[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100545764":3},{"organization":4,"outcomesModule":7,"designInfo":34,"detailedDescription":40,"studyPopulation":33,"armGroups":41,"interventions":52,"overallOfficials":33,"centralContacts":60,"locations":66,"responsibleParty":202,"collaborators":33,"id":204,"slug":33,"hasResults":205,"nctId":206,"briefTitle":207,"officialTitle":208,"acronym":33,"eligibilityCriteria":209,"healthyVolunteers":205,"sex":210,"minAge":211,"maxAge":33,"enrollmentInfo":212,"targetDuration":33,"studyType":215,"phases":216,"briefSummary":219,"conditions":220,"keywords":222,"overallStatus":69,"whyStopped":33,"lastUpdateSubmitDate":224,"lastUpdatePostDateStruct":225,"startDateStruct":228,"completionDateStruct":230,"leadSponsor":232,"locationsCount":233},{"fullName":5,"class":6},"Jacobio Pharmaceuticals Co., Ltd.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":17,"otherOutcomes":33},[9,13],{"measure":10,"description":11,"timeFrame":12},"Dose limiting toxicity (DLT)","Number and proportion of participants who experience at least one dose limiting toxicity (DLT)","Approximately one year",{"measure":14,"description":15,"timeFrame":16},"Number of participants with adverse events","All patients participating in this study will be assessed for incidence and severity of adverse events (AEs) and serious AEs, including changes in laboratory values, vital signs, electrocardiograms et al.","Approximately three years",[18,21,24,27,30],{"measure":19,"description":20,"timeFrame":16},"Peak Plasma Concentration (Cmax)","Observed maximum plasma concentration after administration. Plasma concentrations of JAB-30355 from subjects will be used to calculate PK parameters.",{"measure":22,"description":23,"timeFrame":16},"Time to reach the observed maximum (peak) concentration (Tmax)","Time to reach the observed maximum (peak) concentration. Plasma concentrations of JAB-30355 from subjects will be used to calculate PK parameters.",{"measure":25,"description":26,"timeFrame":16},"Terminal half-life (t1\u002F2)","Terminal half-life of JAB-30355 in human. Plasma concentrations of JAB-30355 from subjects will be used to calculate PK parameters.",{"measure":28,"description":29,"timeFrame":16},"Objective response rate (ORR)","ORR is defined as the percentage of participants with partial response (PR) or complete response (CR) based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.",{"measure":31,"description":32,"timeFrame":16},"Duration of response (DOR)","DOR is defined as the time from the date of the first documented response (CR or PR) to the earliest date of disease progression or death, whichever occurs first, as determined by investigator assessment per RECIST v1.1.",null,{"allocation":35,"interventionModel":36,"interventionModelDescription":33,"primaryPurpose":37,"observationalModel":33,"timePerspective":33,"maskingInfo":38},"NON_RANDOMIZED","SEQUENTIAL","TREATMENT",{"masking":39,"maskingDescription":33,"whoMasked":33},"NONE","This study consists of two parts: Dose Escalation Phase (Phase 1) and Dose Expansion Phase (Phase 2a). The primary objective of dose escalation is to evaluate the safety and tolerability, and to determine the MTD of JAB-30355 monotherapy administered in participants with advanced solid tumors harboring TP53 Y220C mutation. Dose expansion will further explore JAB-30355's clinical benefit and tolerability in selected dose levels.",[42,48],{"label":43,"type":44,"description":45,"interventionNames":46},"Dose escalation phase","EXPERIMENTAL","Multiple dose levels of JAB-30355 will be explored to determine the maximum tolerated dose (MTD)",[47],"Drug: JAB-30355",{"label":49,"type":44,"description":50,"interventionNames":51},"Dose expansion phase","Dose Expansion Phase will explore JAB-30355's clinical benefit and optimal tolerability in selected dose level.",[47],[53,58],{"type":54,"name":55,"description":56,"armGroupLabels":57,"otherNames":33},"DRUG","JAB-30355","Oral administration",[43],{"type":54,"name":55,"description":56,"armGroupLabels":59,"otherNames":33},[49],[61],{"name":62,"role":63,"phone":64,"phoneExt":33,"email":65},"Jacobio Pharmaceuticals","CONTACT","781-918-6670","clinicaltrials@jacobiopharma.com",[67,81,92,101,110,118,127,136,147,152,157,166,175,184,193],{"facility":68,"status":69,"city":70,"state":71,"zip":72,"country":73,"countryCode":74,"cosmosGeoPoint":75,"geoPoint":80,"contacts":33},"Research