[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05861895":3,"trial-entities:NCT05861895":327,"trial-summary:NCT05861895":332},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":21,"primary_purpose":22,"phases":23,"enrollment_info":25,"interventions":28,"primary_outcomes":47,"secondary_outcomes":240,"sex":279,"minimum_age":280,"maximum_age":281,"healthy_volunteers":282,"eligibility_criteria":283,"std_ages":287,"locations":290,"central_contacts":322,"overall_officials":323,"references":325,"see_also_links":326},"NCT05861895","HF158K1-101","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","RECRUITING","2027-12-23","2026-03","2026-06-26","2023-12-12","HighField Biopharmaceuticals Corporation","INDUSTRY",true,"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.","This study is a multi-regional, open-label, multiple-dose administration dose-escalation and dose-expansion study, including a Dose-Escalation Phase (Ia) and a Dose-Expansion Phase (Ib).\n\nHF158K1 contains multiple copies of the targeting antibody on liposome surface. It is designed to bind and deliver the chemotherapeutic doxorubicin to tumor cells at even very low HER2 expression levels. The study recruits patients with unresectable or metastatic advanced solid tumors (HER-2 positive (IHC 3+, or IHC 2+ with ISH +) or HER-2 low expression (IHC 2+ with ISH -, or IHC 1+)) who have failed or are intolerant (disease progression, or intolerance to chemotherapy, targeted therapy, etc.) to standard treatment, or currently have no available treatment regimen.\n\nPhase 1a(Dose escalation) will assess the safety，tolerability，pharmacokinetics of HF158K1 in participants to determine the maximum tolerated dose (MTD) of HF158K1 through the incidence of dose-limiting toxicity (DLT).\n\nPhase 1b (Dose bridging) will be conducted in Chinese patients to bridge the safety and pharmacokinetic data between different ethnic populations.\n\nPhase 1c(Dose expansion) will assess safety and preliminary efficacy of HF158K1 in participants with specific tumor types in selected dose groups.",[19],"Solid Tumors, Adult",[],"INTERVENTIONAL","TREATMENT",[24],"PHASE1",{"count":26,"type":27},84,"ESTIMATED",[29,37,42],{"type":30,"name":31,"description":32,"armGroupLabels":33,"otherNames":35},"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.",[34],"Dose escalation: HF158K1 1.4 g lipid dose",[36],"Infusion",{"type":30,"name":38,"description":32,"armGroupLabels":39,"otherNames":41},"HF158K1 \u002F 2.2 g lipid dose",[40],"Dose escalation: HF158K1 2.2 g lipid dose",[36],{"type":30,"name":43,"description":32,"armGroupLabels":44,"otherNames":46},"HF158K1 \u002F 2.9 g lipid dose",[45],"Dose escalation: HF158K1 2.9 g lipid dose",[36],[48,52,56,60,63,66,69,72,75,78,81,84,87,90,93,96,99,102,105,108,111,114,117,120,123,126,129,131,133,136,139,142,145,148,151,154,157,160,163,166,169,172,175,178,181,184,187,190,193,196,199,202,205,208,211,214,217,220,223,226,229,232,236],{"measure":49,"description":50,"timeFrame":51},"Incidence of Adverse Events","Defined by the Common Terminology Criteria for Adverse Events version 5.0 (CTCAE V5.0)","The period of AE collection starts after the participant receives the investigational drug, until 28±3 days after the EOT\u002Fearly withdrawal or before the participant starts another anti-tumor treatment (whichever occurs first).",{"measure":53,"description":54,"timeFrame":55},"Incidence of dose-limiting toxicities(DLT)","Observe the dose limiting toxicity, and Incidence of dose-limiting toxicities(DLT) will be assessed","The DLT evaluation period is from the first administration of the investigational drug to the end of the first treatment cycle, lasting for 21 days.（only Ia）",{"measure":57,"description":58,"timeFrame":59},"Red blood cell count in whole blood sample","Changes from baseline for Red blood cell count in whole blood","Baseline, Day 1 of each 21-day cycle, and at the End of Treatment (EOT) visit (up to 1 year)",{"measure":61,"description":62,"timeFrame":59},"White blood cell in whole blood sample","Changes from baseline for white blood cell count in whole blood",{"measure":64,"description":65,"timeFrame":59},"Hematocrit in whole blood sample","Changes from baseline for Hematocrit in whole blood",{"measure":67,"description":68,"timeFrame":59},"Neutrophil count in whole blood sample","Changes from baseline for neutrophil count in whole blood",{"measure":70,"description":71,"timeFrame":59},"Hemoglobin concentration in whole blood sample","Changes from baseline for hemoglobin concentration in whole blood",{"measure":73,"description":74,"timeFrame":59},"Percentage