[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100505477":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":40,"centralContacts":45,"locations":46,"responsibleParty":83,"collaborators":45,"id":85,"slug":86,"hasResults":87,"nctId":88,"briefTitle":89,"officialTitle":90,"acronym":45,"eligibilityCriteria":91,"healthyVolunteers":87,"sex":92,"minAge":93,"maxAge":94,"enrollmentInfo":95,"targetDuration":45,"studyType":98,"phases":99,"briefSummary":101,"conditions":102,"keywords":45,"overallStatus":48,"whyStopped":45,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":105,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":113},{"fullName":5,"class":6},"HighField Biopharmaceuticals Corporation","INDUSTRY",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Dose escalation: HF158K1 1.4 g lipid dose","EXPERIMENTAL","Participants in this dose group (1.4 g lipid dose) will receive HF158K1 on D1 of each treatment cycle (3 weeks as a treatment cycle) through intravenous infusion.",[13],"Drug: HF158K1 \u002F 1.4 g lipid dose",{"label":15,"type":10,"description":16,"interventionNames":17},"Dose escalation: HF158K1 2.2 g lipid dose","Participants in this dose group (2.2 g lipid dose) will receive HF158K1 on D1 of each treatment cycle (3 weeks as a treatment cycle) through intravenous infusion.",[18],"Drug: HF158K1 \u002F 2.2 g lipid dose",{"label":20,"type":10,"description":21,"interventionNames":22},"Dose escalation: HF158K1 2.9 g lipid dose","Participants in this dose group (2.9 g lipid dose) will receive HF158K1 on D1 of each treatment cycle (3 weeks as a treatment cycle) through intravenous infusion.",[23],"Drug: HF158K1 \u002F 2.9 g lipid dose",[25,32,36],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"DRUG","HF158K1 \u002F 1.4 g lipid dose","Duration of infusion: HF158K1 is diluted using 5% (50 mg\u002Fml) glucose injection or 0.9% sodium chloride injection (saline) to a total volume of 250 ml and is administered through intravenous infusion for 90 ± 10 min.",[9],[31],"Infusion",{"type":26,"name":33,"description":28,"armGroupLabels":34,"otherNames":35},"HF158K1 \u002F 2.2 g lipid dose",[15],[31],{"type":26,"name":37,"description":28,"armGroupLabels":38,"otherNames":39},"HF158K1 \u002F 2.9 g lipid dose",[20],[31],[41],{"name":42,"affiliation":43,"role":44},"MINAL BARVE","Mary Crowley Cancer Research","PRINCIPAL_INVESTIGATOR",null,[47,65],{"facility":43,"status":48,"city":49,"state":50,"zip":51,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":60},"RECRUITING","Dallas","Texas","75241","United States","US",{"type":55,"coordinates":56},"Point",[57,58],-96.80667,32.78306,{"lat":58,"lon":57},[61],{"name":42,"role":62,"phone":63,"phoneExt":45,"email":64},"CONTACT","972-566-3000","MBarve@MaryCrowley.org",{"facility":66,"status":48,"city":67,"state":68,"zip":69,"country":70,"countryCode":71,"cosmosGeoPoint":72,"geoPoint":76,"contacts":77},"Sun Yat-sen University Cancer Center","Guangzhou","Guangdong","510060","China","CN",{"type":55,"coordinates":73},[74,75],113.25,23.11667,{"lat":75,"lon":74},[78,81],{"name":79,"role":62,"phone":45,"phoneExt":45,"email":80},"Kai Yao, PhD","yaokai@sysucc.org.cn",{"name":82,"role":44,"phone":45,"phoneExt":45,"email":45},"Kai Yao",{"type":84,"investigatorFullName":45,"investigatorTitle":45,"investigatorAffiliation":45,"oldNameTitle":45,"oldOrganization":45},"SPONSOR","100505477","phase-1-hf158k1-in-patients-with-her-2-expressing-advanced-solid-tumors-100505477",false,"NCT05861895","HF158K1 in Patients With HER-2 Expressing Advanced Solid Tumors","A Phase 1 Clinical Study to Investigate the Safety, Tolerability, and Preliminary Efficacy of HF158K1 in Participants With HER-2 Expressing Advanced Solid Tumors","Inclusion Criteria:\n\n1. Voluntary to participate and sign ICF.\n2. Age ≥ 18 and ≤ 75 years.\n3. Unresectable or metastatic advanced solid tumors with HER-2 expression (IHC 3+, 2+, or 1+).\n4. ECOG score 0-1.\n5. Expected survival ≥ 6 months.\n6. At least one measurable lesion per RECIST v1.1.\n7. Adequate organ function: ANC ≥ 1.5×10⁹\u002FL, LYM ≥ 1.0×10⁹\u002FL, PLT ≥ 90×10⁹\u002FL, HGB ≥ 8.0 g\u002FdL; APTT ≤ 1.5×ULN, INR ≤ 1.5; TBIL ≤ 1.5×ULN, ALT\u002FAST ≤ 2.5×ULN (≤ 5×ULN if liver metastases); CrCl ≥ 30 mL\u002Fmin; LVEF ≥ 50%.\n8. Agreement to use effective contraception.\n\nExclusion Criteria:\n\n1. Cumulative doxorubicin dose ≥ 350 mg\u002Fm² or prior anthracycline-induced cardiotoxicity.\n2. Current use of immunosuppressants or systemic corticosteroids (\\> 10 mg\u002Fday prednisone).\n3. Prior anti-tumor therapy \\\u003C 2 weeks (4 weeks for nitrosourea\u002Fmitomycin C).\n4. Symptomatic CNS metastases.\n5. Unresolved AEs from prior therapy \\> Grade 1.\n6. Serious cardiovascular diseases (thromboembolic events within 3 months, NYHA III-IV, ACS within 6 months, or uncontrolled hypertension).\n7. Active infection or unexplained fever \\> 38.5°C.\n8. HIV, active HBV or HCV.\n9. Pregnant or breastfeeding.","ALL","18 Years","75 Years",{"count":96,"type":97},84,"ESTIMATED","INTERVENTIONAL",[100],"PHASE1","HF158K1 is an investigational liposome form of doxorubicin hydrochloride, an anthracycline topoisomerase inhibitor, encapsulated by lipid membranes containing TL01, a HER2-directed Trastuzumab Fab fragment conjugated lipid.",[103],"Solid Tumors, Adult","2026-06-25",{"date":106,"type":107},"2026-06-26","ACTUAL",{"date":109,"type":107},"2023-12-12",{"date":111,"type":97},"2027-12-23",{"name":5,"class":6},2]