who require immediate cytoreduction. However, subjects may receive up to two days of steroids for symptoms of impending organ impairment and remain eligible.\n* Subject has received the following medications or therapies within 7 days prior to the first dose of study drug:\n\n  * Steroid therapy (at dosages equivalent to prednisone \\>20 mg\u002Fday) for anti-neoplastic intent (except as noted in exclusion criteria #3);\n  * Cytochrome P450, family 3, subfamily A (CYP3A4) strong inhibitors and strong CYP2C8 inducers\u002Finhibitors.\n  * Potent CYP3A4 inducers such as rifampin, carbamazepine, phenytoin, and St. John's wort.\n* Subjects require treatment with systemic acid-reducing agents including H-2-receptor antagonists and proton pump inhibitors with the following exceptions:\n\n  * Proton pump inhibitors should be discontinued at least 7 days prior and held throughout the study\n  * If concurrent use of an H2 blocking agent is necessary, it must be administered only between 2 and 3 hours after the dose of LP-168. If not taken during this time, the dose of H2 blocking agents should not be taken again until 2-3 hours after the next dose of LP-168.\n  * If concurrent use of a local antacid is necessary, it must be administered 2 or more hours before and\u002For 2 or more hours after the dose of LP-168.\n* Subject has significant screening electrocardiogram (ECG) abnormalities including. 2nd degree AV block type II 3rd degree block, Grade 2 or higher bradycardia, and corrected QT interval (QTc) ≥ 480ms.\n* Serum amylase \\> 1.5 × ULN or serum lipase \\> 1.5 × ULN.\n* Subject has any history of Richter's transformation for Phase 1a portion of the trial.\n* Subjects who have undergone autologous\u002Fallogeneic hematopoietic stem cell transplantation (HSCT) therapy within 90 days of the first dose of LP-168, or patients on immunosuppressive therapy post-HSCT at the time of Screening, or currently with clinically significant graft-versus-host disease (GVHD) as per treating physician (Patients in relapse after allogeneic transplantation must be off treatment with systemic immunosuppressive agents for at least 4 weeks. The use of topical steroids and\u002For up to 20 mg\u002Fday prednisone or equivalent systemic steroids for ongoing GVHD is permitted.\n* Subject has a history of other active malignancies other than B-cell malignancies within the past 3 years prior to study entry, with the exception of:\n\n  * Adequately treated in situ carcinoma of the cervix uteri;\n  * Basal cell carcinoma of the skin or localized squamous cell carcinoma of the skin;\n  * Previous malignancy confined and surgically resected (or treated with other modalities) with curative intent.\n* Subject requires anticoagulation with Warfarin.","ALL","18 Years",{"count":93,"type":94},60,"ESTIMATED","INTERVENTIONAL",[97],"PHASE1","This is a phase I, multi-center, open-label, dose-escalation study to evaluate the safety, tolerability, pharmacokinetics and clinical activity of LP-168 in subjects with relapsed or refractory B-cell malignancies. LP-168 is a small molecule inhibitor.",[100,101,102,103,104,105,106],"CLL\u002FSLL","Waldenstrom Macroglobulinemia","Follicular Lymphoma","Diffuse Large B Cell Lymphoma","Mantle Cell Lymphoma","Marginal Zone Lymphoma","Hairy Cell Leukemia","2026-02-10",{"date":109,"type":110},"2026-02-13","ACTUAL",{"date":112,"type":110},"2021-07-19",{"date":114,"type":94},"2027-12-31",{"name":5,"class":6},4]