[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100570466":3},{"organization":4,"outcomesModule":7,"designInfo":51,"detailedDescription":50,"studyPopulation":50,"armGroups":57,"interventions":64,"overallOfficials":50,"centralContacts":70,"locations":76,"responsibleParty":142,"collaborators":50,"id":144,"slug":50,"hasResults":145,"nctId":146,"briefTitle":147,"officialTitle":148,"acronym":50,"eligibilityCriteria":149,"healthyVolunteers":145,"sex":150,"minAge":151,"maxAge":152,"enrollmentInfo":153,"targetDuration":50,"studyType":156,"phases":157,"briefSummary":159,"conditions":160,"keywords":163,"overallStatus":79,"whyStopped":50,"lastUpdateSubmitDate":165,"lastUpdatePostDateStruct":166,"startDateStruct":169,"completionDateStruct":171,"leadSponsor":173,"locationsCount":174},{"fullName":5,"class":6},"Shanghai Allink Biotherapeutics Co., Ltd.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":50},[9],{"measure":10,"description":11,"timeFrame":12},"To evaluate the safety and tolerability of ALK202 in adult participants with advanced solid tumors; To determine the maximum tolerated dose (MTD); To determine the recommended dose(s) of ALK202 for subsequent clinical studies.","Dose-limiting toxicity (DLT); The incidence and severity of treatment-emergent adverse events (TEAEs) and treatment-related adverse events (TRAEs) according to CTCAE v5.0.","Approximately 36 months",[14,17,19,21,23,25,27,29,31,33,36,39,41,43,45,47],{"measure":15,"description":16,"timeFrame":12},"To evaluate the pharmacokinetics (PK) of ALK202","PK parameters after single and multiple doses: area under the concentration-time curve from time zero to the last measurement (AUC0-last)",{"measure":15,"description":18,"timeFrame":12},"PK parameters after single and multiple doses: area under the concentration-time curve from time zero to infinity (AUC0-inf)",{"measure":15,"description":20,"timeFrame":12},"PK parameters after single and multiple doses: Maximum serum Concentration (Cmax)",{"measure":15,"description":22,"timeFrame":12},"PK parameters after single and multiple doses: Time to Maximum Concentration(Tmax)",{"measure":15,"description":24,"timeFrame":12},"PK parameters after single and multiple doses: trough Concentration(Ctrough)",{"measure":15,"description":26,"timeFrame":12},"PK parameters after single and multiple doses: Clearance(CL)",{"measure":15,"description":28,"timeFrame":12},"PK parameters after single and multiple doses: apparent Distribution Volume(Vd)",{"measure":15,"description":30,"timeFrame":12},"PK parameters after single and multiple doses: steady-state apparent distribution volume (Vss)",{"measure":15,"description":32,"timeFrame":12},"PK parameters after single and multiple doses: terminal half-life (t1\u002F2)",{"measure":34,"description":35,"timeFrame":12},"To evaluate the immunogenicity of ALK202","The generation of anti-drug antibodies (ADAs)",{"measure":37,"description":38,"timeFrame":12},"To evaluate the preliminary antitumor activity of ALK202","Objective Response Rate (ORR)",{"measure":37,"description":40,"timeFrame":12},"Duration of Response (DOR)",{"measure":37,"description":42,"timeFrame":12},"Disease Control Rate (DCR)",{"measure":37,"description":44,"timeFrame":12},"Progression-Free Survival (PFS)",{"measure":37,"description":46,"timeFrame":12},"Overall Survival (OS)",{"measure":48,"description":49,"timeFrame":12},"To evaluate the biomarkers","To explore the correlation between biomarkers (EGFR\u002Fc-MET) and the efficacy and other clinical outcomes\u002Fparameters of ALK202",null,{"allocation":52,"interventionModel":53,"interventionModelDescription":50,"primaryPurpose":54,"observationalModel":50,"timePerspective":50,"maskingInfo":55},"NA","SEQUENTIAL","TREATMENT",{"masking":56,"maskingDescription":50,"whoMasked":50},"NONE",[58],{"label":59,"type":60,"description":61,"interventionNames":62},"Part A: Dose-escalation Phase Part B: Dose-expansion Phase","EXPERIMENTAL","A dose-escalation study to determine the MTD and the subsequent doses for dose expansion study (Part B). A dose-expansion study which will enroll the select indications.",[63],"Drug: ALK202",[65],{"type":66,"name":67,"description":68,"armGroupLabels":69,"otherNames":50},"DRUG","ALK202","Administered intravenously, once every 3 weeks",[59],[71],{"name":72,"role":73,"phone":74,"phoneExt":50,"email":75},"Shuntong