[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100610489":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":24,"centralContacts":24,"locations":28,"responsibleParty":239,"collaborators":24,"id":241,"slug":242,"hasResults":243,"nctId":244,"briefTitle":245,"officialTitle":246,"acronym":24,"eligibilityCriteria":247,"healthyVolunteers":243,"sex":248,"minAge":249,"maxAge":24,"enrollmentInfo":250,"targetDuration":24,"studyType":253,"phases":254,"briefSummary":257,"conditions":258,"keywords":24,"overallStatus":31,"whyStopped":24,"lastUpdateSubmitDate":260,"lastUpdatePostDateStruct":261,"startDateStruct":264,"completionDateStruct":266,"leadSponsor":268,"locationsCount":269},{"fullName":5,"class":6},"Hutchmed","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Part A(Phase I)","EXPERIMENTAL","Dose Escalation",[13],"Drug: HMPL-A251",{"label":15,"type":10,"description":16,"interventionNames":17},"Part B(Phase IIa)","Dose Expansion\u002FDose Optimization",[13],[19,25],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"DRUG","HMPL-A251","Six dose cohorts are planned for the Dose Escalation phase; at least three participants with solid tumors will be enrolled in each dose cohort. Bayesian optimal interval design with backfill (BF-BOIN, Zhao, 2023) will be used to guide dose escalation and determine the MTD and\u002For RDE of HMPL-A251. All study participants will receive HMPL-A251 as IV infusion until PD, intolerable toxicity, or other protocol-specified criteria for ending study treatment, whichever occurs first.",[9],null,{"type":20,"name":21,"description":26,"armGroupLabels":27,"otherNames":24},"Participants will be randomized in a 1:1 ratio to receive treatment in two RDEs levels (approximately 15 participants per dose level) for each cohort. All study participants will receive HMPL-A251 as IV infusion until PD, intolerable toxicity, or other protocol-specified criteria for ending study treatment, whichever occurs first.",[15],[29,49,64,72,84,97,109,124,137,150,165,178,191,204,215,226],{"facility":30,"status":31,"city":32,"state":33,"zip":34,"country":35,"countryCode":36,"cosmosGeoPoint":37,"geoPoint":42,"contacts":43},"SCRI HealthONE","RECRUITING","Denver","Colorado","80218","United States","US",{"type":38,"coordinates":39},"Point",[40,41],-104.9847,39.73915,{"lat":41,"lon":40},[44],{"name":45,"role":46,"phone":47,"phoneExt":24,"email":48},"Gerald Falchook","CONTACT","940-365-6217","bianca.reyes@scri.com",{"facility":50,"status":31,"city":51,"state":52,"zip":53,"country":35,"countryCode":36,"cosmosGeoPoint":54,"geoPoint":58,"contacts":59},"BRCR 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Wu",{"facility":216,"status":66,"city":217,"state":24,"zip":24,"country":153,"countryCode":154,"cosmosGeoPoint":218,"geoPoint":222,"contacts":223},"The First Hospital of China Medical University","Shenyang",{"type":38,"coordinates":219},[220,221],123.43278,41.79222,{"lat":221,"lon":220},[224],{"name":225,"role":46,"phone":24,"phoneExt":24,"email":24},"Funan Liu",{"facility":227,"status":31,"city":228,"state":24,"zip":24,"country":153,"countryCode":154,"cosmosGeoPoint":229,"geoPoint":233,"contacts":234},"Henan Cancer Hospital","Zhengzhou",{"type":38,"coordinates":230},[231,232],113.64861,34.75778,{"lat":232,"lon":231},[235],{"name":236,"role":46,"phone":237,"phoneExt":24,"email":238},"Min Yan","+86 157 1385 7388","ym200678@163.com",{"type":240,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR","100610489","phase-1-a-phase-a-study-of-hmpl-a251-in-participants-with-advanced-or-metastatic-her2-expressing-solid-tumors-100610489",false,"NCT07228247","A Phase Ⅰ\u002FⅡa Study of HMPL-A251 in Participants With Advanced or Metastatic HER2-expressing Solid Tumors","A Phase Ⅰ\u002FⅡa Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity and Preliminary Efficacy of HMPL-A251 in Participants With Advanced or Metastatic HER2-Expressing Solid Tumors","Inclusion Criteria:\n\n1. Histologically confirmed unresectable advanced or metastatic disease.\n2. Have at least one measurable lesion per RECIST v1.1;\n3. Life expectancy ≥ 12 weeks;\n4. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-1;\n5. Weight ≥ 35 kg;\n\nExclusion Criteria:\n\n1. An established diagnosis of type I diabetes mellitus or uncontrolled type II diabetes mellitus.\n2. Use of strong inhibitors of cytochrome P450 3A4 enzyme (CYP3A4), and inhibitors of P-glycoprotein (P-gp) and breast cancer resistance protein (BCRP) within 5 elimination half-lives or 2 weeks (whichever is longer) before the first dose of study drug;\n3. Toxicity from prior anti-tumor therapy has not recovered to Grade 1 or baseline prior to the first dose of study drug (except alopecia). Participants with chronic Grade 2 toxicities may be eligible after discussion between the investigator and Sponsor Medical Monitor (e.g., Grade 2 chemotherapy-induced neuropathy);\n4. Baseline blood amylase or lipase exceeds the normal range and are judged by the investigators to be clinically significant;\n5. Spinal cord compression, leptomeningeal disease, or clinically active central nervous system (CNS) metastases, defined as untreated or symptomatic, or requiring therapy with corticosteroids or anticonvulsants to control associated symptoms;\n6. Major surgery within 28 days prior to the first dose of study drug. Participants must have recovered adequately from the toxicity and\u002For complications from the intervention prior to the first dose of study drug(s);","ALL","18 Years",{"count":251,"type":252},147,"ESTIMATED","INTERVENTIONAL",[255,256],"PHASE1","PHASE2","This is a first-in-human (FIH), phase Ⅰ\u002FⅡa, open-label, multicenter clinical study of HMPL-A251 monotherapy in adult participants with unresectable, advanced or metastatic HER2-expressing solid tumors.",[259],"Solid Tumors, Adult","2026-05-25",{"date":262,"type":263},"2026-05-27","ACTUAL",{"date":265,"type":263},"2025-12-16",{"date":267,"type":252},"2028-12-31",{"name":5,"class":6},16]