[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"HighField Biopharmaceuticals Corporation\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":112},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,41,70,90],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"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":20,"type":21},84,"ESTIMATED","INTERVENTIONAL",[24],"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.",[27],"Solid Tumors, Adult","RECRUITING","2026-06-25",{"date":31,"type":32},"2026-06-26","ACTUAL",{"date":34,"type":32},"2023-12-12",{"date":36,"type":21},"2027-12-23",{"name":38,"class":39},"HighField Biopharmaceuticals Corporation","INDUSTRY",2,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":48,"targetDuration":4,"studyType":22,"phases":50,"briefSummary":52,"conditions":53,"keywords":56,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":69},"100645077","phase-2-a-study-of-hf1k16-combined-with-bevacizumab-in-patients-with-recurrent-or-progressive-glioma-100645077","NCT07678684","A Study of HF1K16 Combined With Bevacizumab in Patients With Recurrent or Progressive Glioma","A Multicenter, Open-Label, Adaptive Phase Ⅱ Clinical Study of HF1K16 Combined With Bevacizumab in Recurrent or Progressive Glioma","Inclusion Criteria:\n\n1. The patient and\u002For guardian must voluntarily sign and date a written informed consent form.\n2. Age ≥ 18 years and ≤ 75 years at the time of informed consent signing, male or female.\n3. Confirmed diagnosis of glioma by histopathology and molecular pathology, with recurrent or progressive disease following prior therapy, and no available standard treatment or intolerance to standard treatment.\n4. Expected survival time of at least 3 months.\n5. Karnofsky Performance Status (KPS) score ≥ 60.\n6. Adequate organ and bone marrow function as defined by the following criteria:\n\n   * Bone marrow reserve: absolute neutrophil count ≥ 1.5×10⁹\u002FL, platelet count ≥ 90×10⁹\u002FL, and hemoglobin ≥ 9.0 g\u002FdL (without transfusion or hematopoietic growth factor support within 14 days);\n   * Coagulation function: activated partial thromboplastin time (APTT) ≤ 1.5×ULN, and international normalized ratio (INR) ≤ 1.5×ULN;\n   * Hepatic function: total bilirubin (TBIL) ≤ 1.5×ULN, and alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5×ULN; in the presence of liver metastases, ALT and AST ≤ 5×ULN and TBIL ≤ 3×ULN;\n   * Renal function: creatinine clearance ≥ 60 mL\u002Fmin (calculated using the Cockcroft-Gault formula);\n   * Left ventricular ejection fraction (LVEF) ≥ 50%;\n   * QTcF interval on electrocardiogram \\\u003C 450 ms (males) or \\\u003C 470 ms (females).\n7. Subjects of reproductive potential (including male subjects) must agree to avoid pregnancy and use effective contraceptive measures with their partners during the study period and for 6 months after the last dose. A negative serum pregnancy test must be confirmed between screening and prior to the first dose.\n\nExclusion Criteria:\n\n1. Any active autoimmune disease, or a history of autoimmune disease requiring systemic steroid therapy, with a daily prednisone dose \\> 10 mg or equivalent corticosteroid within 2 weeks prior to study treatment.\n2. Uncontrolled seizures, hypertension, or psychiatric disorder at screening.\n3. Severe infection occurring within 4 weeks prior to the first dose, including but not limited to complicated infection requiring hospitalization, sepsis, or severe pneumonia; active infection requiring systemic anti-infective therapy within 2 weeks prior to the first dose, except for antiviral therapy for hepatitis B or hepatitis C.\n4. Third-space effusion that cannot be effectively controlled by drainage or other measures.\n5. Participation in another clinical trial of an investigational drug within 4 weeks prior to enrollment.\n6. Receipt of any anti-tumor therapy including chemotherapy, targeted therapy, biologic therapy, immunotherapy, radical radiotherapy, or major surgery within 2 weeks prior to enrollment or within 3 half-lives (whichever is shorter).\n7. Any other active malignancy within 5 years prior to enrollment. Subjects with other malignancies cured by local therapy (e.g., basal cell or squamous cell carcinoma of the skin, carcinoma in situ of the cervix) are excepted.