Duan","CONTACT","8618005141727","stduan@allinkbio.com",[77,96,111,128],{"facility":78,"status":79,"city":80,"state":81,"zip":82,"country":83,"countryCode":84,"cosmosGeoPoint":85,"geoPoint":90,"contacts":91},"D&H Cancer Research Center Llc","RECRUITING","Margate","Florida","33063","United States","US",{"type":86,"coordinates":87},"Point",[88,89],-80.20644,26.24453,{"lat":89,"lon":88},[92],{"name":93,"role":73,"phone":94,"phoneExt":50,"email":95},"Dr. David Kahn","+1 9543232422","Drdkahn@dhnrc.com",{"facility":97,"status":79,"city":98,"state":99,"zip":100,"country":83,"countryCode":84,"cosmosGeoPoint":101,"geoPoint":105,"contacts":106},"Next Oncology","Fairfax","Virginia","22031",{"type":86,"coordinates":102},[103,104],-77.30637,38.84622,{"lat":104,"lon":103},[107],{"name":108,"role":73,"phone":109,"phoneExt":50,"email":110},"Dr. Alex Apira","+1 7032805390","aspira@nextoncology.com",{"facility":112,"status":79,"city":113,"state":114,"zip":115,"country":116,"countryCode":117,"cosmosGeoPoint":118,"geoPoint":122,"contacts":123},"Scientia Clinical Research Ltd","Randwick","New South Wales","2031","Australia","AU",{"type":86,"coordinates":119},[120,121],151.24895,-33.91439,{"lat":121,"lon":120},[124],{"name":125,"role":73,"phone":126,"phoneExt":50,"email":127},"Dr. Charlotte Lemech","+61 2 93825807","Charlotte.lemech@scientiaclinicalresearch.com.au",{"facility":129,"status":79,"city":130,"state":114,"zip":131,"country":116,"countryCode":117,"cosmosGeoPoint":132,"geoPoint":136,"contacts":137},"Macquarie University","Sydney","2109",{"type":86,"coordinates":133},[134,135],151.20732,-33.86785,{"lat":135,"lon":134},[138],{"name":139,"role":73,"phone":140,"phoneExt":50,"email":141},"Dr. John Park","+61 2 98123000","John.park@mqhealth.org.au",{"type":143,"investigatorFullName":50,"investigatorTitle":50,"investigatorAffiliation":50,"oldNameTitle":50,"oldOrganization":50},"SPONSOR","100570466",false,"NCT06707610","A Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK), and Antitumor Activity of ALK202 in Participants with Advanced Solid Tumors","A First-in-Human, Open-Label, Multi-Center Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of ALK202 for Injection in Adult Participants with Advanced Solid Tumors","Inclusion Criteria:\n\n* Men and women ≥18 and ≤75 years old on the day of signing the ICF\n* At least 1 measurable lesion per RECIST v1.1\n* Expected survival ≥3 months\n* ECOG PS score of 0 or 1\n* Adequate organ function\n* Female participants of childbearing potential or male participants whose partner is a female of childbearing potential agree to use medically effective contraceptive methods (abstinence, birth control pills, barrier contraception, intra-uterine contraceptive device, etc.) from the date of signing the ICF until at least 6 months after the last dose of ALK202, and during this period, male participants are not allowed to donate sperms.\n\nExclusion Criteria:\n\n* Received organ transplant or hematopoietic stem cell transplant previously\n* Vaccinated with live vaccines within 4 weeks prior to the first dose\n* Primary central nervous system malignancies, or active metastases to central nervous system and\u002For metastases to meninges\n* Pregnant or lactating women\n* Pleural effusion, pericardial effusion, or intraperitoneal effusion accompanied with clinical symptoms, clinically poorly controlled, or requiring repeated drainage.\n* Evidence of other severe or uncontrolled systemic diseases (e.g., decompensated respiratory disorder, hepatic disease, or renal disease).\n\nNote: Other protocol defined Inclusion\u002FExclusion criteria may apply.","ALL","18 Years","75 Years",{"count":154,"type":155},234,"ESTIMATED","INTERVENTIONAL",[158],"PHASE1","TThis is a first-in-human (FIH), open-label, multicenter dose escalation and expansion study of ALK202. The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and antitumor activity of ALK202 as a monotherapy in adult participants with Advanced Solid Tumors. The study will also identify recommended dose(s) for subsequent clinical studies of ALK202.",[161,162],"Advanced Cancer","Advanced Solid Tumor",[164],"First-in-human","2025-03-09",{"date":167,"type":168},"2025-03-12","ACTUAL",{"date":170,"type":168},"2025-02-10",{"date":172,"type":155},"2028-12",{"name":5,"class":6},4]