of lymphocytes (LYM%)","Changes from baseline for Percentage of lymphocytes (LYM%) in whole blood",{"measure":76,"description":77,"timeFrame":59},"Lymphocyte count","Changes from baseline for Lymphocyte count in whole blood",{"measure":79,"description":80,"timeFrame":59},"Percentage of neutrophils (NEU%) Percentage of neutrophils (NEU%)","Changes from baseline for Percentage of neutrophils (NEU%) in whole blood",{"measure":82,"description":83,"timeFrame":59},"Platelet count in whole blood sample","Changes from baseline for Platelet count in whole blood",{"measure":85,"description":86,"timeFrame":59},"Prothrombin time in whole blood sample","Changes from baseline for Prothrombin time in whole blood sample",{"measure":88,"description":89,"timeFrame":59},"International normalized ratio in whole blood sample","Changes from baseline for international standardized ratio in whole blood sample",{"measure":91,"description":92,"timeFrame":59},"Fibrinogen in whole blood sample","Changes from baseline for Fibrinogen in whole blood",{"measure":94,"description":95,"timeFrame":59},"Activated partial prothrombin time in whole blood sample","Changes from baseline for activated partial thromboplastin time in whole blood sample",{"measure":97,"description":98,"timeFrame":59},"Total bilirubin concentration in whole blood sample","Changes from baseline for total bilirubin concentration in whole blood sample",{"measure":100,"description":101,"timeFrame":59},"ALT concentration in whole blood sample","Changes from baseline for alanine aminotransferase(ALT) concentration in whole blood sample",{"measure":103,"description":104,"timeFrame":59},"AST concentration in whole blood sample","Changes from baseline for aspartate aminotransferase(AST) concentration in whole blood sample",{"measure":106,"description":107,"timeFrame":59},"Total protein concentration in whole blood sample","Changes from baseline for total protein concentration in whole blood sample",{"measure":109,"description":110,"timeFrame":59},"Urea concentration in whole blood sample","Changes from baseline for urea concentration in whole blood sample",{"measure":112,"description":113,"timeFrame":59},"Creatinine concentration in whole blood sample","Changes from baseline for creatinine concentration in whole blood sample",{"measure":115,"description":116,"timeFrame":59},"Total cholesterol concentration in whole blood sample","Changes from baseline for total cholesterol concentration in whole blood sample",{"measure":118,"description":119,"timeFrame":59},"Triglycerides concentration in whole blood sample","Changes from baseline for triglycerides concentration in whole blood sample",{"measure":121,"description":122,"timeFrame":59},"HDL-C in whole blood sample","Changes from baseline for high density lipoprotein cholesterol (HDL-C) in whole blood sample",{"measure":124,"description":125,"timeFrame":59},"LDL-C in whole blood sample","Changes from baseline for low density lipoprotein cholesterol (LDL-C) in whole blood sample",{"measure":127,"description":128,"timeFrame":59},"Glucose in whole blood sample","Changes from baseline for Lactic dehydrogenase in whole blood",{"measure":130,"description":128,"timeFrame":59},"Alkaline phosphatase in whole blood sample",{"measure":132,"description":128,"timeFrame":59},"Lactic dehydrogenase in whole blood sample",{"measure":134,"description":135,"timeFrame":59},"Gamma-glutamyl transferase in whole blood sample","Changes from baseline for Gamma-glutamyl transferase in whole blood",{"measure":137,"description":138,"timeFrame":59},"Albumin in whole blood sample","Changes from baseline for Albumin in whole blood",{"measure":140,"description":141,"timeFrame":59},"Direct bilirubin in whole blood sample","Changes from baseline for Direct bilirubin in whole blood",{"measure":143,"description":144,"timeFrame":59},"Sodium in whole blood sample","Changes from baseline for Sodium in whole blood",{"measure":146,"description":147,"timeFrame":59},"Potassium in whole blood sample","Changes from baseline for Potassium in whole blood",{"measure":149,"description":150,"timeFrame":59},"Chloride in whole blood sample","Changes from baseline for Chloride in whole blood",{"measure":152,"description":153,"timeFrame":59},"Calcium in whole blood sample","Changes from baseline for Calcium in whole blood",{"measure":155,"description":156,"timeFrame":59},"Phosphate in whole blood sample","Changes from baseline for Phosphate in whole blood",{"measure":158,"description":159,"timeFrame":59},"Uric acid in whole blood sample","Changes from baseline for Uric acid in whole