[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Hanx Biopharmaceuticals (Wuhan) Co., Ltd.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":67},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,43],{"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":26,"conditions":27,"keywords":29,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":4},"100618580","phase-1-a-clinical-study-of-hx111-in-patients-with-advanced-solid-tumor-and-lymphoma-100618580",false,"NCT07333469","A Clinical Study of HX111 in Patients With Advanced Solid Tumor and Lymphoma","A Phase I\u002FIIa Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Clinical Efficacy of HX111 in Patients With Advanced Solid Tumor and Lymphoma","Inclusion Criteria:\n\n* 1\\. Able to understand and voluntarily sign the Informed Consent Form (ICF); 2. Male or female subject aged 18 to 70 years, inclusive. 3. Eastern Cooperative Oncology Group performance status of 0 to 1. 4. Life expectancy of ≥3 months; 5. Histologically confirmed advanced solid tumors (including sarcomas, head and neck squamous carcinoma, cervical cancer, breast cancer, etc.,) or advanced lymphomas (including peripheral T-cell lymphoma-not otherwise specified, Angioimmunoblastic T-cell Lymphoma, Extranodal Natural Killer\u002FT-cell Lymphoma (nasal type), adult T-cell lymphoma\u002Fleukemia, Anaplastic Large Cell Lymphoma, and other EBV+ lymphomas) that is refractory\u002Frelapsed to standard therapies, or for which no effective standard therapy , or or for which the subject refuses standard treatment is available,.\n\n  6\\. For advanced solid tumors At least one measurable lesion per RECIST v1.1; 7. For patients with lymphoma:\n\n  • Lymphoma diagnosed according to the 2022 WHO Classification, 5th Edition, and meeting the definition of relapsed\u002Frefractory disease.\n\n  • At least one measurable lesion according to the Lugano criteria within 4 weeks prior to the first dose; Measurable lesion: Lymph node with the longest diameter \\>15 mm, extranodal lesions \\>10 mm; Lesions previously treated with radiotherapy or other local therapies are considered measurable if disease progression has been documented and they meet the definition of measurable lesions.\n\nInclusion Criteria\n\n1. Able to understand and voluntarily sign the Informed Consent Form (ICF);\n2. Male or female subject aged 18 to 70 years, inclusive.\n3. Eastern Cooperative Oncology Group performance status of 0 to 1.\n4. Life expectancy of ≥3 months;\n5. Histologically confirmed advanced solid tumors (including sarcomas, head and neck squamous carcinoma, cervical cancer, breast cancer, etc.,) or advanced lymphomas (including peripheral T-cell lymphoma-not otherwise specified, Angioimmunoblastic T-cell Lymphoma, Extranodal Natural Killer\u002FT-cell Lymphoma (nasal type), adult T-cell lymphoma\u002Fleukemia, Anaplastic Large Cell Lymphoma, and other EBV+ lymphomas) that is refractory\u002Frelapsed to standard therapies, or for which no effective standard therapy , or or for which the subject refuses standard treatment is available,.\n6. For advanced solid tumors At least one measurable lesion per RECIST v1.1;\n7. For patients with lymphoma:\n\n   • Lymphoma diagnosed according to the 2022 WHO Classification, 5th Edition, and meeting the definition of relapsed\u002Frefractory disease.\n\n   • At least one measurable lesion according to the Lugano criteria within 4 weeks prior to the first dose; Measurable lesion: Lymph node with the longest diameter \\>15 mm, extranodal lesions \\>10 mm; Lesions previously treated with radiotherapy or other local therapies are considered measurable if disease progression has been documented and they meet the definition of measurable lesions.\n8. Adequate organ function, as indicated by the following laboratory values, within 7 days before first dose (unless specified):\n\n   Hematology (use of hematopoietic growth factors and transfusions not allowed within 14 days prior to the start of the first study treatment) • Absolute neutrophil count (ANC) ≥1.5 × 109\u002FL; for those with bone marrow involvement, ANC ≥1.0 × 109\u002FL Solid tumor\n\n   • Hemoglobin ≥100 g\u002FL\n\n   • Platelet count ≥100 × 109\u002FL lymphoma\n\n   • Hemoglobin (HB) ≥90 g\u002FL; for those with bone marrow involvement, HB ≥80 g\u002FL;\n\n   • Platelet count ≥75×109\u002FL (without bone marrow involvement), platelet count ≥50.0×109\u002FL (with bone marrow or splenic involvement)； Hepatic：\n\n   • Serum total bilirubin ≤1.5×upper limit of normal (ULN); or for patients with total bilirubin levels \\>1.5ULN but direct bilirubin ≤ULN\n\n   • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5×ULN (for subjects with liver metastases, ALT and AST ≤5×ULN) Renal：\n\n   • Serum creatinine ≤1.5×ULN Coagulation function ( within 14 days before first dose)：\n\n   • Prothrombin time\u002FInternational Normalized Ratio ≤1.5×ULN or activated partial thromboplastin time ≤1.5×ULN (for subjects receiving anticoagulants, the prothrombin time or activated partial thromboplastin time must be within the normal range for their anticoagulant regimen)。 