\n8. Patients with hyperthyroidism are excluded. Subjects with hypothyroidism on a stable dose of thyroid hormone replacement therapy with stable thyroid function (TSH ≤ 10 μIU\u002FmL and no clinical manifestations of hypothyroidism) may be enrolled.\n9. Failure to recover from all adverse events due to prior therapy to Grade ≤ 1 (per CTCAE v5.0) or to baseline levels, except for toxicities deemed by the investigator to pose no safety risk (such as alopecia, Grade 2 peripheral neuropathy, hypothyroidism stabilized with hormone replacement therapy, etc.).\n10. Any active cardiac disease within 6 months prior to the first dose, including New York Heart Association (NYHA) Class II-IV cardiac dysfunction, congestive heart failure, myocardial infarction, unstable angina, and\u002For stroke or other cardiovascular or cerebrovascular events of Grade 3 or higher, or left ventricular ejection fraction (LVEF) \\\u003C 50%.\n11. HIV infection, active HBV infection (HBV DNA above the upper limit of normal), or active HCV infection (HCV RNA above the upper limit of normal).\n12. Any other serious systemic disease or any other condition that, in the opinion of the investigator, would render the subject ineligible for participation in this clinical study.",{"count":49,"type":21},30,[51],"PHASE2","The primary purpose of this Phase II study is to evaluate the preliminary anti-tumor efficacy of HF1K16 in combination with Bevacizumab in patients with recurrent or progressive glioma. The study also evaluates the safety and tolerability of the combination therapy.",[54,55],"Glioma","Adult",[57,58,59],"Drug Combinations","Drug Safety","Drug Tolerance","NOT_YET_RECRUITING","2026-06-24",{"date":63,"type":32},"2026-07-01",{"date":65,"type":21},"2026-06-30",{"date":67,"type":21},"2028-12-31",{"name":38,"class":39},1,{"id":71,"slug":72,"hasResults":11,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":4,"eligibilityCriteria":76,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":77,"targetDuration":4,"studyType":22,"phases":79,"briefSummary":80,"conditions":81,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":86,"completionDateStruct":87,"leadSponsor":89,"locationsCount":69},"100638406","phase-1-safety-and-activity-of-hf50-in-patients-with-advanced-solid-tumors-100638406","NCT07601334","Safety and Activity of HF50 in Patients With Advanced Solid Tumors","A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Anti-tumor Activity of HF50 in Patients With Advanced Solid Tumors","Inclusion Criteria:\n\n* Voluntary participation: Capable of giving signed informed consent and able to comply with all study-related procedures.\n* Age: Adults \\>= 18 years of age at the time of signing informed consent; male or female.\n* Disease Status: Participants with histologically or cytologically confirmed advanced solid tumors that are unresectable or metastatic, who have failed or are intolerant to standard therapies, or for whom no effective therapy currently exists. Examples include HER2-expressing gynecological tumors and recurrent ovarian clear cell carcinoma after failure of platinum-based chemotherapy.\n* Performance Status: Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1.\n* Life Expectancy: Anticipated survival of no less than 6 months.\n* Measurable Disease: At least one measurable lesion according to RECIST v1.1 definitions.\n* Organ and Bone Marrow Function:\n\nBone Marrow Reserve: Absolute neutrophil count (ANC) \\>= 1.5 x 10\\^9\u002FL, lymphocyte count \\>= 1.0 x 10\\^9\u002FL, platelet count \\>= 90 x 10\\^9\u002FL, and hemoglobin \\>= 9.0 g\u002FdL (no blood transfusion or hematopoietic stimulators within 14 days).\n\nCoagulation Function: Activated partial thromboplastin time (APTT) \\\u003C= 1.5 x ULN, and International Normalized Ratio (INR) \\\u003C= 1.5.\n\nLiver Function: Total bilirubin (TBIL) \\\u003C= 1.5 x ULN, and ALT and AST \\\u003C= 2.5 x ULN. For participants with liver metastases: ALT and AST \\\u003C= 5 x ULN, and TBIL \\\u003C= 3 x ULN.\n\nRenal Function: Creatinine clearance \\>= 50 mL\u002Fmin (calculated using the Cockcroft-Gault formula).