Site","RECRUITING","Denver","Colorado","80218","United States","US",{"type":76,"coordinates":77},"Point",[78,79],-104.9847,39.73915,{"lat":79,"lon":78},{"facility":82,"status":83,"city":84,"state":85,"zip":86,"country":73,"countryCode":74,"cosmosGeoPoint":87,"geoPoint":91,"contacts":33},"Research site","TERMINATED","Lake Mary","Florida","32771",{"type":76,"coordinates":88},[89,90],-81.31784,28.75888,{"lat":90,"lon":89},{"facility":82,"status":69,"city":93,"state":94,"zip":95,"country":73,"countryCode":74,"cosmosGeoPoint":96,"geoPoint":100,"contacts":33},"St 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Municipality","100000","China","CN",{"type":76,"coordinates":143},[144,145],116.39723,39.9075,{"lat":145,"lon":144},{"facility":68,"status":69,"city":137,"state":138,"zip":148,"country":140,"countryCode":141,"cosmosGeoPoint":149,"geoPoint":151,"contacts":33},"100021",{"type":76,"coordinates":150},[144,145],{"lat":145,"lon":144},{"facility":68,"status":69,"city":137,"state":138,"zip":153,"country":140,"countryCode":141,"cosmosGeoPoint":154,"geoPoint":156,"contacts":33},"100142",{"type":76,"coordinates":155},[144,145],{"lat":145,"lon":144},{"facility":68,"status":69,"city":158,"state":159,"zip":160,"country":140,"countryCode":141,"cosmosGeoPoint":161,"geoPoint":165,"contacts":33},"Guangzhou","Guangdong","510000",{"type":76,"coordinates":162},[163,164],113.25,23.11667,{"lat":164,"lon":163},{"facility":68,"status":69,"city":167,"state":168,"zip":169,"country":140,"countryCode":141,"cosmosGeoPoint":170,"geoPoint":174,"contacts":33},"Zhengzhou","Henan","451191",{"type":76,"coordinates":171},[172,173],113.64861,34.75778,{"lat":173,"lon":172},{"facility":68,"status":69,"city":176,"state":177,"zip":178,"country":140,"countryCode":141,"cosmosGeoPoint":179,"geoPoint":183,"contacts":33},"Shenyang","Liaoning","110801",{"type":76,"coordinates":180},[181,182],123.43278,41.79222,{"lat":182,"lon":181},{"facility":68,"status":69,"city":185,"state":186,"zip":187,"country":140,"countryCode":141,"cosmosGeoPoint":188,"geoPoint":192,"contacts":33},"Jinan","Shandong","250117",{"type":76,"coordinates":189},[190,191],116.99722,36.66833,{"lat":191,"lon":190},{"facility":68,"status":69,"city":194,"state":195,"zip":196,"country":140,"countryCode":141,"cosmosGeoPoint":197,"geoPoint":201,"contacts":33},"Shanghai","Shanghai Municipality","200032",{"type":76,"coordinates":198},[199,200],121.45806,31.22222,{"lat":200,"lon":199},{"type":203,"investigatorFullName":33,"investigatorTitle":33,"investigatorAffiliation":33,"oldNameTitle":33,"oldOrganization":33},"SPONSOR","100545764",false,"NCT06386146","JAB-30355 in Patients With Advanced Solid Tumors Harboring TP53 Y220C Mutation","A Phase 1\u002F2a, Multi-Center, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Evidence of Antitumor Activity of JAB-30355 in Adult Patients With Advanced Solid Tumors Harboring TP53 Y220C Mutation","Inclusion Criteria:\n\n* Written informed consent.\n* Participant must be ≥18 years of age at the time of signing the Informed Consent Form (ICF).\n* ECOG performance status score of 0 or 1.\n* Has been treated with at least one line of systemic therapy for that tumor type and stage.\n* Have documentation of confirmed TP53 Y220C mutation.\n* At least 1 measurable lesion per RECIST v1.1.\n* Adequate hematological, renal and hepatic function and appropriate coagulation condition.\n* Able to swallow and retain orally administered medication.\n\nExclusion Criteria:\n\n* Active brain or spinal metastases or primary CNS tumor.\n* Active infection requiring systemic treatment within 7 days.\n* Active HBV or HCV.\n* Any severe and\u002For uncontrolled medical conditions.\n* LVEF ≤50% assessed by ECHO or MUGA.\n* QTcF \\> 470 msec.","ALL","18 Years",{"count":213,"type":214},144,"ESTIMATED","INTERVENTIONAL",[217,218],"PHASE1","PHASE2","This study is to evaluate the efficacy and safety of JAB-30355 in adult participants with advanced solid tumors harboring TP53 Y220C mutation.",[221],"Solid Tumors",[223],"TP53 Y220C reactivator; TP53 Y220C mutation; P53; Tumor protein p53; TP53; Advanced solid tumors; Ovarian Cancer; JAB-30355","2026-05-20",{"date":226,"type":227},"2026-05-22","ACTUAL",{"date":229,"type":227},"2024-07-24",{"date":231,"type":214},"2027-07",{"name":5,"class":6},15]