blood",{"measure":161,"description":162,"timeFrame":59},"Creatine kinase in whole blood sample","Changes from baseline for Creatine kinase in whole blood",{"measure":164,"description":165,"timeFrame":59},"Creatine kinase isoenzyme in whole blood sample","Changes from baseline for Creatine kinase isoenzyme in whole blood",{"measure":167,"description":168,"timeFrame":59},"Troponin-T (TnT) in whole blood sample","Changes from baseline for Troponin-T in whole blood",{"measure":170,"description":171,"timeFrame":59},"Troponin-I (TnI) in whole blood sample","Changes from baseline for Troponin-I in whole blood",{"measure":173,"description":174,"timeFrame":59},"Urine protein in urine sample","Changes from baseline for Urine protein in urine sample",{"measure":176,"description":177,"timeFrame":59},"Red blood cells in urine sample","Changes from baseline for Red blood cells in urine sample",{"measure":179,"description":180,"timeFrame":59},"White blood cells in urine sample","Changes from baseline for White blood cells in urine sample",{"measure":182,"description":183,"timeFrame":59},"PH in urine sample","Changes from baseline for pH in urine sample",{"measure":185,"description":186,"timeFrame":59},"Ketone bodies in urine sample","Changes from baseline for Ketone bodies in urine sample",{"measure":188,"description":189,"timeFrame":59},"Urine glucose in urine sample","Changes from baseline for Urine glucose in urine sample",{"measure":191,"description":192,"timeFrame":59},"Urine bilirubin in urine sample","Changes from baseline for Urine bilirubin in urine sample",{"measure":194,"description":195,"timeFrame":59},"Urine occult blood in urine sample","Changes from baseline for Urine occult blood in urine sample",{"measure":197,"description":198,"timeFrame":59},"Heart Rate in beats per minute in beats per minute of ECG","Changes from baseline for heart rate in beats per minute",{"measure":200,"description":201,"timeFrame":59},"RR Interval by ECG","Changes from baseline for RR interval by ECG",{"measure":203,"description":204,"timeFrame":59},"PR Interval by ECG","Changes from baseline for PR interval by ECG",{"measure":206,"description":207,"timeFrame":59},"QRS Interval by ECG","Changes from baseline for QRS interval by ECG",{"measure":209,"description":210,"timeFrame":59},"QT Interval by ECG","Changes from baseline for QT interval by ECG",{"measure":212,"description":213,"timeFrame":59},"QTcF by ECG","Changes from baseline for QTcF interval by ECG",{"measure":215,"description":216,"timeFrame":59},"Left ventricular ejection fraction measured by Echocardiography","Changes from baseline for Left ventricular ejection fraction measured by Echocardiography",{"measure":218,"description":219,"timeFrame":59},"Body (Ear) Temperature measurement in Vital Signs","Changes from baseline for Body (Ear) Temperature",{"measure":221,"description":222,"timeFrame":59},"Pulse measurement in Vital Signs","Changes from baseline for Pulse",{"measure":224,"description":225,"timeFrame":59},"Respiration Rate measurement in Vital Signs","Changes from baseline for respiration rate in breaths of Vital Signs",{"measure":227,"description":228,"timeFrame":59},"Sitting Systolic Blood Pressure","Changes from baseline for Sitting Systolic Blood Pressure",{"measure":230,"description":231,"timeFrame":59},"Sitting Diastolic Blood Pressure","Changes from baseline for Sitting Diastolic Blood Pressure",{"measure":233,"description":234,"timeFrame":235},"The recommended Phase II dose","Determine the Recommended Phase II Dose(mg\u002F㎡) of HF158K1 and provide references for dose selection in future clinical studies.","After the end of the dose Expansion Phase（only Ic）",{"measure":237,"description":238,"timeFrame":239},"Determine the maximum tolerated dose","The dose at which the incidence of DLT was closest to the target probability of toxicity (30%).","The first administration of the investigational drug to the end of the first treatment cycle, lasting for 21 days.",[241,245,248,251,254,257,260,263,267,271,275],{"measure":242,"description":243,"timeFrame":244},"HF158K1 pharmacokinetic parameters with Cmax","Maximum plasma concentration (Cmax) after administration of HF158K1","Within 336 hours after the first and second administration",{"measure":246,"description":247,"timeFrame":244},"AUC by plasma concentration of whole blood sample","Area under plasma concentration -time curve after dose",{"measure":249,"description":250,"timeFrame":244},"Tmax by plasma concentration of whole blood sample","Peak time (Tmax) after dose",{"measure":252,"description":253,"timeFrame":244},"T1\u002F2 by plasma concentration of whole blood