\n\n* Contraception: Participants of reproductive potential (including males) must agree to use effective contraception from study entry through 6 months after the last dose. Female participants of childbearing potential must have a negative serum pregnancy test during screening and prior to the first dose.\n\nExclusion Criteria:\n\n* Autoimmune Disease: Any active autoimmune disease or history of autoimmune disease deemed unsuitable by the investigator. Exceptions include skin conditions not requiring systemic treatment (e.g., eczema \\\u003C 10% of body surface area, vitiligo, psoriasis, alopecia) and resolved childhood asthma.\n* Corticosteroids\u002FImmunosuppressants: Current use of immunosuppressants or systemic corticosteroids (\\> 10 mg\u002Fday prednisone or equivalent) within 4 weeks prior to the first dose. Topical steroid use is permitted.\n* Prior Anti-tumor Therapy: Receipt of systemic chemotherapy, radiotherapy, targeted therapy, or immunotherapy within 2 weeks prior to dosing (4 weeks for nitrosoureas or mitomycin C); or other therapies (endocrine therapy, TCM, localized palliative radiotherapy) within 2 weeks.\n* CNS Metastasis: Clinically symptomatic brain or meningeal metastases. Participants with treated brain metastases are eligible if radiographic stability is maintained for \\>= 28 days, systemic steroids have been discontinued for \\> 14 days, and the participant is asymptomatic.\n* Toxicity Recovery: Failure to recover from all adverse events of prior therapies to \\\u003C= Grade 1 (NCI CTCAE v5.0) or baseline, except for alopecia, Grade 2 peripheral neuropathy, or stable hypothyroidism on hormone replacement.\n* Cardiovascular History: Including thromboembolic events within 3 months; NYHA Class III to IV congestive heart failure; acute coronary syndrome, aortic dissection, stroke, or other Grade \\>= 3 cardiovascular events within 6 months; or uncontrolled hypertension (SBP \\> 160 mmHg or DBP \\> 100 mmHg).\n* Infection: Active infection or unexplained fever \\> 38.5 degrees C within 1 week prior to the first dose (tumor-related fever is permitted per investigator judgment).\n* Viral Infection: HIV infection, active HBV (HBV DNA \\> ULN), or active HCV (HCV RNA \\> ULN).\n* Gastrointestinal Symptoms: Significant digestive system symptoms or other factors requiring intervention within 4 weeks prior to the first dose.\n* Pregnancy\u002FLactation: Female participants who are pregnant or breastfeeding.\n* Other: Any other serious systemic disease or reason that, in the investigator's opinion, makes the participant unsuitable for the study.",{"count":78,"type":21},45,[24],"A study to assess the safety, tolerability, and pharmacokinetics of HF50 in participants with advanced solid tumors.",[82],"Advanced Solid Tumors","2026-05-15",{"date":85,"type":32},"2026-05-22",{"date":65,"type":21},{"date":88,"type":21},"2029-06-30",{"name":38,"class":39},{"id":91,"slug":92,"hasResults":11,"nctId":93,"briefTitle":94,"officialTitle":95,"acronym":96,"eligibilityCriteria":97,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":98,"targetDuration":4,"studyType":22,"phases":100,"briefSummary":102,"conditions":103,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":105,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":69},"100579338","early-phase-1-hf50-in-her-2-positive-and-low-expression-advanced-solid-tumors-100579338","NCT06822998","HF50 in HER-2 Positive and Low-expression Advanced Solid Tumors","An Open-label, Single-arm, Non-randomized, Single-center, Dose-escalation Study to Evaluate the Safety, Tolerability, and Preliminary Antitumor Activity of HF50 in Subjects With HER-2 Positive and HER-2 Low-expression Advanced Solid Tumors","HF50","Inclusion Criteria:\n\n* Participants must voluntarily provide written informed consent (ICF) prior to any study-related procedures, and be capable of complying with all protocol requirements.\n* Adult participants aged between 18 and 75 years (inclusive) at the time of ICF signing.\n* Histologically or cytologically confirmed advanced HER-2 positive or HER-2 low-expression solid tumors that are unresectable, metastatic, or have relapsed after standard therapies, are intolerant to standard therapies (e.g., chemotherapy, targeted therapy), or lack effective treatment options.