[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100570466":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":21,"locations":27,"responsibleParty":93,"collaborators":20,"id":95,"slug":96,"hasResults":97,"nctId":98,"briefTitle":99,"officialTitle":100,"acronym":20,"eligibilityCriteria":101,"healthyVolunteers":97,"sex":102,"minAge":103,"maxAge":104,"enrollmentInfo":105,"targetDuration":20,"studyType":108,"phases":109,"briefSummary":111,"conditions":112,"keywords":115,"overallStatus":30,"whyStopped":20,"lastUpdateSubmitDate":117,"lastUpdatePostDateStruct":118,"startDateStruct":121,"completionDateStruct":123,"leadSponsor":125,"locationsCount":126},{"fullName":5,"class":6},"Shanghai Allink Biotherapeutics Co., Ltd.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"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.",[13],"Drug: ALK202",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","ALK202","Administered intravenously, once every 3 weeks",[9],null,[22],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},"Shuntong Duan","CONTACT","8618005141727","stduan@allinkbio.com",[28,47,62,79],{"facility":29,"status":30,"city":31,"state":32,"zip":33,"country":34,"countryCode":35,"cosmosGeoPoint":36,"geoPoint":41,"contacts":42},"D&H Cancer Research Center Llc","RECRUITING","Margate","Florida","33063","United States","US",{"type":37,"coordinates":38},"Point",[39,40],-80.20644,26.24453,{"lat":40,"lon":39},[43],{"name":44,"role":24,"phone":45,"phoneExt":20,"email":46},"Dr. David Kahn","+1 9543232422","Drdkahn@dhnrc.com",{"facility":48,"status":30,"city":49,"state":50,"zip":51,"country":34,"countryCode":35,"cosmosGeoPoint":52,"geoPoint":56,"contacts":57},"Next Oncology","Fairfax","Virginia","22031",{"type":37,"coordinates":53},[54,55],-77.30637,38.84622,{"lat":55,"lon":54},[58],{"name":59,"role":24,"phone":60,"phoneExt":20,"email":61},"Dr. Alex Apira","+1 7032805390","aspira@nextoncology.com",{"facility":63,"status":30,"city":64,"state":65,"zip":66,"country":67,"countryCode":68,"cosmosGeoPoint":69,"geoPoint":73,"contacts":74},"Scientia Clinical Research Ltd","Randwick","New South Wales","2031","Australia","AU",{"type":37,"coordinates":70},[71,72],151.24895,-33.91439,{"lat":72,"lon":71},[75],{"name":76,"role":24,"phone":77,"phoneExt":20,"email":78},"Dr. Charlotte Lemech","+61 2 93825807","Charlotte.lemech@scientiaclinicalresearch.com.au",{"facility":80,"status":30,"city":81,"state":65,"zip":82,"country":67,"countryCode":68,"cosmosGeoPoint":83,"geoPoint":87,"contacts":88},"Macquarie University","Sydney","2109",{"type":37,"coordinates":84},[85,86],151.20732,-33.86785,{"lat":86,"lon":85},[89],{"name":90,"role":24,"phone":91,"phoneExt":20,"email":92},"Dr. John Park","+61 2 98123000","John.park@mqhealth.org.au",{"type":94,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100570466","phase-1-a-study-to-evaluate-the-safety-tolerability-pharmacokinetics-pk-and-antitumor-activity-of-alk202-in-participants-with-advanced-solid-tumors-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":106,"type":107},234,"ESTIMATED","INTERVENTIONAL",[110],"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.",[113,114],"Advanced Cancer","Advanced Solid Tumor",[116],"First-in-human","2025-03-09",{"date":119,"type":120},"2025-03-12","ACTUAL",{"date":122,"type":120},"2025-02-10",{"date":124,"type":107},"2028-12",{"name":5,"class":6},4]