Echocardiogram ( within 28 days before first dose)：\n   * LVEF≥50%\n9. Male subjects: Must agree to use the contraception methods recommended in Appendix 5 during the treatment period and for at least 12 months after the last dose of the study treatment.\n\nFemale subjects: Contraception; or not having reproductive potential as defined in Appendix 5; or if of reproductive potential, must agree to use effective contraception during the study treatment period and for at least 12 months after the last dose of study treatment. Female subjects of reproductive potential are required to have a negative pregnancy test within 14 days before administration of the study drug.\n\nExclusion Criteria:\n\n* 1\\. Prior malignancy active within the previous 2 years except for the tumor for which a subject is enrolled in the study and locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer or carcinoma in situ of the cervix or breast.\n\nKnown allergic reactions to prior recombinant humanized anti-OX40 monoclonal antibody drugs or their components.\n\n2\\. Received any anti-tumor treatment (chemotherapy, radiotherapy, study drugs including small molecule inhibitors, endocrine therapy, immunotherapy, etc.) within 4 weeks or 5 half-lives of that treatment (whichever is shorter) prior to the first dose of study treatment .\n\n3\\. Received any investigational anti-tumor treatment within 4 weeks prior to the first dose of study treatment 4. History of Grade ≥2 peripheral neuropathy 5. Toxicities from prior anti-tumor treatments have resolved to ≤Grade 1 or to baseline, with the exception of alopecia and Grade 2 hypothyroidism that can be managed with hormone replacement therapy.\n\n6\\. Any subject known to be positive for human immunodeficiency virus, or active hepatitis B virus or hepatitis C virus infection.\n\n7\\. Female subject who is pregnant or lactating. 8. Subjects with a history of or presently experiencing an active autoimmune disease (e.g., systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, autoimmune thyroid disease, multiple sclerosis, vasculitis, glomerulitis, etc.) within 2 years of initiating study drug, or those who are at high risk of relapse (e.g., receiving an immunosuppressive treatment for an organ transplant); however, subjects with the following are allowed to enroll:\n\n* Type I diabetes that is stable after a fixed dose of insulin or other hypoglycemic\n* Only requiring hormone replacement therapy for autoimmune hypothyroidism\n* Skin disease that does not require systemic treatment such as eczema, rash that accounts for \\\u003C10% of the body surface, psoriasis without ophthalmic symptoms.\n\n  9\\. Subjects who have undergone any major surgery (excluding diagnostic surgery) within 4 weeks prior to the first study treatment, and\u002For subjects who may require major surgery during the study period including the screening period.","ALL","18 Years","70 Years",{"count":20,"type":21},70,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE1","PHASE2","The study will consist of a Phase I dose-escalation and Phase IIa dose-expansion component. Phase I dose-escalation phase will establish the maximum tolerated dose (MTD) and\u002For recommended Phase 2 dose (RP2D),and evaluate the preliminary antitumor activity of HX111.",[28],"Solid Tumor and Lymphoma",[30],"Phase I\u002FIIa","NOT_YET_RECRUITING","2026-01-11",{"date":34,"type":35},"2026-01-13","ACTUAL",{"date":37,"type":21},"2026-01-19",{"date":39,"type":21},"2030-01-19",{"name":41,"class":42},"Hanx Biopharmaceuticals (Wuhan) Co., Ltd.","INDUSTRY",{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":50,"enrollmentInfo":51,"targetDuration":4,"studyType":22,"phases":53,"briefSummary":54,"conditions":55,"keywords":4,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":59,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":66},"100566017","phase-1-hx044fih-study-in-patients-with-advanced-solid-tumor-malignancies-100566017","NCT06649708","HX044,FIH Study in Patients with Advanced Solid Tumor Malignancies","A Phase I\u002FIIa, First-in-Human Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Initial Efficacy of HX044 in Patients with Advanced Solid Tumor Malignancies","Inclusion Criteria:\n\n1. Subjects must voluntarily agree to participate by providing written informed consent and agreeing to comply with protocol and scheduled visit;\n2. Male or female subject aged 18-75 years, inclusive;\n3. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1;\n4. Histologically confirmed advanced malignant solid tumor that is refractory\u002Frelapsed to standard therapies, or for which no effective standard therapy is available, or the subject refuses standard therapy.\n5. At least 1 measurable tumor (It is acceptable to allow patients with no measurable lesion but evaluable tumor lesion in the first 2 dose levels in Phase I and at least 1 measurable tumor lesion must be present in Phase IIa) according to RECIST v1.1\n6. Life expectancy ≥ 12 weeks.