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Life expectancy of at least 3 months.\n* At least one measurable lesion as defined by RECIST version 1.1.\n* Adequate organ and bone marrow function as demonstrated by the following laboratory parameters:Hematologic Function:Absolute neutrophil count (ANC) ≥1.5×10⁹\u002FL、Lymphocyte count ≥1.0×10⁹\u002FL、Platelet count ≥90×10⁹\u002FL、Hemoglobin ≥9.0 g\u002FdL (without transfusion or erythropoietin-stimulating agents within 14 days)； Coagulation Parameters:Activated partial thromboplastin time (aPTT) ≤1.5×ULN、 International normalized ratio (INR) ≤1.5. Hepatic Function:Total bilirubin (TBIL) ≤1.5×ULN、Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5×ULN (≤5×ULN for participants with liver metastases, and TBIL ≤3×ULN)； Renal Function:Creatinine clearance (CrCl) ≥50 mL\u002Fmin (Cockcroft-Gault formula).\n* Female participants of childbearing potential must have a negative serum pregnancy test at screening and prior to the first dose. Male and female participants of childbearing potential must agree to use effective contraception during the study and for 6 months after the last dose.\n\nExclusion Criteria:\n\n* History of active autoimmune disease or autoimmune disease considered unsuitable for study participation, with exceptions for localized skin conditions (e.g., eczema involving \\\u003C10% of body surface area, vitiligo, psoriasis, alopecia) or childhood asthma resolved without treatment in adulthood.\n* Current use of immunosuppressants or systemic corticosteroids (\\>10 mg\u002Fday prednisone or equivalent) within 4 weeks prior to the first dose, except for local steroid use.\n* Receipt of systemic chemotherapy, radiotherapy, targeted therapy, or immunotherapy less than 2 weeks (or 4 weeks for nitrosourea or mitomycin C) or within 5 half-lives of the prior therapy before the first dose.\n* Symptomatic brain metastases or leptomeningeal disease unless adequately treated (e.g., surgery or radiotherapy) with no evidence of progression for ≥28 days and off systemic steroids for ≥14 days prior to the first dose.\n* Unresolved toxicities from prior therapies ≥Grade 2 (CTCAE v5.0) at baseline, except for toxicities deemed by the investigator to pose no safety risk (e.g., alopecia, stable hypothyroidism with hormone replacement).\n* Significant cardiovascular or cerebrovascular conditions, including but not limited to:Thromboembolic events requiring therapeutic anticoagulation within 3 months prior to the first dose.NYHA Class III or IV heart failure.Acute coronary syndrome, congestive heart failure, aortic dissection, or stroke within 6 months prior to the first dose.Uncontrolled hypertension (systolic blood pressure \\>160 mmHg or diastolic blood pressure \\>100 mmHg), unless controlled with antihypertensive medication.\n* Active infection or unexplained fever \\>38.5°C within 1 week prior to the first dose (tumor-related fever may be eligible at the investigator's discretion).\n* Known HIV infection, active hepatitis B virus (HBV) infection (HBV DNA \\>ULN), or active hepatitis C virus (HCV) infection (HCV RNA \\>ULN).\n* Gastrointestinal symptoms or other conditions requiring intervention within 4 weeks prior to the first dose that would, in the investigator's judgment, impair study participation.\n* Pregnant or breastfeeding women.\n* Any other severe systemic disease, psychological condition, or significant clinical abnormality deemed unsuitable for study participation by the investigator.",{"count":99,"type":21},10,[101],"EARLY_PHASE1","This is an open-label, single-arm, non-randomized, single-center, dose-escalation study designed to evaluate the safety and tolerability of HF50 in patients with HER-2 positive and HER-2 low-expression advanced solid tumors. The primary objectives are to assess the safety, tolerability, and determine the maximum tolerated dose (MTD) and\u002For recommended Phase II dose (RP2D) of HF50. Secondary objectives include evaluating the pharmacokinetic (PK) profile and preliminary antitumor activity of HF50.",[82],"2025-08-12",{"date":106,"type":32},"2025-08-17",{"date":108,"type":32},"2025-06-11",{"date":110,"type":21},"2026-06-01",{"name":38,"class":39},""]