sample","Elimination half-life (T1\u002F2) after dose",{"measure":255,"description":256,"timeFrame":244},"CL by plasma concentration of whole blood sample","Clearance (CL) after dose",{"measure":258,"description":259,"timeFrame":244},"Vd by plasma concentration of whole blood sample","Volume of distribution(Vd) after dose",{"measure":261,"description":262,"timeFrame":244},"AUClast by plasma concentration of whole blood sample","Ratios of geometric means of AUClast (Area under the plasma concentration-time curve from zero to time of last quantifiable concentration) after dose",{"measure":264,"description":265,"timeFrame":266},"The objective response rate(ORR) of HF158K1","ORR is defined as the proportion of participants with complete response or partial response (CR+PR)","ORR will be calculated for all participants who have received the investigational drug at least once and have undergone at least one tumor evaluation after administration, assessed up to 51 weeks.",{"measure":268,"description":269,"timeFrame":270},"disease control rate (DCR) of HF158K1","DCR is defined as the proportion of participants with complete response stable disease and partial response (CR+PR+SD)","DCR will be calculated for all participants who have received the investigational drug at least once and have undergone at least one tumor evaluation after administration, assessed up to 51 weeks.",{"measure":272,"description":273,"timeFrame":274},"duration of response(DOR) of HF158K1","For duration of response (DOR), the Kaplan-Meier survival curve will be plotted to analyze their maximum, minimum, median and 95% confidence interval descriptively statistically.","DOR will be calculated for all participants who have received the investigational drug at least once and have undergone at least one tumor evaluation after administration, assessed up to 51 weeks.",{"measure":276,"description":277,"timeFrame":278},"Analysis of immunogenicity","Immunogenicity analyses related to anti-TL01 antibody will be performed based on IMS(Immunogenicity Analysis Set).","On the first day of the first cycle, on the first day of the fourth cycle, on the 21st day of the eighth cycle","ALL","18 Years","75 Years",false,{"inclusion":284,"exclusion":285,"raw_text":286},[],[],"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.",[288,289],"ADULT","OLDER_ADULT",[291,306],{"facility":292,"status":8,"city":293,"state":294,"zip":295,"country":296,"contacts":297,"geoPoint":303},"Mary Crowley Cancer Research","Dallas","Texas","75241","United States",[298],{"name":299,"role":300,"phone":301,"email":302},"MINAL BARVE","CONTACT","972-566-3000","MBarve@MaryCrowley.org",{"lat":304,"lon":305},32.78306,-96.80667,{"facility":307,"status":8,"city":308,"state":309,"zip":310,"country":311,"contacts":312,"geoPoint":319},"Sun Yat-sen University Cancer Center","Guangzhou","Guangdong","510060","China",[313,316],{"name":314,"role":300,"email":315},"Kai Yao, PhD","yaokai@sysucc.org.cn",{"name":317,"role":318},"Kai Yao","PRINCIPAL_INVESTIGATOR",{"lat":320,"lon":321},23.11667,113.25,[],[324],{"name":299,"affiliation":292,"role":318},[],[],{"nct_id":4,"conditions":328,"biomarkers":330},[329],"Solid Neoplasm",[331],"ERBB2 Gene",{"nct_id":4,"found":15,"summary":333,"prompt_version":343},{"design":334,"status":335,"heading":336,"summary":337,"follow_up":338,"word_count":339,"commitments":340,"compensation":341,"drugs_mentioned":342},"This is an open-label study, meaning both you and the study team will know which treatment you are receiving. It involves different doses of HF158K1 and plans to enroll 84 participants.","completed","HF158K1 for HER-2 Expressing Advanced Solid Tumors","This study is testing a new treatment called HF158K1 for adults (ages 18-75) with advanced solid tumors that express HER-2 (a protein found on some cancer cells). HF158K1 is a special form of a chemotherapy drug designed to target HER-2 positive cancer cells. Researchers want to find out how safe HF158K1 is, what side effects it might cause, and how well it works. You might be able to join if your tumor expresses HER-2 and you have already tried standard treatments or have no other options. The study aims to enroll 84 participants.","Your safety will be monitored for about 28 days after your last treatment or early withdrawal, or until you start another anti-tumor treatment. Red blood cell counts will be tracked for up to 1 year.",93,"You would receive HF158K1 through an intravenous (IV) infusion lasting about 90 minutes. You would have blood tests at the start of each 21-day cycle and at the end of treatment.","Not stated in the trial record.",[],"v2"]