\n7. Adequate organ function, as indicated by the following laboratory values: •Hematology (no growth factor and blood transfusion are allowed within 14 days before start of first dose study treatment): Hemoglobin ≥90g\u002FL Absolute neutrophil count ≥1.5×109\u002FL Platelet count ≥100×109\u002FL\n\n   * Hepatic: Serum total bilirubin ≤1.5 × upper limit of normal (ULN); or direct bilirubin ≤ULN for patients with total bilirubin levels \\>1.5 × ULN\n   * Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN (ALT and AST ≤ 5 × ULN for subjects with liver metastases)\n   * Renal:Serum creatinine ≤1.5 × ULN\n   * Coagulation: Prothrombin time\u002Finternational normalized ratio ≤1.5 × ULN or activated partial thromboplastin time ≤ 1.5 × ULN (for subjects on anticoagulants, prothrombin time or activated partial thromboplastin time must be within the normal range foranticoagulants).\n\nExclusion Criteria:\n\n1. Prior malignancy active within the previous 5 years except for the tumor for which a subject is enrolled in the study and locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer or carcinoma in situ of the cervix or breast.\n2. Receipt of any anticancer (chemotherapy, radiation therapy, investigational drugs including small molecular inhibitors, endocrine therapy, immunotherapy) therapy within 4 weeks prior to the first dose of study treatment or 5 half-lives of the therapy, whichever is shorter.\n3. Severe cardiovascular disease including symptomatic congestive heart failure (New York Heart Association class III or IV), unstable angina, uncontrolled hypertension, cardiac arrhythmia, a history of myocardial infarction within 6 months or a history of arterial thromboembolic event and pulmonary embolism within 3 months of the first dose of investigational agent, as follows:\n\n   * QT\u002FQTc interval prolongation (using Fredericia's QT correction formula) at baseline, Female \\> 470 ms, Male \\> 450 ms;\n   * Medications to prolong the QT\u002FQTc interval are currently being taken;\n   * Family history of long QT syndrome.\n4. Patients with a history of or presently experiencing an active autoimmune disease within 2 years of initiating study drug, or those who are at high risk of relapse ; however, subjects with the following are allowed to enroll:\n\n   * Type I diabetes that is stable after a fixed dose of insulin or other hypoglycemic;\n   * Only requiring hormone replacement therapy for autoimmune hypothyroidism;\n   * Skin disease that does not require systemic treatment such as eczema rash that accounts for \\\u003C10% of the body surface, psoriasis without ophthalmic symptoms.\n5. Subjects who received any major surgery within 4 weeks before the first dose of study treatment (except for diagnostic surgery), and\u002For subjects who may require major surgery during the study.\n6. Lung diseases such as, interstitial lung disease or pneumonia, pulmonary fibrosis, acute lung disease, interstitial pneumonia. Patients with well controlled chronic obstructive pulmonary disease (COPD) are allowed.\n7. Subjects with primary central nervous system (CNS) malignancies, symptomatic CNS metastases, symptomatic parenchymal brain leptomeningeal disease or spinal cord compression, except for the following: who has received prior treatment (surgery\u002Fradiotherapy) before signing informed consent form (ICF) and is clinically stable for at least 3 months is allowed (prior treatment with corticosteroids are permitted but must stop 14 days before commencing study treatment）\n8. Use of any live vaccines within 4 weeks before the first dose of study treatment.\n9. A history of psychotropic substance abuse who is unable to quit.\n10. Any patient with an uncontrolled illness such as cardiovascular and cerebrovascular diseases, diabetes, high blood pressure, et, and other severe, acute or chronic medical or psychiatric diseases or laboratory abnormalities that, in the Investigator's opinion, may increase the study-related risks or interfere with the interpretation of the findings.","75 Years",{"count":52,"type":21},100,[24,25],"The study will consist of a dose-escalation and dose-expansion component to establish the maximum tolerated dose (MTD) and\u002For recommended Phase 2 dose (RP2D), and to evaluate the preliminary antitumor activity of HX044.\n\nHX044 is an investigational drug that has not yet been approved by the Food and Drug Administration (FDA) or any other regulatory authorities for commercial purposes. This is the first study in which HX044 will be given to humans. The study drug has been tested in animals and was found to be well-tolerated with minimal side effects.",[56],"Advanced Solid Tumor Malignancies","RECRUITING","2025-01-13",{"date":60,"type":35},"2025-01-14",{"date":62,"type":35},"2024-12-30",{"date":64,"type":21},"2027-10-31",{"name":41,"class":42},3,""]